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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
Acceptance Sampling for Process Validation and Production Lot Monitoring
Personnel involved in process validation and production control often rely on sampling methods to determine the suitability of a process before moving to production (process validation) or for checking production lots for acceptance. This webinar provides deta ...
- Intermediate
- 90 Mins
- Steven Wachs
- Jan 24, 2020
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
- Feb 03, 2020
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
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
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
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
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
FDA's Regulation of Over-the-Counter (OTC) Drugs Monographs and NDAs for Safety and Efficacy Goals
The three ways that the FDA regulates OTC (Over-the-Counter) drugs: Monographs, Rx to OTC switches and NDA/ANDA submissions, will be discussed in detail. Labeling and advertising of OTC drugs will be covered. Other requirements, including Registration, Drug Li ...
- Basic
- 75 Mins
- Loren Gelber
The Use Of Statistical Process Control (SPC) Using Control Charts To Maintain Compliance In The Laboratory
Statistics can be used to monitor critical variable in the running of a procedure and in the performance of the instrumentation that performs it. By applying Nelson’s rules this data can be evaluated as performing as expected or performing in ways that are sta ...
- Basic & Intermediate
- 60 Mins
- John Fetzer