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Validity : 17th Sep'26 to 27th Sep'26
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28 results of "Manufacturing x"
Live Webinar
The Validation Master Plan – The Unwritten Requirements
Verification and validation requirements have always been part of the US FDA’s cGMPs. However, with increasing technology, both industry, and regulatory agencies' expectations have increased. Recent high-profile field problems indicate that V&V activities are ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
- Sep 28, 2026
Recorded Webinar
The Validation Master Plan – The Unwritten Requirements
Verification and validation requirements have always been part of the US FDA’s cGMPs. However, with increasing technology, both industry, and regulatory agencies' expectations have increased. Recent high-profile field problems indicate that V&V activities are ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
Recorded Webinar
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
Recorded Webinar
Validation of GC/ GC-MS Methodologies
Instrumental gas chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation ...
- Intermediate
- 90 Mins
- John Fetzer
Recorded Webinar
The GCPs/GLPs/GMPs: Comparison and Understanding of the FDA’s 3 Major Regulations
This webinar will define what are the US FDA's expectations for proper laboratory / clinical / manufacturing practices, systems, equipment usage, and documentation / record-keeping. It will evaluate the requirements for how basic Quality Management System (QM ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
Recorded Webinar
How to Write SOPs for Human Error Reduction
Human error is the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo