הנושאים שמעניינים אותי
(אפשר לבחור מספר נושאים)
עדכוני GMPIncluding recent updates
This Refresher will meet your requirement for annual GMP training!
ON THE MENU:
- What’s hot:
- 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...המשך קריאה
יש לך שאלה? יש לנו את כל התשובות
מה תכני הקורס?
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.
למי זה מתאים?
This course is suitable for:
Anyone 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
מה אקבל מכך בפועל?
Participants will come away with a list of sources for GMP updates and a rapid overview of the changes that have been recently implemented and those under consideration / comment.
מי מעביר את הקורס?
