Saturday, 22 February 2014

Achieving Quality and Compliance Excellence in Pharmaceuticals

'Achieving Quality and  Compliance Excellence in Pharmaceuticals' is a book covering a range of topics relating to GMP, edited by Madhu Raju Saghee.

Here are the topic covered and a list of the expert authors:

1 Fundamentals of Global GMP Requirements by Atul Shirgaonkar

2 Effective CAPA Management for Optimal Compliance by Michael Hopper

3 Laboratory Compliance and Handling Out-of-Specification (OOS) Results in the  Laboratory  by John Lanese and A.V. Prabhu

4 Effectively Incorporating Quality Risk Management into Quality Systems by Tim Sandle and Sanjit Singh Lamba

5 Monitoring and Controlling Process Drift for Enhancing Quality by Nandkumar Chodankar

6 Qualification and Validation by Tim Sandle

7 Process Validation by Mark F. Witcher

8 Documents, Records, and Part 11 Compliance by Janet Gough

9 Change Control and Management by R. Raghunandanan

10 Deviation Management by Alicia Tébar Pérez

11 Internal Quality Assessments/Self-Audits by R. Raghunandanan

12 Designing an Effective GMP Training Program by David Markovitz

13 Behavioural GMPS (bGxP®): A New Paradigm in Compliance Management by Brian Szukala

14 Supplier Quality Management by Ajit Basrur and David Stephon

15 Understanding the United States Pharmacopeia (USP) by Robert D. Seltzer

16 Spotting Overall Weak GMP Compliance Systems by Robert D. Seltzer

17 Meaningful Performance Metrics for Compliance by Roger Janczak

18 Implementing ICH Q 10: A Pragmatic Approach by Alok Ghosh and Nilanjana Basu

19 Compliance Aspects of APIs Manufacturing by Richard Einig

20 Compliance Aspects of Sterile Manufacturing by Tim Sandle and Madhu Raju Saghee

21 Domestic and International U.S. Food and Drug Administration (FDA) Inspections by Robert D. Seltzer

22 Avoiding FDA Enforcement Actions: An Optimal and Sustainable Compliance
Program by Areta Kupchyk

23 Developing a Master QMS Plan by John E. Lincoln

24 Trends in cGMP Compliance by Mitch Manning

For a free chapter extract and further details about the book go to: GMP

To purchase a copy of the book, see Achieving Quality and Compliance Excellence in Pharmaceuticals

Posted by Tim Sandle