3:15 Networking and Refreshment Break. 3:45 Cloud Computing Manage Risk in a

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12:15

Conference Registration

1:15

Conference Chairperson’s Welcome and

Opening Remarks

Deborah S. Turner, Associate Director, Computer and Automation Validation, Alkermes plc

1:30

Celebrating 30 Years of Computer Validation Trends,

Regulations and Directives

The FDA published its first guidance for inspection of computer systems used in pharmaceutical manufacturing in February 1983. It was “fondly” called the “Blue Book” due to the color of its cover. We are now in 2013 and the use of computer technology has changed profoundly over the past 30 years. Many more regulations and guidances have been developed by authorities around the world and changes like cloud technology continue to expand the horizons of technology and compliance directives. In this presentation, an eyewitness to the 30 year progression shares insights and analysis of the advances made by the industry, technology and the authorities and discusses common themes across all legislative requirements. Reviewing history can help us understand the context for today’s computer validation practices and regulatory conditions. It is not all madness, there really is a method to it. Attendees in this session learn: t 5IFMPHJDBMQSPHSFTTJPOPGDPNQVUFSSFHVMBUJPOTBT

authorities attempted to keep up with technology trends over the past 30 years

t 5IFDPNNPOUIFNFTBDSPTTBMMSFHVMBUJPOTBOEEJSFDUJWFT Then and now

t "QSBDUJDBMFYFSDJTFGPSUSBJOJOHFNQMPZFFTPOSFHVMBUJPOT and directives in an engaging manner

t "HMPCBMQFSTQFDUJWFPODPNQVUFSWBMJEBUJPOUPEBZ Teri Stokes, Ph.D., Director, GXP International

2:15

Computer System Validation Then and Now —

Learning Management in the Cloud

Non GMP cloud-based HR systems have been available for many years. This session looks at B. Braun’s journey in moving from an in-house validated training tracking system to learning management in the cloud.

t 4ZTUFNTUSBUFHJFTBOEXIZ##SBVOEFDJEFEUPNPWFUP the cloud t 7BMJEBUJPOQSPDFTTGPS##SBVOTJOUFSOBMUSBJOJOH tracking system t ,FZDPODFSOTPGVTJOH-FBSOJOH.BOBHFNFOU4ZTUFNT -.4JOUIFDMPVEBOEUIFTUFQTUBLFOUPNJUJHBUFSJTL t &YQFDUFEDVSSFOUWBMJEBUJPOQSPDFTTPGPVSDMPVECBTFE-.4 Dennis Houser, BSIE, MBA, PMP, Director, Corporate HR Systems & Payroll, B. Braun Medical Inc.

Heather Carrillo, MBA, PMP, HRIS Analyst, B. Braun Medical Inc.

3:15

Networking and Refreshment Break

3:45

Cloud Computing — Manage Risk in a

Regulated Environment

Many life sciences companies are wary of moving applications into a cloud-based model, as it is not immediately clear how the risks associated with this technology can be assessed, let alone managed. This presentation shows that with an understanding of the different variants of cloud architecture, and a provider that understands the life sciences industry, understanding and managing the risks is relatively straightforward.

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Business & Decision North America

4:30

Recent CSV Enforcement — Learn from Trends and

Proactively Avoid Part 11 Citations

Translating regulatory and guidance documents into a SPCVTU$47QSPHSBNUIBUTUBOETVQUPUIFTDSVUJOZPGBO '%"JOTQFDUPSDBOCFEBVOUJOH,OPXJOHXIBUSFHVMBUPSZ JOTQFDUPSTBSFMPPLJOHGPS BOETPNFUJNFTOPUGJOEJOH during their inspections can be a valuable tool. This session provides an in-depth, practical look at:

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t 4FMGBVEJUJOHQSPHSBNTUIBUXPSL Wen Wang, Senior Validation Engineer, Genoptix 5:15

Write Effective Software Requirement

Specifications

The output of any software validation project depends on the quality of the requirements. Frequently, software requirement specifications are poorly written, which can lead to significant rework costs and project delays. This presentation provides a comprehensive overview of how to write software requirements that meet quality standards. t 5IFJNQPSUBODFPGXSJUJOHHPPESFRVJSFNFOUT t $IBSBDUFSJTUJDTPGRVBMJUZSFRVJSFNFOUTUBUFNFOUT t 3FRVJSFNFOUTRVBMJUZJOEJDBUPST

t (FOFSBMHVJEFMJOFTGPSXSJUJOHHPPESFRVJSFNFOUT Gregory W. Pierce, President, EngiSystems Software Validation 6:00

Close of Day One

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There will be a 30-minute networking and refreshment break at 10:15

In this closed-door summit, senior-level computer validation and quality managers from pharmaceutical, biotech and medical device companies engage in open discussion with their colleagues about strategies for managing their most pressing challenges. The content for this summit is

driven by the participants who are surveyed ahead of time about the topics they wish to discuss. This session is open to the first twenty senior-level professionals who pre-register for the interactive discussion group. In order to pre-register, you must have more UIBOZFBSTPGFYQFSJFODFJO$47FYFDVUJPO

and currently work for a pharmaceutical, medical device or biotech company. IVT reserves the right to qualify participants for the workshop.

