Upcoming Seminars

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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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19th & 20th March, 2020
  • SFO, CA
  • 9:00 AM to 6:00 PM
  • Heath Rushing

Applied Statistics for Scientists and Engineers

Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis,

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23rd & 24th April, 2020
  • 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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