Upcoming Seminars

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24th & 25th October, 2019
  • Philadelphia, PA
  • 9:00 AM to 6:00 PM
  • Susanne Manz

Death by CAPA - Does your CAPA Program need a CAPA?

This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance.

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4th & 5th November, 2019
  • San Francisco, CA
  • 9:00 AM to 6:00 PM
  • Angela Bazigos

What Good is Bad Data? Best Practices for Achieving Data Integrity Using 21 CFR 11, Annex 11 & Computer Systems Validation (CSV)

Data integrity is defined as the extent to which all data (whether electronic or paper-based) are complete, consistent, accurate, trustworthy, and reliable throughout the data lifecycle—from creation through archival status and their eventual destruction.

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14th & 15th November, 2019
  • New Orleans, LA
  • 9:00 AM to 6:00 PM
  • Brian L Tuttle

HIPAA 2019 and Beyond

This two-day seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA HITECH is now fully enforced with bipartisan support and the government is not using kid gloves any more.

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14th & 15th November, 2019
  • Philadelphia, PA
  • 9:00 AM to 6:00 PM
  • Teri C Soli

The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems.

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4th & 5th December, 2019
  • Washington, DC
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

FDA and U.S. Customs Import Rules and Export Traps in 2020

FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an import and export program find their shipments delayed, detained or refused.

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30th & 31st January, 2020
  • Boston, MA
  • 9:00 AM to 6:00 PM
  • Casper Uldriks

Critical Issues for Medical Devices in 2020

The FDA's device regulation has begun to make your regulatory life easier. Can you qualify for an easier way of life under FDA regulation? Getting to market with a new device could be totally under your control and keep FDA out the premarket hurdle. On the other hand, the EU's new Medical Device Regulation (MDR) will make it more difficult.

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