Deborah S. Turner, Associate Director, Computer and Automation Validation, Alkermes plc

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7:15

Continental Breakfast

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I.

Review Traditional Disaster

Recovery (DR) and

Business Continuity (BC)

Activities

a. Plan for disasters

b. Take stock – system inventory c. Identify roles and

responsibilities d. Account for logistical

problems

e. Test and verify the plan f. Consider managed services

II.

You and Your Team

g. Institute high availability I 7JSUVBMJ[FUIFDPNQVUJOH

environment

J ,FFQJUPOMJOF– network storage

III.

Consider Hosted and

Cloud-Based Services

a. Identify impacts b Mitigate the risks c. Adjust the approach

IV.

Interactive Session

Participants discuss aspects of disaster recovery and business continuity for a case study involving internally and externally hosted applications Mike Byrd, Director of CSV,

ProPharma Group, Inc

The objective of this workshop is to gain a solid understanding of risk management definitions, concepts and techniques. You discuss how these can be applied to the development and validation of computer systems.

I.

What Is Risk Management?

t 6OEFSTUBOEUIFEFGJOJUJPOPG risk in order to better apply risk management

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concepts and techniques to computer system development and validation II.

Risk Assessment Tools

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assessment tool

III.

Risk Management Applied to Right

Sizing Your Computer Validation

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mitigate risk

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and risk considerations provided to determine how to apply a SJHIUTJ[FE$47BQQSPBDI IV.

Interactive Exercise #1

During this first interactive exercise, BUUFOEFFTQBSUJDJQBUFBTBO4.&POB

1)"'.&"SJTLBTTFTTNFOU-FBSOXIBU JUUBLFTUPQFSGPSNB1)"'.&"SJTL assessment as well as some key risk assessment facilitations skills. V.

Interactive Exercise #2

During this interactive exercise, attendees sit on a panel and discuss how known risks may influence how a computer system is validated. A mock computer system is presented along with some outcomes of risk assessments. Based on this information, participants share with the session facilitator and other members of the workshop how an example computer system’s validation plan may be shaped by risk management.

Dennis J. Caron, Associate Director, IT Computer Systems Validation (CSV), Covance Inc. Michael Osburn, Associate Director, IT Computer Systems Validation (CSV), Covance Inc.

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I. What do the Requirements Mean? t $MPTFMPPLBU$'31BSU t 3FWJFXPG"OOFY t %FGJOJUJPOTPG&MFDUSPOJD3FDPSET &MFDUSPOJD4JHOBUVSFT &3&4 t $POTFRVFODFTPGOPUGPMMPXJOH regulations

II. How to Demonstrate Compliance t 1VUQSPDFEVSFTJOQMBDF t %FWFMPQBO&3&4(Y1 assessment questionnaire t 5FTUFMFDUSPOJD records functionality t 5FTUFMFDUSPOJD signature functionality

III. Interactive Exercise

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Matthew Poeta, Senior Technologist, IT Compliance, Genzyme (a Sanoﬁ Company)

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II. Techniques to Properly Validate Spreadsheets t 7FSJGZGPSNVMBTBOEGVODUJPOT t 6TFMFBOWBMJEBUJPOUFDIOJRVFTUPTQFFE things up t -FBSOIPXUPQSPQFSMZVTFQSPUFDUJPOJO &YDFM t 4IBSFMFTTPOTXFIBWFMFBSOFE

III. Interactive Exercise

Attendees select a small spreadsheet with some tough challenges to demonstrate how to handle each case quickly, efficiently and effectively. Attendees also have the opportunity to download some sample templates of both spreadsheets and the validation documents that go with them.

Ty Mew, President, Ofni Systems

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I.

What are the Business

Advantages of Master Data

Management (MDM)?

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II.

Qualify or Validate MDM

systems and Data Services?

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qualification and validation III.

Validate Data Services against

MDM Standards

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IV.

Interactive Exercise — Develop

a MDM Validation Strategy

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David Hawley, Director,

Business & Decision Life Sciences

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1

In this interactive workshop, attendees explore the various types of cloud services, learn how each might be leveraged to support GxP systems and understand the measures that need to be taken to minimize risk and ensure compliance.

