Dublin, July 06, 2026 (GLOBE NEWSWIRE) -- The "New EU GMP Annex 1: Compliant Sterile Medicinal Products (Nov 24th - Nov 26th, 2026)" has been added to ResearchAndMarkets.com's offering.
Research and Markets is offering "New EU GMP Annex 1: Compliant Sterile Medicinal Products," a three-day online training course developed with IPI Academy, running November 24–26, 2026 and delivering 18 CPD hours of practical guidance on the most significant overhaul of EU sterile manufacturing regulation in over a decade, led by 28-year GxP compliance veteran Mustafa Edik.
The updated EU GMP Annex 1 was published in August 2022 and came into force on 25 August 2023, the first revision to the guidance in 14 years. For quality, regulatory, and manufacturing teams across the pharmaceutical, biotechnology, and medical device sectors, that regulatory reset has created an ongoing compliance burden: aseptic facilities, contamination control strategies, and sterility assurance programs built around the 2008 framework must now be reassessed against expanded, globally harmonized expectations. This new three-day online training course, available through Research and Markets, is designed to close that gap with a structured, expert-led breakdown of what changed and what it means for day-to-day aseptic operations.
Comprehensive Coverage of Sterile Manufacturing Compliance
The course provides a full overview of the Annex 1 changes and their practical implications for aseptic processing, personnel, equipment, and production technology. Structured across three days, the program moves from foundational regulatory and facility design principles into hands-on technical detail: Day One covers aseptic processing guidelines, facility design, quality risk management, microbiology fundamentals, environmental monitoring, and bioburden control, reinforced by an applied workshop. Day Two addresses cleaning, disinfection, sanitation and decontamination practices, sterilization, visual inspection, critical utilities, cleanroom and airlock design, Blow-Fill-Seal (BFS) and Form-Fill-Seal (FFS) technologies, HEPA filtration, and RABS and isolator technology. Day Three focuses on Contamination Control Strategy (CCS), microbial contamination investigation, residue and fiber prevention, Aseptic Process Simulation (APS), personnel gowning and behavior, airflow visualization, and sterile product filling, stoppering, and sealing, closing with a dedicated session on regulatory considerations for aseptic processing.
Throughout, the training maps course content against regulatory expectations from the FDA, MHRA, TGA, WHO, and PIC/S, giving participants a cross-jurisdictional view of common deviations and practical remediation strategies rather than a single-market perspective.
Why This Course Matters
- Direct regulatory relevance: Built entirely around the August 2023 EU GMP Annex 1 revision, giving teams an up-to-date reference point rather than guidance based on the outdated 2008 version.
- Multi-agency regulatory mapping: Session content is cross-referenced against FDA, MHRA, TGA, WHO, and PIC/S expectations, supporting compliance strategies for companies operating across multiple regulatory regions.
- Applied, workshop-based learning: Three dedicated workshops translate risk management, cleaning/disinfection, and CCS concepts into real-world application rather than theory alone.
- Full-spectrum technical scope: Coverage spans cleanroom design, RABS and isolator technology, BFS/FFS, HEPA filtration, and Aseptic Process Simulation, the core technology stack underpinning modern sterile manufacturing.
- CPD-accredited credentialing: The course carries 18 CPD hours, supporting formal professional development records for quality and regulatory staff.
Practical Value for Compliance and Manufacturing Strategy
For organizations managing sterile manufacturing operations, this training translates directly into operational readiness: teams can benchmark existing Contamination Control Strategies, cleanroom classifications, and personnel qualification programs against current regulator expectations before an inspection identifies the gap. The multi-agency regulatory framing, spanning FDA, MHRA, TGA, WHO, and PIC/S is particularly relevant for companies supplying multiple markets, where divergent interpretations of Annex 1 principles can create costly rework or delayed approvals. Sessions on RABS, isolators, BFS, and FFS give engineering and validation teams a structured reference point when evaluating or upgrading production technology, while the dedicated CCS and APS content supports audit and inspection preparation.
Research and Markets notes that organisations including Pall Corporation, Syngene International, Thermo Fisher Scientific, Novasep, Alcimed, and Benchmark Products are among its clients, reflecting the level of industry engagement with its training and research portfolio.
The training is led by Mustafa Edik, Founder and Lead Consultant at Quality Academia Eğitim & Danışmanlık, who brings over 28 years of hands-on leadership in GMP, GDP, GCP, GLP, and broader GxP compliance across pharmaceutical, biotechnology, and medical device industries. He is Turkey's first IRCA-certified Lead Auditor for GMP and Pharmaceutical Quality Management Systems, has personally led more than 4,200 hours of GxP audits across over 200 facilities worldwide, and has trained over 9,000 professionals in GxP topics.
Full course details, agenda, and enrollment are available at: https://www.researchandmarkets.com/r/q3wbrd
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