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 4: Practical Approaches to Risk Assessment and Management Problem Solving: Tips and Case Studies
This publication is taken from the book: Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studie published in 2016.
Receive expert guidance on major topics, such as regulatory perspectives on risk and five insightful case studies to help develop the best approaches to problem solving based upon the "what if" and "five whys" method.
Available to download. Prior to purchase please view the download instructions and Terms of Usage
Format: PDF (1 file 2.50 MB)
Table of Contents:
Click here to download >>>Detailed Table of Contents
Introduction: Risk Assessment and the Production of Safe Healthcare Products
- Regulatory Perspectives on Risk (Chapter excerpted from Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies, Chapter 3)
- Problem Solving Question Based Approaches: The "Five
Whys" and "What if" Methods. (Chapter excerpted from Chapter 6)
- Case Studies: Aseptic Transfer Risk Assessment (Chapter excerpted from Chapter 23)
Risk Assessment for Intervention Scoring in Relation to Aseptic Processing (Chapter excerpted from Chapter 25)
Risk Consideration for Aging Pharmaceutical Considerations (Chapter excerpted from Chapter 28)
Risk Management and the Supply Chain (Chapter excerpted from Chapter 35)
Error Risk Reduction: Concept and Case Study (Chapter excerpted from Chapter 42)
Current Regulations, Guidances, Technical Reports and
Texts Useful for Further Reference.
About the Author
Tim Sandle has over twenty-five years of experience in pharmaceutical microbiology. Tim is the site microbiologist at the Bio Products Laboratory and he is a visiting tutor at the University of Manchester, where he teaches pharmaceutical microbiology. In addition, Tim is a longstanding committee member of the Pharmaceutical Microbiology Interest Group (Pharmig). Tim has worked on a number of different microbiological projects including developments in the testing of bacterial endotoxins and pyrogens; validation of culture media; establishing the environmental monitoring regime for a network of over two hundred clean rooms; qualifying several water systems; and validating a sterility testing isolator system. Tim has authored over three-hundred papers, articles and book chapters in relation to microbiology; and he has written or edited ten books.