I.

Cloud Computing Paradigms

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t $MPVETFSWJDFNPEFMTBOECFTUVTF cases for each

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II.

Elements of a Cloud

Compliance Framework

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III.

Qualification and Validation of a

Cloud Computing Platform

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IV.

Interactive Exercise #1

Attendees work through case studies to develop a framework for planning, executing and controlling company assets in a cloud computing environment.

V.

Interactive Exercise #2

Attendees are asked to bring their current cloud computing questions and challenges. Workshop leaders plan to select several challenges and work as a group to identify potential solutions using key concepts from the session. Colleen Turner, Director, IT Validation Services, Bristol-Myers Squibb

Colleen Harney, Associate Director, IT Validation Services, Bristol-Myers Squibb

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In this i

(4)

I. The Purpose of a Master Plan for Computer Validation t )PXEPFTJUEJGGFSGSPN7.1BOE71 t )PXDBOJUSFEVDFUIFEPDVNFOUMPBE II. Roles for System Teams,

Sponsors, and Quality

III. Elements of a Master Validation Plan for Computer Validation

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t 'MFYJCMFVTFT IV. Interactive Case Work

t 6TFEPDVNFOUTGSPNBSFBMQSPKFDUUP TFFIPXUPEFWFMPQB.BTUFS1MBO.JOJ Form approach to computer validation is a regulated environment

Bonus Material: Chapter 6 from new book

Computer Validation: A Common Sense Guide

by Dr. Teri Stokes. Book available at Amazon.com Teri Stokes Ph.D., Director,

GXP International %&7&-01"$0.13&)&/4*7&."45&31-"/'03$0.165&37"-*%"5*0/*/"3&(6-"5&%&/7*30/.&/5 % % % %

5

 / F U X P S L J O H B O E 3 F G S F T I N F O U # S F B L

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I. Why Create and Execute Protocol Test Plans/Scripts? t 7FSJGZUIBU6TFS3FRVJSFNFOUTIBWF been met t %FNPOTUSBUFUIBUUIFTZTUFNJTGJUGPS use t 4BUJTGZSFHVMBUPSZSFRVJSFNFOUT II. How Do We Know What to Test?

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IV. Interactive Exercise 6TJOHBSFBMMJGFFYBNQMF participants develop a test script for a new software application based on user requirements. The participants execute the test script BOEEPDVNFOUSFTPMWFBOZOPO DPOGPSNBODFTJODJEFOUT

Matthew Poeta, Senior Technologist, IT Compliance, Genzyme (a Sanoﬁ Company)

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4

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I.

Develop Human-Based/

Static Testing Strategies

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functional testing

II.

Develop Test Scenarios

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t $POTJEFSCSBODIJOH EFDJTJPO tables, etc.

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Analyze Testing

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IV.

Interactive Exercise

Participants examine and discuss testing strategies that go beyond executing test scripts to identify system deficiencies. Attendees look at ways to identify issues before the first line of code is created. Mark Cole, Deputy Director, IS Quality, Compliance and Security, Sanoﬁ Pasteur

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7

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I.

Introduction to

Process Measurement

t 8IZNFBTVSF t 8IBUUPNFBTVSF * software quality * compliance to external regulations, standards and guidance * consistency of process execution * efficiency

II.

Explore Various

Measurement Methodologies

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III.

Evaluate and Act on

Measurement Results

IV.

Interactive Exercise

Participants develop a measurement program for a spreadsheet validation process.

Joseph Zec, Software Quality Senior Manager, Quality & Regulatory, Philips Health Care

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I

9

I.

Mobility

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II.

Validation Approach

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III.

Interactive Exercise

6TJOHBSFBMMJGFFYBNQMFQBSUJDJQBOUT look at the challenges presented by the use of mobile applications to conduct activities required by the 2VBMJUZ4ZTUFN3FHVMBUJPOT Michael Romeu-Lugo, CISA, Global IT Senior Manager, Quality and Compliance, Teleﬂex Incorporated

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I

M

10

I.

Select the Right System

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II.

Vendor Validation Packages

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III.

Level Set Your Validation Effort

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IV.

Change Management

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Interactive Exercise

2VFTUJPOBOEBOTXFSTFTTJPO Deborah S. Turner, Associate Director, Validation, Alkermes plc

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I

S

11

 / F U X P S L J O H - V O D I F P O

I.

Purpose of the CSV Periodic

Review (PR)

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II.

What to Review

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adjustment to the computer system access

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Report of PR

IV.

Remediation

Yau Kai Wong, Associate Director, QA Validation, Novartis Pharmaceuticals Corporation

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THE TIMING AND THE INFORMATION THAT IS REVIEWED

I

P

8

(6)

**C H O O S E F R O M 5 ) 3 & & . * / 6 5 & 4 & 4 4 * 0 / 4 **

I.

