Search Trainings
Review of Chemistry, Manufacturing and Controls (CMC) of an Investigational New Drug Application (IND)
Outline of the relevance of information from the CMC perspective Understanding differences between small molecules and Biologics Glimpse of CFR 312.22 with the highlight on the FDA’s primary objectives in reviewing an IND Overview of Pre-IND activities C ...
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Nov 19, 2019
FSMA Preventative Controls for Sanitary Transport For Logistics Professionals
Aside from regulatory requirements, liability for the safety of an organization’s food products will be covered. The importance of documentation control is critical in this area.
- Basic & Intermediate
- 60 Mins
- Gina Reo
- Nov 21, 2019
HACCP - How To Create A HACCP-Concept And How To Deal With CP's And CCP’s?
The HACCP methodology as risk management methodology is mandatory for pharma and food manufacturing and quality assurance. A quality assurance department needs to create and maintain HACCP files documentation and find and define the checkpoints (CP) and critic ...
- Intermediate
- 90 Mins
- Dr. Dr. h.c. Fr
- Nov 21, 2019
FDA Best Audit Behavior Practices – Do’s and Don’ts
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, a ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
- Nov 22, 2019
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries.Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented.Human errors start at the design stage.Fro ...
- Basic & Advanced
- 90 Mins
- Ginette Collazo
- Nov 26, 2019
Understanding Initial IND Submission- The first 30 days
This webinar will shed light on the entire process that takes place from the time the sponsor submits the initial IND to the FDA for initial 30-days. Alongside this presentation would detail the various grounds on which the FDA may consider placing a clinical ...
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Nov 26, 2019
Technical Writing in the Pharmaceutical Industry
Technical writing in the Pharmaceutical Industry is a highly specialized field. Technical writing differs from general correspondence in that it is written for a specific audience. Technical writing is a balancing act between being precise enough to cover the ...
- Basic
- 60 Mins
- Robert Peoples
- Dec 10, 2019
FDA Regulations for Pharmaceutical Current Good Manufacturing Practices
This webinar will review all the sections of FDA cGMP regulations. Regulation text and examples from the instructor’s experience will be presented. Warning Letters and Inspectional Observations will be used as examples of what not to do.
- Basic
- 90 Mins
- Loren Gelber
- Dec 12, 2019
GMPs for Medicinal Cannabis Growers and Processors
The medical marijuana industry is in its infancy in the United States. A large number of individual states have legalized medical marijuana to varying levels of control and regulation. Medical marijuana is illegal on a US Federal level but all predictions are ...
- Basic & Intermediate
- 60 Mins
- Charles H. Paul
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the r ...
- Intermediate
- 90 Mins
- Joy L. McElroy