Risk Management Library Volume 2: Practical Approaches to Risk-Based Compliance (single user digital version)

Feb 2018
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series

The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is the time to get up to date on managing risk to safely produce healthcare products!

In order to help you, we have gathered chapters from our most successful risk-based texts. These convenient, electronic texts define risk, discuss hazards and risks, provide tools to help you evaluate risk, and develop effective strategies for dealing with risk.

Written by subject matter experts, each text contains practical applications, an extensive list of international regulations for reference, and suggested PDA Technical Reports and books for further guidance.

Risk Management Library Volume 2: Practical Approaches to Risk-Based Compliance

This publication is taken from the book: Risk-Based Compliance Handbook published in 2008.

This Volume offers guidance in implementing process analytical technology (PAT), discusses the challenges and pitfalls of applying a science and risk-based approach in research and manufacturing, and presents documented evidence for risk-based compliance.

Available to download. Prior to purchase please view the download instructions and Terms of Usage
Format: PDF (1 file 4.60 MB)

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

Introduction: Industry Trends in Risk Management

  1. Risk-Based Approach to Compliance (Chapter excerpted from Risk-Based Compliance Handbook, Chapter 4)
  2. Implementing Process Analytical Technology: The Challenges and Pitfalls of Applying a Science and Risk-Based Approach in Research and Manufacturing by Siegfried Schmitt and Jennifer Thompson. (Chapter excerpted from Risk-Based Compliance Handbook, Chapter 5)
  3. Benefit Risk Assessment During Research and Development by Siegfried Schmitt, Yvonne Lis and Michael Carter. (Chapter excerpted from Risk-Based Compliance Handbook, Chapter 7)
  4. Documented Evidence (Chapter excerpted from Risk-Based Compliance Handbook, Chapter 12)
    Current Regulations, Guidances, Technical Reports and Texts Useful for Further Reference.

About the Authors

About the Authorss

Siegfried Schmitt, PhD is a Member of the Royal Society of Chemistry, Chartered Chemist and Chartered Scientist. Having worked in industry and in the consulting business he has more than 18 years experience in the healthcare industry. In 2007 he joined PAREXEL Consulting in the UK as Principal Consultant in the Strategic Compliance and Operational Performance Excellence team. He regularly publishes articles on scientific and business subjects, and has written several books. He speaks at international conferences and industry meetings on a variety of topics, especially covering the integration of modern business methodologies with compliance. He is the author of The Manager's Validation Handbook: Strategic Tools for Applying Six Sigma to Validation Compliance and Understanding Active Pharmaceutical Ingredients.

Yvonne Lis, PhD is an experienced health outcomes researcher with more than 25 years in the industry. Her clinical research in London teaching hospitals was marked by several publications in peer reviewed journals and her subsequent commercial experience has focused on epidemiology, pharmacoepidemiology, pharmaco-economics and risk management. Most recently she has been working with the international pharmaceutical industry on the application of outcomes research methodologies to address the emerging market access challenges faced by products in Phase II/Phase III development. She regularly contributes to International Society Pharmacoeconomics and Outcomes Research (ISPOR) working parties including: Good Research Practices for Registries; Using "Real World" Data in Coverage and Reimbursement; Good Research Practices for Drug Cost, Economic Evaluation Research and Use in Health Care Policy. A Fellow of the Royal Society of Medicine, she has also been a Senior Research Fellow at the Department of Medicine and Epidemiology, McGill University, Canada.

Michael Carter is an experienced health outcomes researcher having provided consultancy support to the international pharmaceutical industry for more than 15 years. His considerable previous experience in product development and business strategy enable him to provide a clear focus on ensuring that the science being performed is clearly aligned with the achievement of key business objectives. He is a regular speaker at industry conferences and has recently served as a non-executive director of a UK Primary Care Trust.

Jan Olsen CEO Clarmon Corporation, is an experienced senior manager in IT, mechanical engineering and compliance management. He has over 17 years of IT and compliance management experience from a long list of listed companies. He has very strong experience in both compliance tool development and IT implementation, having worked as MD, CTO and Executive Director on several successful technology start-ups. He also served as general manager of a largescale offshore facility in Romania with a 350+ engineering staff delivering engineering solutions to a number of regulated companies. Jan holds a B.Sc. in Business and an M.Sc. in Management.

Jennifer Thompson (previously Methfessel) is an IT and computer systems compliance expert with more than 15 years of experience across a wide range healthcare companies, system suppliers and service providers in the UK, Europe and USA. She joined ABB eight years ago where she is a Principal Consultant in Validation and Compliance Consultancy and works closely with the ABB Process Analytical Technology Centre of Excellence. She has a special interest in PAT as she has a Ph.D. in physics, specialising in spectroscopic techniques. She is a Member of the Institute of Physics, chartered physicist and has a Diploma in Business Management. An active member of ISPE and GAMP, she regularly writes articles and presents at international conferences. Jennifer particularly enjoys applying her business knowledge and scientific training in working with clients to develop and implement risk-based strategies for PAT, business systems and IT and computerised systems compliance, validation and qualification.