×

Uh-oh, it looks like your Internet Explorer is out of date.

For a better shopping experience, please upgrade now.

Canadian Good Manufacturing Practices
     

Canadian Good Manufacturing Practices

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

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:
9780982147641
Publisher:
PharmaLogika
Publication date:
04/26/2010
Pages:
828
Product dimensions:
7.00(w) x 10.00(h) x 1.64(d)
Age Range:
18 Years

Meet 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.

Customer Reviews

Average Review:

Post to your social network

     

Most Helpful Customer Reviews

See all customer reviews