Implementation of the ICH Q9 Guideline on Quality Risk Management
Instructor:
Miguel Montalvo
Product ID: 700236
Training Level: Intermediate to Advanced
- Duration: 60 Min
The Q9 Guideline will also represent a critical system component of the Quality Systems to be defined on the upcoming ICH Q10 Guideline for Quality Systems that has already been approved for development by the Steering Committee of the ICH. Quality Risk Management must be implemented by developing a general policy and the specific QRM plans for each aspect/area to have their risk analyzed. Formal risk management is not necessary for all risks - only for the more critical/higher impact on product quality.The course will include instructions on how to:
- Develop and implement a policy for a Quality Risk Management Program
- Determine how to select the direct-impact systems and processes to apply your policy - formal QRM
Areas Covered in the seminar:
:- History and Background of the ICH Efforts on Risk management
- Scope, Definitions and Basic Principles of Risk Management
- Application of the General Process Requirements for Risk management: Risk Assessment, Risk Control, Risk Communication and Risk Review
- Requirements for a "formal" risk management - Where/How to apply a formal QRM process?
- Specific applications and Case Studies
Who Will Benefit:
This webinar will provide valuable information for personnel in the following areas:
- Validations
- Manufacturing
- Quality Control/Assurance
- Engineering - Facility and Process
- Research and Development
- Materials Management
Mr. Miguel Montalvo, B.S. Chem. Eng., M.B.A., has over 23 years of valuable experience in the areas of cGMP compliance, quality and validation functions/responsibilities. He is the owner and President of Expert Validation Consulting, Inc, a firm specialized on focused and practical compliance and validation consulting for the pharmaceutical and OTC drug industry. He has been a frequent speaker/chairman at hundreds of validation and quality related conferences around the world for such groups as IIR, IVT, Barnett International and the CTFA and his articles/papers have been published in the American Pharmaceutical Review and the Journal of Validation Technology publications. He is a member of the Journal of Validation Technology editorial board.
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