The right people. The right solution. The first time.

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www.nsf.org

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From Webinars

to Professional

Certification

1 hour webinars or 5 day intensive modular programs, we aim to ensure that the right education is delivered using internationally renowned specialists.

Many training providers focus upon what the requirements are and their impact; NSF, on the other hand, focuses on how to address the requirements and apply them in the most effective way within your business.

Flexible, Professional and

Career-Pathway Driven Education from the

Best in the Industry

Our Courses Drive Career Development

and Lead to Post-Graduate Qualification

If you study with NSF, no matter how long the course duration, we have ensured that the knowledge we provide forms part of an overall professional recognition and career development framework regardless of your location.

For those with EU regulatory compliance responsibility, our courses are set to meet the requirements of a Medical Device Qualified Person.

Our Course Content

We are public health and safety experts, with roots firmly fixed in the world of quality assurance, regulatory science and regulatory affairs associated with healthcare technologies and medicines. With that in mind we have developed a world-leading series of training and education services aimed specifically towards ensuring that professionals and companies alike can achieve confidence in their ability to act in the best interests of the patient, clinician, manufacturer and regulatory agency.

What our customers have said about our courses...

“

Great to have such

an applicable course

put on locally, excellent

expert panel.

”

Sarah Carpenter, Smith & Nephew

“

The day was excellent.

The technical content and

relevance was very good.

”

“

This course has perfectly

provided the learning

needed for current projects

at work.

”

“

Great course – challenging

with nowhere to hide in the

background, plenty of chances

to ask general questions.

”

Peter Iddon, Neotherix

Why train with us

?

Why train with us

?

Our In Company Services

All of our In Company courses drive career development and

lead to formal qualification.

We can bring any of our courses to you, either at your premises or at a venue local to you.

You can decide whether you would like the ‘off the peg’ courses or bespoke versions adapted to your particular products and company profile.

Recently provided in-company training programs include: • CE marking of Telehealth / eHealth applications • Design Control for auto-injectors and other

combination products

• Understanding the clinical requirements for Class III cardiovascular implants in EU clinical study sites • Planning biocompatibility testing strategies for global

regulatory submission

In Company Delivery

Our qualified tutors work with your company to outline exactly the types of regulatory compliance programs you would like to implement within your company. From simple ½ day briefings to full 5 day modular delivery, we are able to plan the training and education experience you require to address regulatory risks, enhance expertize and achieve career development for your people.

With further elective modules you can develop specific areas of expertize in In-Vitro Diagnostics, Clinical Data, Process Validation, Biological Evaluation or Auditing.

Executive Briefings

For people planning the future of the company and its products you need training and education to concentrate upon strategy, project planning, risk and budgets. Our executive briefings do exactly that; from courses outlining drug / device combination products to determining global market entry for high risk IVDs, our 1 day series of briefings

The right people. The right solution. The first time.™

will enable you to gain confidence in your strategic decisions. Ideal for:

• CEOs

• Leadership teams • Investment bankers

• Business development personnel

Team Leader Briefings

People who are actively doing the job and leading the team need to quickly understand why they are doing something so that they can quickly motivate, coach, support and lead their teams towards regulatory compliance. Our Team Leader briefings are fast-paced, example-driven practical courses aimed at keeping the balance of theory with reality in order to ensure the correct messages are issued.

From regulatory overviews to examining cases of where poor awareness has affected regulatory compliance, our team briefings are specifically aimed at large audiences in short sessions delivered by facilitators who keep the audience engaged and energized.

Workforce Briefings

External professionals explaining why it is important to maintain compliance to an entire workforce can sound rather academic; however it is critically important for medical technology organizations to ensure that their workforce understand that they are involved in some of the most important products in our lifetime. We have specialized large class developed lectures aimed towards engaging a general workforce and stimulating their thoughts and behaviors towards regulatory compliance. Our lectures focus on the human ‘whys’ rather than regulatory requirements, outlining the duty of care every employee has in ensuring that they make the right decisions that achieve a safe and effective product.

For more information about how NSF Medical Devices courses

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Professional Certificates

If you are not ready to enter into formal university study but you want to ensure you understand the theories and practices to achieve regulatory compliance in Design, Supply or Post Market of medical technologies then our professional certificates are an ideal qualification to meet the knowledge requirements of a modern day medical device regulatory compliance professional. With progression to Chartered Quality Professional status and recognition from allied professional institutions our professional certificates enable you to study the requirements but manage your time without the added burden of university study. Professional certificates meet the education and training requirements of the PgCerts and PgDip but do not include the rigorous academic assessment.

For people who do not have the necessary time for academic study or are already qualified at relevant degree level. Professional Certificate – Medical Device QARA – Design

Professional Certificate – Medical Device QARA – Regulatory

Professional Certificate – Medical Device QARA – Regulatory Sciences Professional Certificate – Medical Device QARA – Medical Device Auditor

Professional Certificate – Medical Device QARA – Medical Device Quality Assurance

Post Graduate Certificates

Our Post Graduate certificates enable you to study the specific elements that impact the quality of your decision making to reduce your risk and achieve regulatory compliance. With modules focused upon Software Quality, Design, Clinical, Quality Systems and Post Market Surveillance you can plan your quality and regulatory career by specific topic and subject. Routes available are:

PgCert – Medical Device QARA – Design Route PgCert – Medical Device QARA – Clinical Route

PgCert – Medical Device QARA – Quality Assurance Route PgCert – Medical Device QARA – Regulatory Route

Drivers to Your Education

Courses Modules Module Assessment Critical Evalua

tion

University Enrollment Professional Recognition University Accredita

tion Gradua tion Ceremon y W ork-Based

Assignments Academic Assessment

Knowledge & Competence

• Less time • More focused on ability to do the job • Professional recognition

4 4 4 ✖ ✖ 4 ✖ ✖ 4 ✖

Academic Recognition

• Academic • Research driven • Thought leading

• Address the University Diploma requirement in the EU regulation 4 4 4 4 4 4 4 4 ✖ 4

About our Education

The right people. The right solution. The first time.™

We Are

Different

but in a

Good Way

When you choose a course what do you really look for? • Content • Gain knowledge to apply • Recognition of competence • Career progression We have invested heavily in ensuring that all of our courses are relevant to the needs of the industry. We explain the ‘how’ rather than the ‘what’ which enables you to get on and plan, implement and succeed in your project activities. All knowledge we provide forms part of an overall professional recognition and career development framework regardless of your location. Full steam ahead or in your stride, study at the pace you or your company demands.

