ISPE In Person Training Courses

ISPE Online Live Training Courses


First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on Wed, 07/19/2023 - 14:31
GAMP Basic Principles (T07)
Date
-

Barcelona, Spain
Spain

Training Course

GAMP® Basic Principles 2-Day 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, by building upon existing industry good practice in an efficient and effective manner.
Submitted by Anonymous on Wed, 08/16/2023 - 10:00
Hands-On Aseptic Processing & Annex 1 and ATMP Manufacturing
Date
-

Strasbourg, France
France

Training Course

Hands-On Aseptic Processing & Annex 1 & ATMP Manufacturing Training

To meet the challenges of the new Annex 1 guidance while enhancing industry efforts to develop, manufacture, and reliably deliver quality medicines to patients, ISPE is conducting a 4-day interactive training event in a unique setting, the European Aseptic and Sterile Environment (EASE) Facility in Strasbourg, France. This training provides hands-on opportunities to interact with equipment in a facility built for training pharmaceutical industry workers. During the training sessions, attendees will have the opportunity to conduct aseptic processing steps as well as ATMP manufacturing exercises in the clean rooms at the EASE facility including preparation and aseptic manipulation inside biological safety cabinets.
First name
Trudy
Last name
Patterson
Submitted by Trudy Patterson on Wed, 08/16/2023 - 16:29
Science and Risk-based C&Q (T40)
Date
-

Vienna, Austria
Austria

Training Course

Commissioning and Qualification 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.
Submitted by Anonymous on Thu, 11/02/2023 - 14:07
GAMP® Basic Principles 2-Day Training Course
Date
-

Lisbon, Portugal
Portugal

Training Course

GAMP® Basic Principles 2-Day 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, by building upon existing industry good practice in an efficient and effective manner.
Submitted by Anonymous on Fri, 12/01/2023 - 13:07
APQ - Quality Maturity
Date
-

Boston, United States
United States