2023 ISPE June 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® 5 GxP Process Control
6 - 7 June 2023
The course covers recommended good practice based on a lifecycle approach for the development and management of process control systems and shows how the principles and concepts of GAMP 5 may be practically applied to process control systems. It looks at the data created by the process control system through the data lifecycle to understand how to protect against threats to data integrity. The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement.
Instructors
GAMP® 5, Annex 11/Part 11 Basic Principles
6 - 8 June 2023
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.
Instructor
Winnie Cappucci
Retired
GMP Fundamentals for the Pharmaceutical Industry
7 - 8 June 2023
This course is designed to help participants understand the GMPs as they relate to the pharmaceutical industry. Participants will gather information about both European regulators and the FDA, how the various agencies enforce GMP requirements, and what to expect during a routine GMP inspection.
Instructors
Overview Biopharmaceutical Manufacturing Processes
13 - 16 June 2023
Explore commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography.
Instructors
Pharma Facilities Project Management
14 - 15 June 2023
This course is structured around a typical facility project lifecycle of Project Initiation, Delivery Planning, Design Planning and Delivery, Procurement, Construction, Commissioning and Qualification and Project Close-Out & Review and uses case study examples throughout to illustrate key points.
Instructors
GAMP® Data Integrity 21 CFR Part 11 Training Course
21 - 23 June 2023
This 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 to ensure the integrity and validity of the information throughout the data lifecycle.