GMP Advanced Masterclass For Pharmaceutical And Biotechnology Industries Scheduled For December 9-11, 2026, Focusing On Modern Quality Systems, Data Integrity And ATMP Compliance
Dublin, Oct. 02, 2026 (GLOBE NEWSWIRE) -- "GMP Advanced Masterclass for Pharmaceutical and Biotechnology Industries (Dec 9th - Dec 11th, 2026)" has been added to ResearchAndMarkets.com's offering.
Key Event Facts
- Course: GMP Advanced Masterclass for Pharmaceutical and Biotechnology Industries Date: December 9-11, 2026 Time: December 9th 08:30 to December 11th 17:00, GMT Format: Online Duration: 3 Days Focus: Advanced GMP quality systems, including ATMPs, automated systems, data integrity, and proactive risk management
In the pharmaceutical and biotechnology sectors, a robust, compliant, and forward-looking GMP framework is both a regulatory necessity and a core business driver. This masterclass bridges the gap between traditional GMP principles and newer areas of practice:
- Advanced Therapy Medicinal Products (ATMPs) automated systems data integrity proactive risk management
Participants explore the reasoning behind global regulatory expectations from the FDA, EMA, WHO, and PIC/S. They learn how to design and execute quality strategies that withstand rigorous inspections, optimise operational efficiency, and protect patient safety. The course carries 18 CPD hours.
Course Content
Day 1:
- the evolving global GMP landscape next-generation quality risk management (QRM) advanced deviation management and root cause analysis (RCA) a workshop on risk-based deviation case studies
Day 2:
- modern data integrity governance the shift from computer systems validation (CSV) to computer software assurance (CSA) sterile manufacturing and Annex 1 dynamics biotechnology and ATMP-specific GMP challenges
Day 3:
- product lifecycle and tech transfer (ICH Q12) supply chain GMP and vendor qualification inspection readiness and handling hostile audit scenarios a panel discussion on the future of pharma (Pharma 4.0) wrap-up and evaluation test
Why You Should Attend
- Apply next-generation quality risk management and advanced root cause analysis through risk-based deviation case studies. Strengthen data integrity governance and understand the move from CSV to CSA. Address sterile manufacturing under Annex 1 and the specific GMP challenges of biotechnology products and ATMPs. Prepare for inspections, including handling hostile audit scenarios, and manage tech transfer under ICH Q12. Earn 18 CPD hours upon completion of the course.
Business Relevance
The course content applies directly to the responsibilities of experienced professionals who design, operate, and defend pharmaceutical and biotechnology quality systems. It supports an understanding of FDA, EMA, WHO, and PIC/S expectations, along with the inspection readiness, supply chain, and lifecycle requirements that shape GMP compliance.
Who Should Attend
The masterclass is designed for professionals with a minimum of 3-5 years of experience in the pharmaceutical, biomanufacturing, or medical device industries, including:
- Quality Assurance (QA) directors, managers, and specialists Quality Control (QC) managers and lead analysts regulatory affairs professionals production and manufacturing managers and engineers validation engineers and specialists Qualified Persons (QPs) and Responsible Persons (RPs) GxP auditors and regulatory inspectors
The course runs December 9-11, 2026. Experienced GMP professionals should plan their participation ahead of these dates.
Featured Speaker
Mustafa Edik is Founder and Lead Consultant at Quality Academia Eğitim & Danışmanlık. He has over 28 years of experience in GMP, GDP, GCP, GLP, and broader GxP compliance across the pharmaceutical, biotechnology, and medical device industries.
- Credentials: Turkey's first IRCA-certificated Lead Auditor for GMP and Pharmaceutical Quality Management Systems. He holds a BSc in Chemistry, a BSc (Hons) in Biopharmaceutical Sciences & Engineering from Atlantic Technological University (Ireland), and an Executive MBA. Bayer Türkiye: Progressed from Quality Control Lab Supervisor to Deputy QA Manager and Global GMP Lead Auditor. Audits and training: Has led more than 4,200 hours of GxP audits across over 200 facilities worldwide and trained over 9,000 professionals in GxP topics. DCVMN: First Turkish consultant selected by the Developing Countries Vaccine Manufacturers Network (DCVMN). Publications: Author of "GMP Audits in Pharmaceutical and Biotechnology Industries" (Taylor & Francis / CRC Press, June 2024).
To reserve a place on "GMP Advanced Masterclass for Pharmaceutical and Biotechnology Industries," register your interest directly through Research and Markets at:
For more information about this training visit
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