Canadian Good Manufacturing Practices: Pharmaceutical, Biotechnology, and Medical Device Regulations and Guidance Concise Reference - Softcover

Allport-Settle, Mindy J.

Softcover

ISBN 10: 0982147643 ISBN 13: 9780982147641

Publisher: PharmaLogika, 2010

Synopsis

Part I: Food and Drugs Act - Part A: Administration - Part C: Drugs Division 1 - Division 1A: Establishment Licences - Division 2: Good Manufacturing Practices Part II: Guidance Documents Part III: Annexes to the Current Edition of the Good Manufacturing Practices (GMP) Guidelines Part IV: Questions and Answers Part V: International Conference on Harmonisation (ICH) Guidance Documents - ICH Q1A(R2): Stability Testing of New Drug Substances and Products - ICH Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products - ICH Q1C: Stability Testing for New Dosage Forms - ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology - ICH Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - ICH Q9: Quality Risk Management, Part VI: Compliance Policies Part VII: Forms Part VIII: Extensive Index

About this title

About the Author

Mindy Allport-Settle has served as a key executive, board member, and consultant for some of the best companies in the pharmaceutical, medical device, and biotechnology industry. She has provided guidance in regulatory compliance, corporate structuring, restructuring and turnarounds, new drug submissions, research and development and product commercialization strategies, operational, project and contract management, and new business development. Her experience and dedication have resulted in international recognition as the developer of the only FDA-recognized and benchmarked quality systems training and development business methodology. Her education includes a Bachelor's degree from the University of North Carolina, an MBA in Global Management from the University of Phoenix, and completion of the corporate governance course series in audit committees, compensation committees, and board effectiveness at Harvard Business School.

Edition details

• Publisher: PharmaLogika
• Publication date: 2010
• Language: English
• ISBN 10: 0982147643
• ISBN 13: 9780982147641
• Binding: Paperback
• Number of pages: 828