Module Certificates

Module certificates demonstrate a professional achievement in discrete areas of regulatory compliance. Our module certificates enable people working in Product Safety, Design, Clinical, Quality Engineering and Auditing functions to demonstrate that they have achieved a fundamental knowledge of the critical subjects involved in ensuring a safe and effective medical device.

Module Certificates we provide are:

Module 1: CE & Global Regulatory Professional

Module 2: Design, Risk and Safety Standards

Module 3: CE & Global Clinical Requirements

Module 4: Pre & Post Market Technical File Data

Module 5: Global Quality System Requirements

Module 6: CE Post Market & Vigilance

Module 7: Working with Regulatory Agencies

Module 8: The Professional Qualified Person

Module 9: Biological Evaluation and Test Methods

Module 10: Sterile Medical Devices Requirements

Module 11: Medical Device Auditing Professional

Module 12: Supplier Quality Professional

Module 13: Process Validation Professional

Association with Sheffield Hallam University

NSF Health Sciences has a highly successful track record for delivering quality training to both the medical device and pharmaceutical industries. We have implemented the first state of the art Medical Device Qualified Person (QP) program in collaboration with Sheffield Hallam University. All tutors are recognized subject matter experts.

The QA/RA environment is becoming increasingly complex. Recent EU legislation is advocating that industry has qualified QA/RA professionals in strategic roles. With this in mind NSF Health Sciences has developed a unique modular training program that will enhance the existing credentials of QA/RA professionals.

The QP program offers several training options provided at dedicated learning centres or, in-house.

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Module 1:

CE & Global Regulatory

Professional

2015 Regulatory Horizon – Medical Devices page 9 CE Marking Requirements for Medical Devices –

Complex Borderline and Class III Medical Devices page 11 CE Marking Requirements for Medical Devices –

Implementing page 11

CE Marking Requirements for Medical Devices – Understanding and Preparing for the

New EU Regulation page 12

Module 2:

Design, Risk and Safety

Standards

Implementing Design Control for Medical Devices page 17 Planning for Content Deviations in ISO 14971:2012 page 24 Risk Management for Software Based

Medical Devices page 28

Understanding Design Control for

Understanding Risk Management – ISO 14971 for

Understanding Standards for CE Marking of

Module 3:

CE & Global Clinical

Requirements

Medical Devices Clinical Evaluation –

Step by Step page 23

Planning and Conducting Clinical Investigations

for Medical Devices page 23

Post Market Clinical Follow Up for

Module 4:

Pre & Post Market Technical

File Data

CE Marking Medical Devices – Preparing and

Managing Technical Documentation page 10 The Design History File for Medical Devices page 31

Module 9:

Biological Evaluation and

Test Methods

2015 Product Safety Horizon – Medical Devices page 8 EN ISO 10993: Biological Evaluation of

Study Day Biological Evaluation and Product Safety for Complex Medical Technologies page 30 Undertaking Biological Evaluation for CE

Marking Step by Step page 35

Module 10:

Sterile Medical Devices

Requirements

Implementing the Requirements for Sterile

Sterilization Process Requirements for

Understanding the Requirements for Sterile

Module 11:

Medical Device Auditing

Professional

How to Audit Series – Advanced Audit

Techniques – Notified Body Auditing Techniques page 16 How to Audit Series – Medical Devices –

How to Audit Combination Products page 16 How to Audit Series – Medical Devices –

Advanced Auditing techniques page 17

Module 12:

Supplier Quality Professional

Implementing Supplier Control for Medical

Devices – CE Marking page 18

Understanding Supplier Control for Medical

Devices – CE Marking page 33

Module 13:

Process Validation

Professional

Process Validation for Medical Devices –

Planning and Conducting page 26

Module 5:

Global Quality System

Requirements

2015 Compliance Horizon – Medical Devices page 8 Implementing ISO 13485 – A Project

Management Approach page 18

Introduction to ISO 13485 page 19

ISO 13485 Advanced – Effective Change Control page 20 ISO 13485 Advanced – Effective CAPA

Investigations page 20

Module 6:

CE Post Market & Vigilance

Field Safety and Recalls for CE Marked

Post Market Surveillance Plans for CE Marked

Product Surveillance and Vigilance for CE

Marking of Medical Devices page 27

Module 7:

Working with Regulatory

Agencies

Pre Market Technical Briefings for

Regulatory Agency Enforcement & Remediation

for Medical Devices page 28

Structure of the Regulatory Agencies for

Module 8:

The Professional Qualified

Person

Communicating Quality and Regulatory Strategy to Senior Leaders and Investors for Medical

Device CE Marking page 13

Project Management for Medical Devices –

A Case Study Approach page 27

The Anticipated Role of the New Qualified Person

for Medical Device CE Marking page 30

Module 14:

Software Regulatory &

Quality

CE Marking for Medical Device Software –

Technical File and Quality System Requirements page 9 CE Marking Medical Device Software

Regulatory Requirements – Step by Step page 10 Clinical Evaluation of Medical Device Software

for CE Marking page 12

Current Approaches to CE Marking Software

(eHealth, Apps and Stand-Alone) page 14

Module 15:

IVD Regulations, Quality &

Product Safety

IVD CE Marking Regulatory Requirements –

Step by Step page 21

IVD CE Marking Standards, CTS and

Performance Evaluation page 21

IVD CE Marking Technical File Compilation &

Management page 22

IVD Clinical Data and Post Market

Surveillance Plans page 22

Planning for the Revision of the IVD Directive

98/79/EEC page 24

Module 16:

Combination Product

Requirements

Combination Product Risk Management and

Biological Evaluation – Key Issues page 13 Design Control for Combination Products page 14 Understanding Combination Product Regulations page 31 Understanding the Safety and Usefulness of a

Medicinal Substance for a Medical Device page 34

Module 17:

US Medical Device

Regulations

US Medical Device Regulations and Quality

System Compliance Series page 35

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A-Z

Training Courses

2015 Compliance Horizon –

Medical Devices

2015 Product Safety Horizon –

Medical Devices

2015 Regulatory Horizon –

Medical Devices

CE Marking for Medical Device

Software – Technical File and

Quality System Requirements

Module 5: Global Quality System Requirements Module 9: Biological Evaluation and Test Methods Module 1: CE & Global Regulatory Professional Module 14: Software Regulatory & Quality

About This Course

This will be a review of the EU notified body and FDA warning letters issued in 2014. We will explain the critical focus required to address these issues with your quality systems compliance plans.

