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

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

by Mindy J. Allport-Settle
     
 
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:

Overview

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

Product Details

ISBN-13:
2940011814662
Publisher:
PharmaLogika
Publication date:
04/26/2010
Sold by:
Barnes & Noble
Format:
NOOK Book
File size:
1 MB

Meet the Author

Following in the footsteps of Gordon Allport, all of Mindy J. Allport-Settle's books are built on a foundation of psychology and sociology with a focus on improving some aspect of industry through research and education.

Her career in healthcare began when she was a teenager working as an emergency medical technician. Since then, she has joined the U.S. Navy's advanced hospital corps, worked in organ and human tissue procurement, specialized in ophthalmology, and moved on to serve 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, 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.

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