This course discusses the Official ICH Q7 API GMP Guidance that was accepted by the US FDA as also accepted by the EU and Japan. This Active Pharmaceutical Good Manufacturing Practice has received acceptance on a truly international basis. This program, as presented, provides the participant with a “Snapshot” of the 19 Section Guidance with a special focus on Key Sections that, in the opinion of the presenter, discusses specific parts that warrant special recognition based upon important issues that must not be overlooked by the industry or regulators.
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