Who Should Attend

If you are involved in quality systems and compliance and are working upon the development of your companies quality plan for 2015 you will find this course highly beneficial. Learning lessons from last year will enable you to put into the place the improvements needed to maintain a regulatory compliant quality system.

Your Tutors James Pink John Lang

About This Course

This will be a review of the issues surrounding the regulations globally that could affect medical devices. Certainly the European Medical Device and IVD regulations are being progressed well and therefore we will provide the necessary update so that people can plan within 2015.

For commercial, regulatory and quality professionals wishing to understand the impact of the medical device regulatory requirements primarily in Europe relating to medical devices and in-vitro medical devices. Professionals allied to the medical device industry such as legal and development consultants may find this overview extremely beneficial.

Your Tutors James Pink John Lang About This Course

A review of new risks new standards and new requirements impacting medical technology product safety in 2014. The course will provide specific risk management and product safety strategy required for an array of medical device technologies.

Who Should Attend

This course is essential for any professionals responsible for product safety within medical

devices. Development engineers, auditors and QARA professionals may also find the extensive background on biological safety a critical knowledge gap that this module will fulfill.

Your Tutors John Lang James Pink

About This Course

Two day course taking you through the specific expectations of software as a medical device including the technical file elements, validation methods and harmonized standards you will need to understand in order to demonstrate that your software fulfills the essential requirements in Europe. This course addresses the design control requirements often referred to as the software development lifecycle, as well as the quality management system specifics that most people unfamiliar with software quality assurance will need to know. The course explains the ‘what’ in terms of regulatory and quality system requirements and works hard on the ‘how’ by leaving you with simple project plans, checklists and draft procedures that you can adapt for your business. A truly practical ‘how to’ course. Who Should Attend

This course is also available in-house and recommended for:

• Medical Device Product Managers • Medical Device Product Designers • Medical Device Product Testers

• Medical Device Software Product Developers • Medical Device Quality Managers

• Medical Device Quality Engineers • Medical Device Regulatory Personnel Your Tutors James Pink Robert Cutts-Watson Date/s Location/s 21st January 2015 Sheffield/Webinar Date/s Location/s

11th-12th February 2015 AMP Sheffield 14th-15th July 2015 AMP Sheffield

Date/s Location/s

22nd January 2015 Sheffield/Webinar

Date/s Location/s

20th January 2015 Sheffield/Webinar

COURSE DURATION 1 day COURSE DURATION 1 day COURSE DURATION 1 day COURSE DURATION 2 days

I felt the NSF Tutor delivered the course excellently. My knowledge base was relatively zero entering the course and I feel all subjects were explained brilliantly. Darren Hall, Swann Morton

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A-Z

Training Courses

CE Marking Requirements for

Medical Devices – Complex

Borderline and Class III Medical

Devices

CE Marking Medical

Device Software Regulatory

Requirements – Step by Step

Medical Devices – Implementing

CE Marking Medical Devices –

Preparing and Managing

Technical Documentation

Module 1: CE & Global Regulatory Professional

Module 14: Software Regulatory & Quality Module 4: Pre & Post Market Technical File Data Module 1: CE & Global Regulatory Professional

About This Course

Class III and borderline medical devices falling under the medical devices CE marking regulatory requirements require a knowledge of a higher level of interaction with the notified body, competent authorities and other regulatory agency expert groups. From pre-clinical, clinical and regulatory specifics associated with Class III products we enable you to understand the specific regulatory hurdles that you need to clear prior to successful CE registration.

Specifically aimed towards quality and regulatory professionals responsible for the formulation of regulatory strategy and ensuring regulatory compliance of medical devices within Europe. For pharmaceutical QPs wishing to understand the regulatory requirements for medical devices including combination products.

CEOs and CTOs of new start-up business will find the modular and flexible delivery of this program of particular interest when formulating a regulatory project plan for their commercialization process. Your Tutors

Jonathan Hughes David Shea About This Course

One day course for people who need to understand the regulatory requirements for software as a medical device. This course will help you to determine how to effectively understand whether software is subjected to CE marking requirements. This is a practical case study driven training course which leaves you with no doubt as to how to approach explaining the commercialization risks associated with your software. Moreover, the day consists of project planning

sessions necessary to determine the pathway to conformity with CE requirements.

Who Should Attend

• Medical Device Quality Engineers • Medical Device Regulatory Personnel Your Tutors

James Pink

Robert Cutts-Watson

About This Course

A two day implementing course that will allow you to project manage the necessary processes, documentation and registration requirements for a CE marked medical device. Building upon the one day understanding course you will move into establishing the project management steps, milestones, procedures and regulatory interactions necessary to successfully coordinate a CE marking project.

Jonathan Hughes David Shea About This Course

A three day course aimed towards quality,

regulatory and product safety personnel involved in the pre-clinical, clinical, regulatory submission, on-market management and post on-market surveillance of medical devices. The course is biased towards European CE marking requirements for technical documentation but provides essential tips for the successful compilation of technical information such as scientific briefing documents,

pre-submission regulatory strategy and product safety summaries as well as the common expectations necessary for an EU technical file and Summary Technical Evaluation Document. If you need to generate a technical file for CE marking or global submissions then this is the course for you! Who Should Attend

Aimed at those who are involved in managing the submission of documentation to competent authorities, notified bodies and other interested agencies. Design, quality and regulatory professionals will benefit specifically from the best practices associated with the generation and management of technical documentation for pre-clinical, clinical investigation, submission and post-market development of technical data. Your Tutor

James Pink _Date/s _Location/s

21st May 2015 Manchester

24th September 2015 Manchester

Date/s Location/s

9th February 2015 AMP Sheffield 13th July 2015 AMP Sheffield

19th-20th May 2015 Manchester 22nd-23rd September 2015 Manchester

4th-6th February 2015 Manchester

COURSE DURATION 2 days

COURSE DURATION 3 days COURSE DURATION 1 day

COURSE DURATION 1 day

The NSF Tutor really knows his stuff, enjoyed working through MDD Found it really helpful.

