Upcoming Seminars

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  19 Jun 2025, 10:00 am GMT-5 – 20 Jun 2025, 4:00 pm GMT-5

  Bottlenecks to Flow: Optimizing Design Controls and Validation in Medical Device QMS / 

  Virtual Events

  Complete Information

  19 Jun 2025, 10:00 am GMT-5 – 20 Jun 2025, 4:00 pm GMT-5

  Virtual Events

  Faculty: JOSÉ MORA Medical device manufacturers face growing challenges in design controls, process validation, and regulatory compliance, often leading to inefficiencies, redundancies, and compliance risks.
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  12 Jun 2025, 10:00 am GMT-5 – 13 Jun 2025, 3:00 pm GMT-5

  Implementing CSA for GxP Systems - Transition, Documentation, and Post-Transition Challenges and Opportunities / 

  Virtual Events

  Complete Information

  12 Jun 2025, 10:00 am GMT-5 – 13 Jun 2025, 3:00 pm GMT-5

  Virtual Events

  Faculty: CAROLYN TROIANO | June 12 - 13, 2025 |Time: 10 AM to 3 PM The transition to Computer Software Assurance (CSA) marks a pivotal shift in the approach to compliance for FDA-regulated industries.
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  13 May 2025, 10:00 am GMT-5 – 14 May 2025, 4:00 pm GMT-5

  The DHF, Technical Documentation - Similarities, Differences and the Future / 

  Virtual Events

  Complete Information

  13 May 2025, 10:00 am GMT-5 – 14 May 2025, 4:00 pm GMT-5

  Virtual Events

  Faculty: JOHN E. LINCOLN | Date: May 13 - 14, 2025 | Time: 10 AM to 4 PM This seminar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR, and DHR.