The pharmaceutical industry is undergoing a significant transformation driven by digitization and artificial intelligence (AI). As regulatory expectations from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to emphasize data integrity, traceability, and compliance, Good Manufacturing Practice (GMP) systems must evolve accordingly.

Stakeholders’ Consultation on EudraLex Volume 4 -
Good Manufacturing Practice Guidelines:
Chapter 4, Annex 11 and New Annex 22

Revision of Good Manufacturing Practice (GMP) Guidelines Chapter 4 (Documentation), Annex 11 (Computerised Systems) and New Annex 22 (Artificial Intelligence)

Mid-Year Reflections in Pharma

1. Review Regulatory Changes & Updates
   Take stock of the latest industry shifts—FDA guidance, QMSR, AI/ML, LDT oversight, EU MDR/IVDR. Are you and your team adapting your processes and documentation accordingly?
2. Assess Progress Toward Annual Goals
   Check your scoreboard: Which milestones have you nailed, and what targets could use a second wind in the months ahead?
3. Identify New Skills & Knowledge Needed
   With digital transformation accelerating, what additional expertise or certifications could help you—or your team—lead the way?
4. Revisit Team Communication and Collaboration
   Has your approach to handovers, remote work, or team check-ins kept pace with your changing projects? A small tweak now can mean less scramble later.
5. Capture Lessons Learned From Challenges
   Think back on hurdles—unexpected audits, tech hiccups, or evolving compliance demands. Jot down what worked well (or not so well) to future-proof your processes.

Sterility Assurance University
Advancing Microbiology, CCS, Cleaning Validation, EM & Digital Tools Across the Lifecycle
August 5-6 | Attend Virtually or Philadelphia, PA

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MedTech Innovation & Validation University

AI-Powered Validation – QMSR Readiness – CSA in Practice – Cybersecurity Risk
October 8-9 | Attend Virtually or La Jolla, CA


GMP University

Modernizing GMP Processes from Risk to Inspections

October 8-9 | Attend Virtually or La Jolla, CA

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We have spent the past three decades on an epic ride through the life science industry. With early beginnings in the FDA and globally-regulated environment, we understand the importance of exchanging knowledge to make drugs and devices safer, and equipment and processes more scientifically sound. In the end, exchanging knowledge not only improves lives, but also saves them.

Whether you attend one of our interactive conferences or webinars, or take advantage of our valuable free process documents; our goal is to provide tools and techniques that will have an instant impact on your core responsibilities.