Wilson Kennedy, Hospira

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A-Z

Training Courses

Combination Product Risk

Management and Biological

Evaluation – Key Issues

Medical Devices – Understanding

and Preparing for the New EU

Regulation

Communicating Quality and

Regulatory Strategy to Senior

Leaders and Investors for

Medical Device CE Marking

Clinical Evaluation of Medical

Device Software for CE Marking

Module 16: Combination Product Requirements

Module 1: CE & Global Regulatory Professional Module 14: Software Regulatory & Quality Module 8: The Professional Qualified Person

About This Course

A two day product safety course outlining the specific risks and expected controls for combination products. If you are involved in combination products, i.e. drug / device combinations, then you will be expected to demonstrate that you have taken into account the risks associated when the two entities combine. We explore typical aspects such as biocompatibility, drug efficacy, extractables and leachables as well as the subsequent expert opinion on expected controls. By the end of the course you should be able to prepare risk management documentation that is in line with regulatory agency expectations.

Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of combination products will benefit from this course.

Your Tutors John Lang James Pink About This Course

The regulatory requirements for medical devices are being revised under a new European medical device regulation. As many decisions are still to be taken this course aims to ensure that you are aware of the most robust and likely requirements to be implemented that have an impact upon your regulatory compliance and future regulatory strategy.

Who Should Attend

Jonathan Hughes David Shea

A one day course that addresses the techniques to adopt when speaking to senior leaders, investors and other non-technical interested parties about regulatory and compliance strategies. The course takes you through the current problem with communicating information to leadership teams and investors and enables you to adapt your messaging, presentation style, promises and handling expectations. We take you through how to handle the difficult situation of explaining why a product “will not be available in Europe in Q3!” by providing you with the necessary plans, decisions and tools necessary to ensure leadership understand the complexity and new pressures that exist within the European Medical Device regulatory framework. Who Should Attend

The module is aimed at quality and regulatory professionals wishing to build upon their technical skills and move into formal career development by discussing project management, management and presentation behaviors.

Your Tutor James Pink About This Course

One day course discussing the approaches required to obtain data demonstrating clinical efficacy and clinical benefit over risk in the area of clinical data. The course takes you through clinical investigation strategies, clinical evaluation methods and post market clinical follow-up specific to software based medical devices, in particular stand alone software.

Who Should Attend

• Medical Device Quality Engineers • Medical Device Regulatory Personnel Your Tutors James Pink Robert Cutts-Watson Date/s Location/s 28th-29th April 2015 Manchester/Webinar 16th-17th September 2015 Manchester/Webinar Date/s Location/s 18th May 2015 Manchester 21st September 2015 Manchester Date/s Location/s 24th June 2015 Manchester Date/s Location/s

16th July 2015 AMP Sheffield

COURSE DURATION 1 day COURSE DURATION 2 days

13 12

(8)

A-Z

Training Courses

EN ISO 10993: Biological

Evaluation of Medical Devices

Current Approaches to CE

Marking Software (eHealth, Apps

and Stand-Alone)

Field Safety and Recalls for CE

Marked Medical Devices

Design Control for Combination

Products

Module 9: Biological Evaluation and Test Methods

Module 14: Software Regulatory & Quality Module 16: Combination Product Requirements Module 6: CE Post Market & Vigilance

About This Course

A one day course aimed towards the requirements for biological evaluation of medical devices. The course identifies the essential principles of safety and performance around biocompatibility and provides you with the necessary ‘science’ to understand the fundamentals of bioactivity. Upon the review of biocompatibility requirements we then introduce you to the ISO 10993 series of standards, enabling you to understand exactly what they are and when to apply them.

This course is essential for any professionals responsible for product safety within medical

devices. Development engineers, auditors and QARA professionals may also find the extensive background on biological safety a critical knowledge gap that this module will fulfill.

Your Tutors John Lang Alastair Selby About This Course

A study day that brings together the leading regulatory, technical and product safety specialists in the field of software medical devices to discuss the specific trends associated with the CE marking of software. The study day addresses borderline issues such as eHealth and mobile health, discusses software applications and the regulatory options in Europe and brings together leading software quality engineering and cyber security experts to discuss the ongoing challenges of having a device that if hacked can potentially kill. The study day is a panel of experts brought together in an interactive learning environment whereupon you are afforded the opportunity to question, challenge and collaborate with the best in the business. Not to be missed!

Who Should Attend

This course is also available in house and recommended for:

• Medical Device Quality Engineers • Medical Device Regulatory Personnel Your Tutors

James Pink

Robert Cutts-Watson

About This Course

One day course for quality and regulatory compliance professionals involved in the management of the design of medical devices. This course will enable the delegate to understand the requirements for Design History (particularly from the US FDA CFR21 Part 820.30) and how to structure an effective DHF. Practical examples are based specifically around combination products, bearing in mind the recent introduction of CFR21 Part 4 – Combination product regulations.

Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of combination products will benefit from this course.

Your Tutors James Pink Beat Steffan

Date/s Location/s

11th May 2015 AMP Sheffield 2nd November 2015 Manchester

10th February 2015 AMP Sheffield

6th February 2015 Manchester

COURSE DURATION 1 day COURSE DURATION 1 day

A two day intensive course providing you with the tools necessary to effectively manage the critical aspects of field safety notifications, field safety updates and the specific requirements for withdrawing product from within Europe.

Providing simulations and scenarios the tutors will take you through the decision making processes, plans, risks and considerations to be made in order to manage patient safety, regulatory action and protect company reputation.