Define the Purpose,

Scope and Structure of

an Electronic Archive

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and why is backup media not an FMFDUSPOJDBSDIJWF

t 8IBUJTUIF0&$%HVJEBODF approach to archiving and FMFDUSPOJDBSDIJWFT

t "OBMZTJTPG401UPQJDTGSPN0&$% for establishing an archive II.

Archiving Principles, Archivist

Values and The Electronic

Document Difference

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indexing and catalogue

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a long term retention requirements specification III.

Interactive Exercise

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Bonus Material:

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Cooperation and Development 0&$%(VJEBODF i&TUBCMJTINFOUBOE$POUSPMPG Archives that Operate in Compliance XJUIUIF1SJODJQMFTPG(-1w

Teri Stokes, Ph.D., Director, GXP International

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I.

Define “Validation Type”

and Applicability

t 6OEFSTUBOERVBMJGJDBUJPO vs. validation

* infrastructure * applications

* plant floor manufacturing equipment

* regulatory applicability

II.

Interpret the Key Principles

and Processes of ISPE’s

GAMP 5

™

_{and ASTM E 2500}

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III.

Implementation of Your

Validation Program — What Are

the Required Elements?

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Bonus Information

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Judith Samardelis, Senior Manager, IS Compliance and Quality Release, MedImmune

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I.

Social Media and The Life

Sciences Industry

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II.

Social Media ≠ Labeling

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Interactive Exercise

Attendees review a social media proposal, identify its risks and propose the controls to address them.

Michael Romeu-Lugo, CISA, Global IT Senior Manager, Quality and Compliance, Teleﬂex Incorporated

Dan Callari, Senior Customer Facing Manager, Teleﬂex Incorporated

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14

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A G R E A T P L A C E T O M E E T Y O U R M A R K E T

Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while

demonstrating thought leadership and sharing expertise. For more information on how to position your

company as a sponsor or exhibitor, contact Taylor Biggers at 339-298-2108

or email [email protected].

C O N F E R E N C E S P O N S O R S

Delivering Excellence

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I.

Requirements

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Audit

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Testing

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IV.

Change Management

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V.

Interactive Exercise

Participants discuss current concerns XJUI4BB4WFOEPSTBOEUFDIOJRVFTUP help compliantly manage them. Deborah S. Turner, Associate Director Validation, Alkermes plc

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15

I.

Purpose of Audit

II.

How to Select an Appropriate

Cloud Service Provider

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about the cloud

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III.

Audit Process

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Yau Kai Wong, Associate Director, QA Validation, Novartis Pharmaceuticals Corporation

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16

I.

Characterize CSV

Process Changes

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non-value added deliverables * $BTF4UVEZ**&MJNJOBUFOPO

value added compliance approvals

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II.

Characterize Process

Monitoring Programs

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techniques

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III.

Interactive Exercise

Participants develop a monitoring program to eliminate a phase gate review.

Joseph Zec, Corporate Software Steward, Senior Manager, Corporate Software QA, Boston Scientiﬁc Corp

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I

3:15 Networking and Refreshment Break. 3:45 Cloud Computing Manage Risk in a

Conference Registration

Conference Chairperson’s Welcome and

Opening Remarks

Celebrating 30 Years of Computer Validation Trends,

Regulations and Directives

Computer System Validation Then and Now —

Learning Management in the Cloud

Networking and Refreshment Break

Cloud Computing — Manage Risk in a

Regulated Environment

Recent CSV Enforcement — Learn from Trends and

Proactively Avoid Part 11 Citations

Write Effective Software Requirement

Specifications

Close of Day One

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Continental Breakfast

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Review Traditional Disaster

Recovery (DR) and

Business Continuity (BC)

Activities

You and Your Team

Consider Hosted and

Cloud-Based Services

Interactive Session

What Is Risk Management?

Risk Assessment Tools

Risk Management Applied to Right

Sizing Your Computer Validation

Interactive Exercise #1

Interactive Exercise #2

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What are the Business

Advantages of Master Data

Management (MDM)?

Qualify or Validate MDM

systems and Data Services?

Validate Data Services against

MDM Standards

Interactive Exercise — Develop

a MDM Validation Strategy

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1

Cloud Computing Paradigms

Elements of a Cloud

Compliance Framework

Qualification and Validation of a

Cloud Computing Platform

Interactive Exercise #1

Interactive Exercise #2

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Develop Human-Based/

Static Testing Strategies

Develop Test Scenarios

Analyze Testing

Interactive Exercise

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_{and ASTM E 2500}

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