Moving from GMPs to the Pharmaceutical Quality System

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 120 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 120 mins Live Webinar

"John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System"

Firm must implement to be compliant with the CGMPs

Description

Since the turn of the century, the FDA has been promoting the idea of a Pharmaceutical Quality System. This is supported by an FDA Guidance Document: Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations and ICH Q10; the Pharmaceutical Quality System. It is clear from FDA Form 483, Report of Observations given to pharmaceutical manufacturers and Warning Letters that the FDA is interpreting the GMPs (21CFR211) consistent with concepts found in ICH Q10; The Pharmaceutical Quality System. In this audio seminar we will discuss the systems that a firm must implement to be compliant with the CGMPs which is actually an implementation of the Pharmaceutical Quality System.

Areas 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
•     Recent FDA observations that demonstrate transition to the Pharmaceutical Quality System
•     How to prevent observations
•     Evolving GMP interpretations

Objective

 The objective of tis webinar is to educate individuals within the pharmaceutical industry of the impact ICH Q10, the pharmaceutical Quality System will have on the way we manage compliance in the coming years.

Who will Benefit

•     Personnel involved in the production and control of pharmaceutical products
•     Pharmaceutical development
•     Unit managers
•     Senior managers in the pharmaceutical industry

Industries who can attend

This 120-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

John G. Lanese

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. 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 year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry

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