GMP Update & Latest Trends

Topics Covered:

• EU regulatory updates: Annex 1 implementation, Annex 11 draft (data integrity & computerized systems), CCS expectations, and EMA Q&As
• FDA trends: Top 483 citations, validation enforcement, CMO oversight, and the QMM program
• ICH & PIC/S news: Analytical lifecycle (ICH Q14, USP <1220>), and global harmonization initiatives
• Authority inspection focus areas: MHRA, DKMA and FDA warning letter insights
• Current risks and pitfalls: Remote batch certification, change control, deviations, data integrity

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Course Objectives

Participants will learn how to:  

• Get up to speed with current GMP regulations (EU/FDA/ICH/PIC/S)
• Understand what authorities are focusing on now
• Identify trends that may impact your inspections and QMS
• Strengthen your compliance strategy for 2025

Target Audience

This course is ideal for:

GMP professionals in QA, QC, Regulatory Affairs, Manufacturing, Validation, andInspection Readiness.

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Meet your instructor‍

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Per H. Damgaard

Dr. Per H. Damgaard is Vice President for Training, Education & Audit at Epista.

Led by oneof the industry’s most respected voices in compliance, Dr. Per H. Damgaardbrings decades of experience in GMP training, regulatory inspections, andquality assurance across the life science industry.

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