Starting with the basic requirements and common methods and then moving into communication

strategies, distribution considerations and supply-chain coordination, this course will enable you to manage some of the most complicated and stressful decisions you may experience in the marketplace. Forewarned is forearmed and this course will enable you to make realistic and valuable updates to your field safety and product recall processes.

Who Should Attend

Aimed at all professionals managing a medical device placed on the market and involved in any post market surveillance and vigilance, QMS feedback, clinical follow up and vigilance decision making activities. Authorized representatives and distributors will also find this module highly applicable to their function as critical operators within the supply and post market support of medical devices.

Your Tutor Jonathan Hughes Date/s Location/s 21st-22nd April 2015 London 15 14

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A-Z

Training Courses

How to Audit Series – Medical

Devices – Advanced Auditing

Techniques

How to Audit Series – Advanced

Audit Techniques – Notified Body

Auditing Techniques

Implementing Design Control for

Medical Devices

How to Audit Series – Medical

Devices – How to Audit

Combination Products

Module 11: Medical Device Auditing Professional

Module 11: Medical Device Auditing Professional Module 11: Medical Device Auditing Professional Module 2: Design, Risk and Safety Standards

About This Course

Auditing is a skill that requires fundamental knowledge and practice. This course takes you through the specific requirements for auditing as defined in ISO 19011 and, as it is medical device specific, identifies the specific behaviors, skills and audit planning necessary to be a successful medical device auditor. The course will provide you with an overview of FDA investigator training and EU notified body auditor training, as well as enable you to learn effective ways of quickly identifying non-compliance through active mentoring from some of Europe’s most experienced notified body auditors. We examine audit planning, conduct and non-compliance identification but concentrate upon audit trails, sampling and non-conformity identification. The course uses examples of medical device processes throughout, enabling you to address your internal auditor training needs.

Any professional with the responsibility for internal, supplier or third party audits where understanding the best practices for medical device auditing is crucial. This module establishes you as a thoroughly trained auditor in the field of medical device regulatory compliance. Pharmaceutical quality professionals now responsible for medical device organizations will benefit greatly from this course.

Your Tutors James Pink Henry Sibun About This Course

Notified body (NB) audits are under intense scrutiny from the European commission ever since the PIP incident. As a result we have prepared a course that enables you to understand the mindset of the notified body auditor, provides you with the tools and techniques adopted by notified body auditors so that you can adequately prepare your organization and for many ‘act’ and ‘simulate’ the notified body audit. We take you through the specific elements that NB auditors have been asked to concentrate upon during unannounced audits and enable you to pick up the ‘tricks of the trade’ in order to effectively audit like an NB.

Who Should Attend

Any professional with the responsibility for internal, supplier or third party audits where understanding the best practices for medical device auditing is crucial. This module establishes you as a thoroughly trained auditor in the field of medical device regulatory compliance. Pharmaceutical quality professionals now responsible for medical device organizations will benefit greatly from this course.

Your Tutors James Pink Henry Sibun

From a recent review of FDA warning letters, EU notified body assessments and the specific introduction of combination product regulations, it is clear that the concepts and techniques used in design control and risk management are still unclear to manufacturers wishing to implement, improve and maintain their development processes.

From understanding the requirements for combination product design and development processes subjected to CFR21 Part 4 and the typical requirements defined in CFR21 Part 820.30, ISO 13485 and the European Medical Devices Directives, the implementation course now goes through the specific changes you need to make to your Design plans, Design Input, Output and Design History documentation as well as your development processes and procedures in order to successfully implement compliant and effective design control. Who Should Attend

Development, regulatory and quality professionals responsible for design control and design transfer of medical devices. This course demonstrates your expertize to coordinate, plan and control the necessary elements of design quality to produce a safe and effective medical device. Pharmaceutical quality professionals responsible for development of combination products will benefit from completing this course as it covers all aspects of the design control and design transfer requirements within CFR21 Part 4.

Your Tutors James Pink Duncan Keeble Marcus Orton About This Course

This course is particularly biased towards medical device manufacturers that now face the likelihood of a GMP (pharma) based inspection or audit. The course is aimed to address the cross over between medical device and medicinal product regulations and enables traditional medical device auditors to understand the specific requirements for the active ingredient or specialist material that may be subjected to non-medical device regulation. From controls of raw materials, environmental and GMP expectations to the release of a combination product this course will certainly enable you to undertake audits in a way you would not have covered as a general medical device auditor.

Who Should Attend

Any professional with the responsibility for internal, supplier or third party audits where understanding the best practices for medical device auditing is crucial. This module establishes you as a thoroughly trained auditor in the field of medical device

regulatory compliance. Pharmaceutical quality professionals now responsible for medical device organizations will benefit greatly from this course. Your Tutors James Pink Henry Sibun Date/s Location/s 5th-6th May 2015 Manchester 9th-10th November 2015 Manchester Date/s Location/s 7th May 2015 Manchester 11th November 2015 Manchester Date/s Location/s Date/s Location/s 8th May 2015 Manchester 12th November 2015 Manchester

COURSE DURATION 1 day COURSE DURATION 2 days

17 16

(10)

A-Z

Training Courses

Implementing the Requirements

for Sterile Medical Devices

Implementing ISO 13485 – A

Project Management Approach

Implementing Supplier Control

for Medical Devices – CE Marking

Introduction to ISO 13485

Module 10: Sterile Medical Devices Requirements

Module 5: Global Quality System Requirements Module 12: Supplier Quality Professional Module 5: Global Quality System Requirements

About This Course

Two day course specifically looking at sterile medical devices, moving on from the basic requirements towards how to design appropriate environmental controls, cleanrooms, cleaning, packaging and sterilization processes necessary to achieve a ‘sterility assurance level’. The course examines the numerous harmonized standards and regulatory compliance expectations that you will need to address within your technical file, environmental monitoring program and quality management system. There are plenty of hints, tips, project plans and checklists to be able to navigate the maze of regulatory requirements concerning this area.

The course is designed for development engineers, manufacturing engineers, validation engineers, quality assurance and regulatory personnel involved in the design, validation and routine control of processes used during the manufacture of sterile medical devices.

