2024 ISPE December Online Live Training
Deep Dive into Pharma Training Courses
Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.
- Real World Practice: Courses present exercises that use current problems and situations common to the industry.
- Experienced Instructors: Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
- Global Training to Fit Your Needs: With eLearning
GAMP® Data Integrity 21 CFR Part 11
3 -5 Dec 2024
This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.
GAMP® 5, Annex 11/Part 11 Basic Principles
3 - 5 Dec 2024
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.
GMP Sterile Pharmaceutical Manufacturing Facility
3 - 6 Dec 2024
This course uses the second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities. The Guide provides valuable information on design, while the USFDA's Guidance helps professionals understand the regulatory context and expectations for sterile drug manufacturing.
ATMP Manufacturing
10 - 13 Dec 2024
This course is focused on the commercial manufacture of Advanced Therapy Medicinal Products (ATMPs) drug products in manufacturing facilities. The purpose of this course is to focus on facility engineering issues and how to provide cost-effective facilities to ensure that products of the highest quality are consistently manufactured, as defined in the new Good Practice Guide.
Pharmaceutical Water Systems
10 - 12 Dec 2024
This course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP, EP and non-compendial waters will be covered.