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August 2018

Out-of-Specifications (OOS)/Out-of-Trend (OOT) Investigations for Analytical Testing

August 23 - August 24

POSTPONED - New Dates Coming Soon! One and a half days interactive presentation, case studies, exercises and workshop. Deficiencies of Out-of-Spec (OOS) investigations continue to be the major cause of warning letters in the pharmaceutical industry.  FDA requires that all out-of-specification results must be investigated; therefore, an effective and compliant quality management system requires well-documented, thorough investigations for OOS.  Key challenges for many companies are having a clear understanding of regulatory expectations on how to handle OOS investigations.  Lack of…

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October 2018

Keeping your analytical method in compliance with Good Manufacturing Practices (GMPs): Validation, Verification and Transfer

October 2 @ 8:30 am - 5:00 pm
Montreal, Canada Canada

One Day Interactive presentation, case studies and exercises: Analytical laboratories play important roles in the pharmaceutical industry. The generation of data under conditions that ensure its reliability and allow for post-analysis verification of its authenticity is critical to the drug development process; therefore, keeping the analytical method in compliance with validation requirements and product changes is a challenge for analytical scientists. This course will review the current regulations, provide updates from FDA, ICH, USP, and WHO, and different aspects of…

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2018 Annual GMP Update | BPF Mise à jour

October 3 - October 4
Montreal, Canada Canada

MARK YOUR CALENDAR for IPA's 2018 Annual GMP Update | BPF Mise à jour Conference! International Pharmaceutical Academy (IPA) is delighted to be hosting its 14th annual GMP Update | BPF Mise à jour 2018 on October 3-4, 2018 in the historical city of Montreal, Canada. The conference will provide attendees with insight and a plethora of information on quality, compliance, validation, and regulatory areas affecting the pharmaceutical, biopharmaceutical and allied industries. It will address compelling issues and the current…

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