The pharmaceutical and allied industries are required to operate under the strict regulations of the current Good Manufacturing Practices. cGMP regulations are spelled out in the Title 21 of the Code of Federal Register (CFR) under the Parts 210 & 211, last revised as of April 1, 1994. The regulation mandates the cGMP training under the part § 211.25:

Personnel Responsibility: "Training shall be in the particular operations that the employee performs and in the current good manufacturing practice (including the current good manufacturing practice regulation in this chapter and written procedures required by these regulation) as they relate to the employee’s functions. Training shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them".

These regulations are pre-fixed ‘current’, because as the technology evolves, it allows the regulation to be updated to the today’s technology and sophisticated thinking. These regulations are periodically updated and the FDA expects the industry to keep pace with the current FDA thinking and the interpretation there of. The latest revision was published in the Federal Register on May 3, 1996.

Companies with visionary management know the importance of cGMP training. The periodic training can be a productive tool and helps compliance.

The cGMP Training Institute was formed to help the management in conducting periodic training to the employees. The cGMP training Institute takes away all the hassle of scheduling and conducting the employee training. We also provide documentation of attendees along with the subject matter discussed and take-home handout materials. Every session is geared towards employee understanding the principles of the GMP, practical approaches to achieve compliance and documentation. The general cGMP course consists of 15 sessions covering entire GMP regulations (CFR Title 21, parts 210 & 211). In addition, we also provide at a reasonable cost, ancillary technical training in the following topics :

1. Effective strategies to escort the FDA investigator.
2. How to Ensure a Successful Pre Approval Inspection (PAI).
3. Interdisciplinary Validation Teams Formation.
4. Effective development of Process Validation Protocols & Reports.
5. How to write the Product Development Reports(PDR).
6. How to write the QA Investigation Reports.
7. Statistical Process Control (SPC).
8. Organization of the Self Inspection Program.
9. Writing Skills improvement for Chemists and R&D Scientists.
10. Effective implementation of a Vendor Certification Program.
11. Practical guide for setting up a Stability System supportive of the expiry dates.
12. Analytical Methods Development & Methods Validation.
13. ISO 9000 Overview for Pharmaceutical & Medical Device Industry.
14. Ways to Comply the GLP requirements.
15. Elements of the SUPAC ( IR, MR, SS) and the ICH guidelines.
16. Compounder’s training for manufacturing personnel.
17. Basics & Application of HPLC principles for the laboratory personnel.
18. Microbiology & Environmental Monitoring in the pharmaceutical industry.

We are working on several other training courses. We also develop customized courses based on the individual company needs. Feel free to discuss with us regarding your specific needs.