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GMP/GDP UpdatesGMP Refresher and Updates:
Review of US GMPs 21CFR part 210, 211, 600 and part 11
Review of EU GMPs Eudralex volume 4 part 1, 2, 3 and related GMP documents
GMP guidances, Pharmacopeias, PIC/s, WHO, ICH and more…
This Refresher will meet your requirement for annual GMP training! ON THE MENU-25264
- Hot topics:
- Recent inspection findings
- Review and discuss US FDA 483 and warning letter findings
- Updates to:
- EU GMPs and annexes, guidelines
- US GMPs and guidances
- ICH
- PIC/s
- WHO
- Pharmacopeias
- Want to know what’s happening in the pharmaceutical industry? Come...Continue reading
Have a question? We have the answer
Issues to be covered
Included in the GMP updates:
- Identification tests of starting material and reduced monograph testing
allowed? Or not? - Process monitoring and batch release – statistical process control?
- ICHQ3C Residual solvents update – just issued
- PIC/s updates: vision of one inspection which satisfies all global regulators (FDA, EU, Japan etc.)
- Implementation of Annex 1: Sterile Product manufacture and the Contamination Control Strategy
- Inspection efforts – EU GMP/GDP Inspectors workplan for 2024 – 2026:
– Enhance supply chain traceability, oversight and security
– Guidance reinforcing responsibility for product quality:EU level data integrity guidance
together with WHO and PIC/s
– Revisions to Chapter 4 of the GMPs: Documentation
– Revised Annex 11: Computerised Systems
– Revise ATMP GMPs
– Revised Annex 15: Qualification and Validation addressing new technologies (AI and ML)
– ICH Q12 Lifecycle management integration into inspections
– PIC/s – ICH MOU and increased cooperation / enforcement of ICH guidance?
The course will address all of the checkboxes above and more and will pull together the threads to allow you to understand where to focus limited resources for maximum return on investment
Objective:
Provide a rapid update of GMP regulations, their ongoing development and interpretation. This course will allow participants to gain a new perspective on old topics and figure out what the inspector is focusing on and where the next surprise might be.
Who should attend
Who should attend
Those working in the pharmaceutical industry including:
- Company General Managers
- Managing Directors (effective quality systems focus on executive management actively leading the system)
- Hospital pharmacists & QPs
- Quality Assurance, Quality Control and other quality professionals
- Operations Managers
- Production Managers
- Research and Development (R&D)
- persons working in technology transfer, pharmaceutical Active Substance and finished product manufacture as well as distributors, brokers, wholesale dealers
- Anyone involved in the handling, processing or sales or administration of any of these
- Persons involved in clinical trials and manufacture and administration of Investigational Medicinal Products will also find the course useful
Benefits to the Participants
Participants will come away with a list of sources for GMP updates and a rapid overview of the changes that have recently been implemented and those under consideration / comment.
About The Lecturer
Karen Taylor (Ginsbury)
Karen Ginsbury, CEO of PCI Pharmaceutical Consulting Israel Ltd. Karen
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