URGENT PANDEMIC INFORMATION
COVID CANCELLED: Project Management in Human Resources, Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference, Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers, Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies, Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training, Boston MA, Mar 3-5, 2021
COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop, Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training, Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods, Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s, Boston MA, May 10-12, 2021
COVID CANCELLED: SharePoint Technology Conference, Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program, Boston MA, Jun 7-9, 2021
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
Link to Website
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.
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
Senior managers in the pharmaceutical industry
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System.
(Contact us : 844-267-7299 | 954-947-5671
Don't wait. Register TODAY or Email US [email protected]
VIP Life Time Subscription to our Newsletters!