This 90-minute session will provide professionals with a forward-looking perspective on the FDA’s compliance priorities in 2025. Attendees will gain practical insights to refine internal audits, strengthen CAPA systems, address risk-based enforcement, and prepare for evolving U.S. and international regulatory expectations.

After this webinar attendees will be able to answer-

• How to interpret FDA’s most recent Inspectional Observations and Form 483 findings
• What the FDA means by “risk-based” compliance and how it impacts daily operations
• How to address deficiencies in CAPA and trending
• What the new Device cGMPs – QMSR mean for manufacturers
• How to meet FDA’s cybersecurity expectations
• How FDA enforces 21 CFR Part 11 requirements for electronic records and signatures
• Why Warning Letters are being issued faster and what triggers them
• How AI/ML frameworks are being evaluated for drugs and devices
• What Total Product Life Cycle (TPLC) and Predetermined Change Control Plans (PCCPs) mean in practice
• How FDA’s push for “Better Science” affects compliance strategy
• How to adapt to overseas changes such as EU’s MDD to MDR transition and ISO 13485 harmonization

This webinar benefits the following agencies-

• Pharmaceutical, Medical Device, and Combination Product Manufacturers
• Regulatory Affairs Consultants
• Combination Products Manufacturers / Assemblers
• All companies selling medical devices or combination products in the U.S.

Who should attend?

• Senior Management in Medical Products Industries
• QA/RA Professionals
• IT & Cybersecurity Teams
• R&D, Engineering, Production & Operations Teams
• Regulatory Affairs Consultants
• Anyone responsible for FDA-regulated product compliance, manufacturing, or submissions