ISPE In Person Training Courses

ISPE Online Live Training Courses


GAMP® 5, Annex 11/Part 11 Basic Principles

Submitted by Anonymous on Fri, 04/01/2022 - 11:30
Date
-

Orlando, FL
United States

Training Course
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. Please click the "Locations and Registrations" table to select the two or three-day sessions.

Science and Risk-based C&Q (T40)

Submitted by Anonymous on Fri, 04/01/2022 - 11:30
Date
-

Orlando, FL
United States

Training Course
Worldwide Regulatory expectations and guidance as led by FDA and the EU have stated that all Pharmaceutical Quality Systems should apply a QRM (Quality Risk Management) approach. Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.

GAMP® 5, Annex 11/Part 11 Basic Principles

First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on Wed, 07/20/2022 - 17:12
Date
-

Vienna 1010, %administrativeArea
Austria

Training Course
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements. Please click the "Locations and Registrations" table to select the two or three-day sessions.