Upcoming Seminars

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

Tougher Import Rules for FDA Imports in 2019

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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16th & 17th April, 2019
  • Philadelphia, PA
  • 9:00 AM to 6:00 PM
  • Peggy Berry

Seminar on Phase I GMPs

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required.

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18th & 19th April, 2019
  • Miami, FL
  • 9:00 AM to 6:00 PM
  • Brian L Tuttle

HIPAA 2019 - What's new?

This two-day seminar will get into the fine details of what we need to do and how to do it. We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy.

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18th & 19th April, 2019
  • Boston, MA
  • 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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23rd & 24th April, 2019
  • Philadelphia, PA
  • 9:00 AM to 6:00 PM
  • Dr 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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27th & 28th June, 2019
  • Baltimore, MD
  • 9:00 AM to 4:30 PM
  • Casper Uldriks

FDA Scrutiny of Promotion and Advertising Practices

If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances.

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