Your Tutors Simon Richards Henry Sibun About This Course

A two day course identifying how to implement ISO 13845 from quality system documentation through to establishing the necessary procedures, records, reviews and processes. We outline the most effective way of implementing ISO 13485 and detail exactly how to project manage an implementation process that will be inspection ready. Full of practical examples, procedures, project plans and simple checklists, this course will enable you to implement the necessary requirements without the need for consultants!

Who Should Attend

Aimed towards professionals responsible for the development of quality management systems for medical devices. The course will certainly benefit new start-up companies as they will be able to implement a quality management system against the requirements of ISO 13485 and CFR21 part 820. Qualified Persons in pharmaceutical manufacturers will find this course highly beneficial if they are working with a new division providing a medical device or if they need to work with a supplier based upon implementation of an effective QMS.

Whether you are working toward the registration of your first CE marked product or you are wanting to diversify into the medical device supply chain, ISO 13485 is the standard required for all regulatory aspects associated with your processes. This course takes you through how to plan and execute an implementation project, enabling you to walk away understanding exactly what needs to be done and how to successfully implement ISO 13485 within your organization.

Who Should Attend

Your Tutors James Pink Henry Sibun About This Course

This two day course has been developed to build upon the Understanding course and enable you to develop appropriate purchasing requirements, supplier evaluation and selection methods necessary to demonstrate effective control over the supply chain. Concentrating upon the establishment of quality and technical agreements, the course outlines the importance of supplier evaluation and re-evaluation and provides a solid basis for establishing robust procedures in the field of supplier control.

If you are working with critical suppliers and sub-contractors this course is one of a kind in that it provides you with the necessary requirements for how to suitably select, specify, qualify and monitor the supply chain. If you are a virtual manufacturer you will find this course particularly useful.

Your Tutor James Pink Date/s Location/s 3rd-4th March 2015 Manchester Date/s Location/s 17th-18th March 2015 Manchester 6th-7th October 2015 Manchester Date/s Location/s 16th March 2015 Manchester 5th October 2015 Manchester Date/s Location/s

21st-22nd July 2015 AMP Sheffield

COURSE DURATION 2 days COURSE DURATION 2 days

Very informative course , the discussion on auditing approach – effectiveness US compliance – very good

Gareth Quinn, Baxter

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Training Courses

ISO 13485 Advanced – Effective

Change Control

ISO 13485 Advanced – Effective

CAPA Investigations

IVD CE Marking Regulatory

Requirements – Step by Step

Module 5: Global Quality System Requirements Module 5: Global Quality System Requirements Module 15: IVD Regulations, Quality & Product Safety

About This Course

The largest risk to your medical device product safety is the constant change that your organization has to make! This course outlines the requirements for change control and provides a critical insight into how to manage change control, from basic design control through to changes within personnel.

About This Course

One day course aimed towards ensuring that those personnel bringing a IVDD into the market (Europe) are aware of the requirements. The course also enables regulatory and quality personnel to plan the impact of the new directive scheduled to come into force in Q4 2015.

Who Should Attend • Senior management

• Regulatory, quality, research, design, development, manufacturing, marketing managers and personnel • Organizations preparing ‘own brand’ or ‘private

label’ devices • Distributors of IVDs Your Tutor

Sarah Couch About This Course

In order to undertake corrective and preventive action effectively there is a need to understand exactly what constitutes good practice. This course is aimed towards helping you to identify CAPA opportunities and takes you through how to effectively investigate using the information and tools available within your organization. As a medical device manufacturer it is critical that CAPA is effective and it is a common expectation by regulatory agencies that this is one of the most robust processes within your organization. Learn how to manage CAPA effectively, from identifying and managing sources of CAPA to the effective

implementation of corrective actions. Who Should Attend

Your Tutors James Pink Henry Sibun Date/s Location/s 19th March 2015 Manchester 8th October 2015 Manchester Date/s Location/s 28th January 2015 Manchester 24th March 2015 AMP Sheffield 20th October 2015 Manchester

Date/s Location/s

20th March 2015 Manchester 9th October 2015 Manchester

IVD CE Marking Standards, CTS

and Performance Evaluation

Module 15: IVD Regulations, Quality & Product Safety

About This Course

One day course outlining diagnostic utility and performance evaluation for IVDs. The course aims to bring you up to speed with the latest product safety activities required by the IVD Directive to address essential safety and performance requirements. Who Should Attend

• Senior management

label’ devices • Distributors of IVDs Your Tutors Sarah Couch James Pink John Lang Date/s Location/s 30th January 2015 Manchester 26th March 2015 AMP Sheffield

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Training Courses

IVD Clinical Data and Post

Market Surveillance Plans

Medical Devices Clinical

Evaluation – Step by Step

IVD CE Marking Technical File

Compilation & Management

Module 15: IVD Regulations, Quality & Product Safety Module 3: CE & Global Clinical Requirements Module 15: IVD Regulations, Quality & Product Safety

About This Course

With changes to IVD regulation in Europe it will

become more evident that IVD manufacturers will need to have robust PMS and clinical data. The methods of planning, conducting and documenting clinical data for IVDs are certainly different to general medical technologies; hence this course takes you through the best practices within this area. Full of examples, plans and solutions you will find this course of value if you are preparing for the changes.

Sarah Couch

About This Course

Learn how to undertake a critical review of scientific and clinical data in order to present a robust clinical evaluation of your device technology’s clinical performance. This course will enable you to understand the disciplined approach required to meet the requirements for clinical evaluation defined within 93/42/EEC Annex X and identify when clinical data is sufficient and not sufficient to support your medical device.

Development, regulatory and clinical personnel involved in the formulation of clinical investigations, evaluations and post market clinical follow-up of medical devices. The medical devices requirements are placing a major emphasis upon clinical data requirements for devices, therefore programme managers, marketing and senior managers will also benefit from this module in that they will be able to understand the clinical requirements necessary for their devices and plan an appropriate commercialization strategy.

