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In light of the pandemic situation events until September 2021 are cancelled. We will inform customers directly when the events are rescheduled.    
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Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .    
TENTATIVE: 21 CFR Part 11 Compliance,   Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance,   Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation,   Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021,   Boston MA, Dec 7-9, 2021

Boston Professional Events List


2 Hrs Live Webinar Moving from GMPs to the Pharmaceutical


Date
Oct 05, 2021 - 01:00 PM - Oct 06, 01:00 PM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

Description

Overview

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.


 

Session Highlights

  • 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


     

Who Will Benefit

  • Personnel involved in the production and control of pharmaceutical products

  • Pharmaceutical development

  • Unit managers

  • Senior managers in the pharmaceutical industry


     



Speaker Details


Speaker

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

Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]


Event Categories
Keywords: pharmaceutical




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