USA PROJECT REFERENCES
Support the analytical method validation for remediation efforts
REMEDIATION-QUALITY CONTROL
Context and Objectives:
• Team of (5) Senior and Junior QC Consultants performing method validation for remediation efforts
• Optimizing knowledge Management
• Measurement of the quality of service through KPIs • Bench of QC Analytical Scientists (on Hand)
Approach & Solution:
• Methods/SOPs triaged with respect to priorities and target timelines for completion
• Background information on relevant observations made by regulatory agencies and responses
• Expectations: Confirm which elements of validation are in scope, e.g., robustness testing
Results & Added Value:
• Validation SOPs and associated CAPA’s if any
• Method specific observations during both internal and external inspections and responses. • Investigations, change controls and deviations involving each method and CAPA’s
• Validation protocols • Validation reports • Method Transfer Reports • Method Development Reports
• Reports on Purposeful Degradation Studies conducted and who to contact for samples if needed for validation.
• Samples of all excipients, starting materials, process related impurities, intermediates, degradants, excipients, etc. and contacts • Specifications where methods are cited
• Contact for questions with respect to analytical method • Access to statistician if needed for method robustness DOE’s
OMS Oncology (USA/R&D/IS)
Context & Objectives
Approach & Solution
Results & Added Value
Development to meet the rapid needs of the company’s biomedical research division.
Functional Environment: Technical Environment:
Life Sciences
OMS Oncology development provides many of cross divisional agile web software development and reporting needs.
Priding itself on a small, agile but highly adept technical team is one of the company’s most sought after internal rapid development staff that can get a system designed, developed and deployed into production without any red tape, utilizing a Common Data Model approach and lightning fast software development architecture, tools, and technologies.
The team has implemented and continues to develop a number of very visible and successful software projects for client site.
These accomplishments include creating a Common Data Model for establishing future projects and developing projects such as BMD, OMS, ENC-OMS, VMS, and TTG to name a few.
Other projects are underway including CRIKET and integrating financials.
The OMS Oncology team is setup to be an internal rapid development resource response team at client site and to be a very agile and very effective group that works outside normal IT and thus doesn’t have many of the same restrictions and encumbrances you would find in normal IT departments.
The team currently consists of 9 resources (3 DBAs, 1 architect, 4 UI developers, 1 PM/QA). Each resource is capable of working in different roles and conducting different responsibilities from time to time. Also each member has to be flexible and resourceful and be able to work in different environments and work for the most part
independently and effectively with some communication and very little specifications.
Thus, new members must be adept, seasoned, flexible, and work outside the box to be successful.
R&D, Oncology
JavaScipt, ExtJS, AJAX, PL SQL, HTML, XML, JSON, CSS, Java Altran
Process Engineering
Support development, execution of pilot runs, and tech transfer of processes.
Context and Objectives:
•
Support operationally 50 and 500P bioreactor, sweco,
mixer, and centrifuge
•
Execution of development and pilot runs for
proprietary cell harvest process
•
Provide data analysis and statistical analysis of pilot
runs
Approach & Solution:
•
Generating development study
summaries
•
Drafting SOPs and batch records
•
Performing statistical analysis using
industry standard techniques
Results & Added Value:
•
Daily support of operations in south side lab
•
Proper documentation generated to support tech
RISK MANAGEMENT
Assisting with systems engineering activities for products, including risk management
and product requirements improvements, leading to safer products.
Context and Objectives:
•
Conduct product risk assessments for purposes of
product remediation
•
Implement new product requirements for purposes of
product remediation
•
Support efforts to react to product issues
Approach & Solution:
•
Leading risk assessment of current
products
•
Leading creation of component-level
requirements for current products
•
Supporting various regulatory
inquires/responses and investigations
Results & Added Value:
•
Enables Hospira to update product files for FDA
compliance
•
Ensures timely responses to regulatory inquiries of
products
•
Allows easy future maintenance of new risk
ENGINEERING AND TECHNCAL WRITING SUPPORT
Provide process engineering consultant services and general management
support (VALIDATION)
•
Review, revise, and generate
Validation protocols and SOPs
related to Consent Decree Validation
and remediation.
RAPID (US, Sweden, UK/R&D/IS)
Context & Objectives
Approach & Solution
Results & Added Value
Scalable and flexible software development service providing rapid response to business demand
for IS support.
Functional Environment: Methodologies:
Technical Environment:
Life Sciences
The Rapid service provides quick response to local needs for minor to medium-sized applications / tools. Each activity should require no more than 3 man-months of total effort to complete and focus on a prioritized business need that can be solved in that timeframe.
The service should be sized to respond to all prioritized needs within 4 weeks (time from request to start of work).
A key feature of the service is that the solution is developed in close collaboration and direct (on-site) interaction between the developer and the users, in a fast and responsive way.
Altran staffed the service to 100% from 1stof May 2012. The staffing
level starting from 2 FTE’s in the early stages and reaching 21 FTE’s by mid June 2012 across four R&D sites.
The service has turned out to be even more effective than the client initially expected, maintaining a premium standard when it comes to skill-set and experience and interacting directly on local basis with the end-users with a much appreciated result.
As the footprint of the service has been established, new clients other than the original has shown interest in starting using this flexible, scalable and rapid way of getting maximum value provided by IS solutions.
The service is setup with local teams at each site, each consisting of three to eight resources. Each resource is able to take on the role as business analyst, developer and project manager.
The teams are constituted of a mixture of consultants with a technical and scientific background, with everyone capable of producing efficient and qualitative software.
The Altran Global Service Coordinator ensures that cross-site collaboration takes place where beneficial, that good solutions are reused and that ways of working are made both efficient and consolidated across the four sites.
Regulatory Affairs, Preclinical,Clinical, PAR&D, Operations, GxP, 21 CFR Part 11, ECM Rational Unified Process
Documentum 3, 4, and 5, Oracle, FileNet, Visual Basic 6, Java, XML Altran
Quality Assurance Support
•
Preforming critical
assessment and suggest
changes to deviation system,
change control system and
document control system
•
Review process development
reports
•
Quality oversight for
technology transfer
Senior Consultant Supporting Deviation Management for Biotechnology
Company
Upstream Technical Support
Identify solution to process filtration issues
Context and Objectives:
•
After transfer, process experienced complete filter
plugging during the harvest phase at full scale.
•
Need to identify filter alternatives that will allow
entire volume to be processed in the current
equipment without product loss or exposing product
to the environment to replace filters.
Approach & Solution:
•
Design pilot scale experiments to
evaluate different depth filter media as
well as downstream membrane media.
•
Primary and secondary configurations
identified that should provide the
required capacity.
Results & Added Value:
•
Full scale runs to be performed in Q1 2013 to confirm
study results.
•
Prevent product loss, reduce processing time, and
