Programme Structure

PR5303 Good Regulatory Practices

This course provides an introduction to cGMP (current good manufacturing practices). Regulations for drugs under the Food, Drug and Cosmetic Act (21 CFR 210 and 211) and their implication for personnel, buildings, equipment, and records will be thoroughly reviewed and studied. It includes a study of pertinent legal decisions and regulatory actions based on non-compliance.

Module Outline

1. Internet Resources
1. FDA home page  & GMPs for the 21st Century
2. ICH
3. Canada
4. Other countries – to be identified
5. Other Misc. resources
1. trade publications – Pharm Tech
2. GMPs – (US first)
1. Preamble
2. 21 CFR Parts 210 & 211 (Definitions & Regulations)
3. Videos
1. No Margin for Error
2. No Problems
3. The Letter
4. The Inspector
5. Unsolved Pharmaceutical Mysteries
6. Snapshots
7. Validation
8. Exit from the GMP Zone
4. Global GMPs
5. ICH – Quality guidelines
6. Inspections – Compliance Policy Guideline
7. Consequences of Non-compliance
1. US
2. Canada
3. EU
4. ROW
5. China
6. Japan
7. Others
8. Case Studies
1. Barr Laboratories
2. Able Labs
3. Glycerin – global ramifications
4. Heparin – global ramifications
9. Assignments
1. Weekly threaded discussions
2. Weekly reading assignments
10. Articles for Threaded Discussions

Timetable

Biodata of Lecturer
Karen R. Zimm, RPh, BS, MS, MBA, PhD, a Regulatory Affairs Manager for Johnson & Johnson Pharmaceutical Research and Development (Titusville, NJ) is responsible for providing strategic input to the planning and preparation of global regulatory submissions related to Chemistry Manufacturing & Controls (CMCs) for drug substance and marketed products as well as subsequent interaction with global health authorities.  Previously, she held positions at Johnson & Johnson, overseeing technical operations (transferring products from development to full scale operations) with Pharmaceutical Sourcing Group–Americas (a division of Ortho-McNeil Pharmaceutical), and handling formulation development of oral solid and liquid dosage forms for the R.W. Johnson Pharmaceutical Research Institute. She also held the position of formulation scientist for Whitehall Robins Healthcare (Wyeth Consumer Products).  Dr. Zimm earned her BS in Pharmacy and PhD in Pharmaceutics from the Philadelphia College of Pharmacy and Science; she holds an MBA in Pharmaceutical Management from Drexel University, and an MS in Quality Assurance/Regulatory Affairs from Temple University.  In addition she is a licensed pharmacist in NJ, DE, MD and VA.  She has taught and developed several courses for the QA/RA graduate program, including Advanced GMPs and PAC (Post Approval Changes).  She has led the development of remote course delivery for the QA/RA program and is known for her enthusiastic teaching style. An active member of the American Association of Pharmaceutical Scientists (AAPS), she currently serves as Vice-Chair of the AAPS Regulatory Sciences Section.

Module 5303 is one of ten required modules that will lead to a Masters in Pharmaceutical Sciences and Technology, conferred by National University of Singapore. For complete list of modules and entry criteria for Msc (PST) please refer to http://www.pharmacy.nus.edu.sg/prospective/prog_gadmcintro.html