Fremont, California (PressExposure) March 23, 2013 -- Description:
The ICH Q-10 guidelines, which have been in force since 2006, have specific instructions for application of drug operations. Quality Systems (QS), which have a great impact on the product quality, need to take CAPA, Internal Audits and Change Control into account. These have to be applied on a prioritization basis, but most organizations get this wrong.
This webinar will discuss how to implement a QS that takes all these elements into consideration. The ways of implementing these three specific requirements will be taken up for detailed analysis. The presenter will give clear hints about how to implement these critical aspects taking a Risk-based approach. Once this method is followed; the specific requirements of these can be prioritized depending on the highest impact each makes to the quality of the drug.
This session will include the following contents:
o Regulatory Background - FDA guidance and ICH Q10
o Why A Harmonized Approach to a Comprehensive, Modern and Robust Quality System? Why Q10?
o ICH Q-10 Enablers and their importance
o ICH Q-10 elements and their role:
o Quality Manual - Policy, Quality Plans and Management Role
o Management Responsibility as "Ultimate Responsible for QS" - Commitment, Quality Policy, Planning, Resources, Communication and Review
o Continual Improvement of Process Performance and Product Quality - Monitoring, CAPA, Change Management and Management Review
o Continual Improvement of the Pharmaceutical Quality System - Internal Audits
It will cover the following areas:
o Q10 Enablers and their applications
o Internal Audits
o Change Control
When:April 4, 10:00 AM PDT | 01:00 PM EDT
Miguel Montalvo, who has a B.S. in Chemical Engineering and an MBA, is President, Expert Validation Consulting. He has over 28 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 and medical device industries.
He is a well-recognized international speaker on GMP Compliance, Validation and Quality related topics. He is a member of the Journal of Validation Technology editorial board and of the PDA Annual Program Committee for their Annual meetings.
The webinar will benefit professionals in
o Top Management
Duration: 90 minutes
To enroll for this webinar, contact