Your Tutors

Rikke Arendt Christiansen Alastair Selby

John Lang About This Course

One of the major aspects of CE marking for IVDs is the compilation and management of appropriate technical documentation. This course takes you through the requirements for IVD technical files, outlines common technical specification, harmonized standards and the best practices adopted for maintaining appropriate compliant technical files.

label’ devices • Distributors of IVDs Your Tutor Sarah Couch Date/s Location/s 22nd October 2015 Manchester Date/s Location/s 10th-11th February 2015 Manchester 14th-15th July 2015 AMP Sheffield 24th-25th November 2015 Manchester

Date/s Location/s

29th January 2015 Manchester 25th March 2015 AMP Sheffield 21st October 2015 Manchester

Planning and Conducting

Clinical Investigations for

Medical Devices

Module 3: CE & Global Clinical Requirements

About This Course

From establishing what should be within the clinical study protocol to understanding the actual stages for applying for Clinical Investigation with European Competent authorities, this course will enable you to understand the decision making and practical aspects concerning EU Clinical Investigations.

Development, regulatory and clinical personnel involved in the formulation of clinical investigations, evaluations and post market clinical follow-up of medical devices. The medical devices requirements are placing a major emphasis upon clinical data requirements for devices, therefore programme managers, marketing and senior managers will also benefit from this module in that they will be able to understand the clinical requirements necessary for their devices and plan an appropriate commercialization strategy.

Your Tutors

John Lang

Date/s Location/s

9th February 2015 Manchester 13th July 2015 AMP Sheffield 23rd November 2015 Manchester

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Training Courses

Planning for the Revision of the

IVD Directive 98/79/EEC

Post Market Clinical Follow Up for

Medical Devices

Planning for Content Deviations

in ISO 14971:2012

Module 15: IVD Regulations, Quality & Product Safety Module 3: CE & Global Clinical Requirements Module 2: Design, Risk and Safety Standards

About This Course

A one day course aimed towards enabling people involved in IVD regulatory to understand the impact of the regulation and ensure an appropriate plan is in place to address the new requirements in 2015. This course will be particularly appealing to those personnel responsible for the commercial planning of products set to fall under the new IVD Directive.

Sarah Couch

About This Course

Within the European medical device directives there are specific requirements for obtaining post-market data relating to the clinical performance of your product utilizing a post market clinical follow-up plan. This course presents the requirements for PMCF and will enable you to understand the requirements and apply them to your internal procedures.

Development, regulatory and clinical personnel involved in the formulation of clinical investigations, evaluations and post market clinical follow-up of medical devices. The medical devices requirements are placing a major emphasis upon clinical data requirements for devices therefore programme managers, marketing and senior managers will also benefit from this module in that they will be able to understand the clinical requirements necessary for their devices and plan an appropriate commercialization strategy.

Your Tutors

John Lang About This Course

A one day course specifically dedicated towards managing the additional focus from notified bodies and EU regulatory agencies associated to the content deviations within ISO 14971. We discuss the background to the deviation and identify the specific elements in your risk management documentation that need to be reviewed and addressed in order not to fall foul of the content deviations. A practical and informative course that will enable you to review your current approach to risk management and compare it with the expectations of your notified body.

Who Should Attend

Development, regulatory, quality and product safety professionals responsible for the coordination of risk management activities. Your Tutors James Pink Duncan Keeble Marcus Orton Date/s Location/s 27th January 2015 Manchester 23rd March 2015 AMP Sheffield 19th October 2015 Manchester

12th-13th February 2015 Manchester 16th-17th July 2015 AMP Sheffield 26th-27th November 2015 Manchester

22nd October 2015 Manchester

Post Market Surveillance Plans for

CE Marked Medical Devices

Module 6: CE Post Market & Vigilance

About This Course

Unless you have been in a land far-far away you will be aware of the additional scrutiny of CE marked products and in particular the methods of adopting appropriate product surveillance plans and subsequent data analysis in order to provide early warning of product safety and quality issues. This course takes you through the notified body and competent authority expectations for post market surveillance and applies a case study approach for a series of different types of devices including the obvious implantable products but also covering wound-care, infusion pumps, electro-medical diagnostic devices and single use instruments.

Moving from the basic regulatory requirements to establishing best in class trending data from internal and external sources, we will equip you with the necessary insight towards adopting a fit-for-purpose post market surveillance plan and introduce you to the necessary quality management system procedures, data collection methods and state-of-the-art methods to maintain a robust, cost-effective and highly informative analysis that will inform your regulatory compliance.

Your Tutor Jonathan Hughes

Date/s Location/s

23rd-24th April 2015 London

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Training Courses

Process Validation for Medical

Devices – Planning and

Conducting

Product Surveillance and

Vigilance for CE Marking of

Medical Devices

Pre Market Technical Briefings for

Medical Devices

Module 13: Process Validation Professional Module 6: CE Post Market & Vigilance Module 7: Working with Regulatory Agencies

About This Course

A highly interactive course. The first day starts you off with the requirements for process validation and looks at various guidance from the FDA / IMDRF / Harmonized standards and GAMP to extract the basic principles of process validation. Building on from the basic requirements we examine the techniques of understanding the product specification, integrating risk management activities and setting the course for the validation activity. From validation master planning to setting up the validation study, this is a course specifically aimed at professionals who need to get on and manage highly complex validations. We bring together the statistics, engineering study and regulatory science coupled with quality assurance principles in order to ensure that you can leave feeling in charge of your next validation project.

Any professional in a development, manufacturing engineering, quality assurance or supplier background where processes require validation. This course enables you to plan, implement and manage validation projects that are regulatory compliant. If you are a pharmaceutical quality professional you will find this course particularly interesting if you need to understand the differences between pharmaceutical and medical device process validation approaches. Your Tutors

James Pink Chris Harris

About This Course

This one day interactive course provides you with the simulated practices for interpreting adverse events and product quality trends in order to determine if vigilance action and reporting are required.

Understanding whether adverse information requires vigilance action can often be more complicated than the basic requirements infer. In particular we cover the issues of understanding whether the product contributed to the adverse event, and the potential difference in interpretation from EU competent authorities.

Within the course we examine periodic reporting, utilizing risk management as a means of informing vigilance action to regulatory agencies, and look at the potential impact of the EUDAMED database on the registration and sharing of data between agencies.

