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Validity : 13th Apr'24 to 23rd Apr'24
The Pharmaceutical Quality System: An element of Contemporary Compliance
The following areas will be covered:
- ICH Q10; The Pharmaceutical Quality System and how it impacts compliance to the CGMPs?
- The impact of ICH Q8; Pharmaceutical Development, ICH Q9; Quality Risk Management and the 2011 FDA Guidance on Process Validation
- Regulatory requirements vs. FDA expectations
- Recent FDA observations that demonstrate transition to the Pharmaceutical Quality System
- Evolving GMP interpretations
Overview of the webinar
The term Quality System began appearing in FDA publications and guidance about the turn of the century. In 2008 the FDA and ICH released ICH Q10, The Pharmaceutical Quality System and many of the FDA publications are based on the Quality System philosophy. Therefore, it is important that personnel in the pharmaceutical industry understand the Quality Philosophy and the impact this can and should have on policies and procedures that impact every-day activities in a pharmaceutical firm.
Who should attend?
- Quality Assurance in
1. Branded pharmaceutical firms
2. Generic pharmaceutical firms
3. Contract manufacturers
4. Contract laboratories - Senior Management
- Departmental managers
Why should you attend?
The regulation that currently applies is 21CFR211, Pharmaceutical GMPs which became effective in 1979. Although this is the current regulation, the FDA is emphasizing the Pharmaceutical Quality System and the systems that are a part of a contemporary quality system. Employees at all levels of the pharmaceutical industry should understand the systems that are a part of an effective quality system, realize that the GMPs are being interpreted within the Pharmaceutical Quality System and understand what is required for compliance within the context of an effective Quality System.
Faculty - Dr.Jerry Lanese
Jerry Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He lectures throughout the world and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of the year by the Journal of GXP Compliance. In 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry.