Cambridge Healthtech Training Seminars

Cambridge Healthtech Training Seminars

Monday, AUGUST 15 - Tuesday, AUGUST 16
Day 1 1:00-5:00 PM • Day 2 8:00 AM-5:15 PM

Identifying and Managing Risk during Development, Scale-Up, and Validation of Biological Processes

Seminar Description

The 2005 FDA policy paper entitled “GMPs in the 21st Century, a Risk-Based Approach” encouraged companies to look at the risks to their processes and systems, evaluate them and manage them. It was clearly stated by FDA that this initiative was not intended to replace compliance.

Most companies have now developed risk management programs. Risk assessment and risk management are now the industry norm, but are companies applying these tools in an intelligent and compliant way?

This seminar will look at the common, and some less common tools for risk assessment and risk management and will provide guidance on how these tools can be applied to the management of risk in pharmaceutical development, process scale-up and process validation of biological processes. The seminar will consist of presentations, break out workshops and discussions of examples of successful risk management programs.

Specific Subject Matter to be Covered

  • Historical and regulatory background to risk management
  • Identification of risks in process development, scale-up and process manufacturing
  • Tools for risk assessment in pharmaceutical development and manufacturing
  • Some other tools that are less frequently used
  • Introducing risk management into the Quality System
  • Examples of the application of risk assessment tools in development, scale-up and process validation
  • Mitigating and managing risk
  • New approaches to validation of bioprocesses
  • How should we document our risk assessments and risk management programs?
  • How can we measure success?
  • Examples of successful programs

Target Audience

This seminar is aimed at people working in all aspects of development and validation of biological processes, including those working in Development, Quality, Validation and manufacturing. It is primarily aimed at those whose exposure to risk management has been limited, but will also be of benefit to more experienced practitioners. It will also be of value to those involved in the fill/finish of biological drug product.

What Students will Gain from Attending

Students will gain:

  • An appreciation of the Regulatory goals of risk management
  • Practical knowledge of the many tools available to perform risk assessment
  • Knowledge of how to make informed decisions regarding risk management strategies based on scientific principles
  • Practical advice on how to document their risk programs
  • An understanding of what procedures and tools are needed and what are not
  • An understanding of how to measure the success of risk management programs
  • Information on some examples of some successful programs

About the Instructor:

Trevor DeeksTrevor Deeks, Ph.D., QA and QC Consultant, Teva Biopharmaceuticals USA, Inc.

Trevor Deeks has spent more than 36 years in pharmaceutical manufacturing and has diverse experience including process and analytical development, Quality Control, Quality Assurance, process validation, and facility start-up and qualification. He has held senior management roles in QA, QC and Process Development. During this time he has been involved in the development of risk programs and procedures, many of which have been presented to FDA assessors and inspectors, with a high level of success.

He was formerly a Registered Qualified Person (QP) for many years in the UK. He also led a number of new facility startups, technology transfers and validation projects, with involvement in the development and commercialization of a number of currently marketed products. He has worked for several years as a GMP and validation consultant in Europe.

He is an experienced speaker and writer, who has published over 30 papers, several books and many book chapters. He is an active presenter and workshop leader at PDA, ISPE, and independent conferences. He launched the European Journal of Parenteral Sciences for the UK Parenteral Society in 1996, and remained as Editor-in-Chief until 2000.

He now runs his own consulting business and works as a QA and compliance consultant. He spends much of his time consulting on Quality Systems, Phase-Appropriate GMP, working with CMOs, performing QP-type audits and advising small US-based companies on how to meet the requirements of the European Clinical Trials Directive and how to get their Investigational products into European clinical trials.


Premier Sponsors:


Millipore Sigma

Unchained Labs