Search Trainings
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
Sponsor's responsibilities for an Active Investigational New Drug (IND)
This webinar will shed light on all the sponsor’s responsibilities for an Active Investigational New Drug application (IND). Alongside this presentation would detail each of the sponsor’s activity in greater detail including timelines to implement the same. Wh ...
- Basic & Intermediate
- 60 Mins
- Gowri Sukumar
- Feb 11, 2020
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
- Feb 25, 2020
Statistical Methods for Quality Improvement
This webinar introduces important statistical concepts and methods for making objective decisions to ensure and improve product quality. The methods have many applications including: Determining how well my process/product meets requirements Knowing when a ...
- Intermediate
- 90 Mins
- Steven Wachs
- Mar 17, 2020
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
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