Thursday 4th April, 2013
10:00am to 11:30am
Overview: This webinar will define the concepts behind the application of the Quality systems to drug operations and the specific elements as discussed on the ICH Q-10. The course will include specific discussions on the enablers for the QS implementation and on each QS element from a risk-based approach so that the specific requirements can be prioritized based on the highest impact to product quality and this prioritization scheme can be applied during the implementation. The specific requirements to be addressed in detail include: CAPA, Internal Audits and Change Control. As a result, an effective plan for compliance can be developed and executed.
Why should you attend: These guidelines have been effective since 2006 and 2009 respectively and many companies are still struggling on how to implement these requirements effectively. They may have Change Control, CAPA, Internal Audits but these are not being executed with positive concrete results.
Areas Covered in the Session:
Q10 Enablers and their applications
Course Modules & Content Details:
Regulatory Background - FDA guidance and ICH Q10
Why A Harmonized Approach to a Comprehensive, Modern and Robust Quality System? Why Q10?
ICH Q-10 Enablers and their importance
ICH Q-10 elements and their role:
Quality Manual - Policy, Quality Plans and Management Role
Management Responsibility as "Ultimate Responsible for QS" - Commitment, Quality Policy, Planning, Resources, Communication and Review
Continual Improvement of Process Performance and Product Quality - Monitoring, CAPA, Change Management and Management Review
Continual Improvement of the Pharmaceutical Quality System - Internal Audits
Who Will Benefit:
Miguel Montalvo, B.S. Chem. Eng., MBA, President, Expert Validation Consulting, has over twenty-eight years of professional/management experience in positions of increasing responsibility in the areas of Quality, Validations and Technical Services within the traditional pharmaceutical, OTC Drugs, cosmetics, dietary supplements, biotechnology.
Livermore Common, Fremont, CA, 94539
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4th April 2013