Course Overview

(An IRCA Certified Pharmaceutical QMS Auditor/Lead Auditor Course. Price:£2,750.00(excl VAT-discounts may be available).The 1st independently certified pharmaceutical GMP auditor course available across Europe.In the last year alone we have seen further significant changes and additions to pharmaceutical legislation and guidelines that will all have a major impact on how we do business – these include: FDASIA (Food and Drug Safety and Innovation Act) in the USA - Further enabling and clarification of the FMD (Falsified Medicines Directive) in Europe - Updated GMP guidelines that reflect the increasing impact and implementation of ICH Q10 (Pharmaceutical Quality System) - Draft guideline from the EC on GMP Risk Assessment for Excipients - And there will be more to come… The success of your company in meeting current expectations will depend significantly on the quality of your audit and self-inspection system, and in the competence, professionalism and decision making of your auditors.

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