Your Tutor Jonathan Hughes About This Course

A two day course aimed towards medical device manufacturers or manufacturers unsure of the appropriate regulatory classification. This course has been developed in order to help you understand the regulatory agencies involved in formulating a medical device classification when it is extremely complex, novel or has borderline properties. The course helps you to prepare technical information in a way that can be presented to regulatory agencies so that you can achieve definitive responses as to the classification, conformity assessment route and need for pre-clinical and clinical data. The course begins by describing the importance of the product description, intended use and principal mode of action. From determining who to contact in what agency through to simple tips for managing the briefing, you will find this course invaluable if you wish to carve out a career in advanced regulatory, quality or product safety in healthcare technology products.

Who Should Attend

The course is aimed at personnel within the

organization involved specifically with scientific and / or regulatory affairs strategic planning and regulatory enforcement. In a world where regulatory scrutiny has increased several-fold it is crucial that professionals are capable of communicating effectively with their regulatory agency at pre-clinical, pre-submission, submission and regulatory enforcement phases. The course also provides excellent guidance upon responding to regulatory agencies during times of business critical enforcement.

Your Tutor

James Pink Date/s_{7th-9th July 2015} Location/s_{AMP Sheffield}

Date/s Location/s

20th April 2015 London

12th-13th May 2015 Manchester

COURSE DURATION 2 days COURSE DURATION 3 days

Project Management for

Medical Devices – A Case Study

Approach

Module 8: The Professional Qualified Person

About This Course

A one day course that provides you with an overview of the typical project planning activities that regulatory compliance specialists (regulatory / quality / product safety) may encounter. We critically evaluate project management principles and outline the key project plans that you may be involved in realizing, from CE marking step by step, process validation planning through to planning a change of notified body. The course is highly interactive and you get from it what you put into it. The course tutors are skilled in establishing and documenting project plans in a regulated

environment and you will learn a lot more than you first may think in this area!

The module is aimed at quality and regulatory professionals wishing to build upon their technical skills and move into formal career development by discussing project management, management and presentation behaviors. Your Tutors James Pink Marcus Orton Date/s Location/s 25th June 2015 Manchester

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Training Courses

Risk Management for Software

Based Medical Devices

Sterilization Process

Requirements for Medical

Devices

Regulatory Agency Enforcement

& Remediation for Medical

Devices

Module 2: Design, Risk and Safety Standards Module 10: Sterile Medical Devices Requirements Module 7: Working with Regulatory Agencies

About This Course

A one day course aimed towards the risk management and controls necessary for software based medical devices. This course provides practical guidance as to the harms, hazards and hazardous situations that software based devices may encounter. The course takes into account the most recent public health scares associated with cyber security and the potential hacking of implantable medical devices, infusion systems and patient data associated with diagnostic devices. We examine the state of the art approaches to controlling these risks and have information security and software engineering expertize to outline how a high degree of protection is established for software systems. Who Should Attend

Regulatory compliance professionals responsible for software based devices.

Development and risk management experts new to software risk.

Your Tutors James Pink

Robert Cutts-Watson Duncan Keeble

About This Course

Sterilization processes such as ETO, Gamma and Steam require detailed knowledge of the fundamental science, validation methods and the risks associated with poor understanding by personnel working with critical sub-contractors and process engineers in this area. This course will not ever claim to turn you into an expert in this area; however it will certainly arm you with the necessary fundamental understanding to challenge your approaches and implement essential controls over your suppliers, within your own processes and make informed decisions associated with changes in sterilization process parameters, loads or cycles. Who Should Attend

The course is designed for development engineers, manufacturing engineers, validation engineers, quality assurance and regulatory personnel involved in the design, validation and routine control of processes used during the manufacture of sterile medical devices.

Your Tutors Simon Richards Henry Sibun About This Course

A two day course aimed towards medical device manufacturers that are actually or potentially in regulatory enforcement proceedings. The course takes you through how regulatory enforcement action is taken, from the simple generation of a quality system or technical file non-conformity to a whole scale multi competent authority lead safeguarding action. This two day course takes you through the necessary skills, report writing, coordination, project planning and legal interactions necessary to effectively address regulatory

enforcement and also outlines in no uncertain terms the effects and likely impacts that can be expected when regulatory enforcement ensues. The course provides you with specific guidance as to how to work with and respond to regulatory agencies including notified bodies, Competent Authorities and European Commission agencies in the light of regulatory action.

Who Should Attend

organization involved specifically with scientific and / or regulatory affairs strategic planning and regulatory enforcement. In a world where regulatory scrutiny has increased several-fold it is crucial that professionals are capable of communicating effectively with their regulatory agency at pre-clinical, pre-submission, submission and regulatory enforcement phases. The course also provides excellent guidance upon responding to regulatory agencies during times of business critical enforcement.

Your Tutor James Pink Date/s Location/s 17th April 2015 Manchester 23rd October 2015 Manchester Date/s Location/s 5th-6th March 2015 Manchester Date/s Location/s

COURSE DURATION 2 days COURSE DURATION 1 day

Structure of the Regulatory

Agencies for Medical Devices

Module 7: Working with Regulatory Agencies

About This Course

A one day course aimed towards outlining the structure of regulatory agencies and the allied agencies involved in ensuring public health and safety is addressed within medical devices. This course focuses specifically upon the European regulatory agencies, expert groups and notified body coordination groups, providing you with essential intelligence as to how Europe really establishes regulatory oversight. If you are familiar with the medical devices, directives in Europe you will find this course absolutely essential to your future in medical devices as it demystifies how medical device legal, product safety and regulatory oversight is truly shaped and the bodies that come together to shape it. Who Should Attend

organization involved specifically with scientific and / or regulatory affairs strategic planning and regulatory enforcement. In a world where regulatory scrutiny has increased several-fold it is crucial that professionals are capable of communicating effectively with their regulatory agency both at pre-clinical, pre-submission, submission and regulatory enforcement phases. The course also provides excellent guidance upon responding to regulatory agencies during times of business critical enforcement.

Your Tutor Jam