Dublin, Sept. 21, 2026 (GLOBE NEWSWIRE) -- The "New EU GMP Annex 1: Compliant Sterile Medicinal Products (Apr 28th - Apr 30th, 2027)" Ttraining course has been added to ResearchAndMarkets.com's offering.
The training examines the updated EU GMP Annex 1 guidance, published in August 2022 and effective from August 25, 2023, including changes introduced following the first revision in 14 years. The programme addresses current expectations for sterile manufacturing environments, personnel, equipment and production technologies, with particular attention to contamination control, microbiology, sterility assurance and quality risk management.
Across three days, the course organised by IPI Academy covers aseptic processing regulations, facility design, environmental monitoring, bioburden control, sterilisation, cleaning and disinfection, critical utilities, cleanroom operation, HEPA filters, RABS and isolator technology, Contamination Control Strategy (CCS), Aseptic Process Simulation (APS), personnel qualification and aseptic gowning. Workshops are included throughout the programme.
The programme also addresses regulatory considerations involving authorities and organisations including the FDA, MHRA, TGA, WHO and PIC/S, alongside common deviations and practical recommendations.
Why You Should Attend
- Examine the requirements and practical implications of updated EU GMP Annex 1.
- Explore contamination control, environmental monitoring and sterility assurance.
- Review cleanroom design, RABS, isolators, BFS and FFS technologies.
- Address aseptic process simulation, personnel qualification and gowning techniques.
- Apply course topics through practical workshops and real-world examples.
Who Should Attend
The training is intended for personnel working across Quality Assurance and Quality Control, Validation, R&D, Audit, Regulatory, IT, Warehouse and Supply Chain, Engineering and Procurement, as well as Health Authority Inspectors.
Featured Speaker
Mustafa Edik brings more than 28 years of experience across GMP, GDP, GCP, GLP and broader GxP compliance. His experience includes more than 4,200 hours of GxP audits across over 200 facilities worldwide and training more than 9,000 professionals in GxP topics.
Professionals seeking focused training on EU GMP Annex 1 and sterile manufacturing can register their interest in attending at https://www.researchandmarkets.com/r/ptldjz
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