2021 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
Biotechnology Manufacturing Facility Design Training Course
7 - 8 June 2021
Using case studies and exercises this online live course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products.
Instructors
GAMP® 5, Annex 11/Part 11 Basic Principles
8 - 10 June 2021
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.
Instructor
ICH Q7A GMPs for Active Pharmaceutical Ingredients
14 - 16 June 2021
This course covers areas in which compliance requirements differ most from traditional pharmaceuticals and biologics and will review common deficiencies and problem areas related to the ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7 and the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
Instructor
Process Validation
14 - 16 June 2021
Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry.
Instructor
GAMP® 5 GxP Process Control
15 - 16 June 2021
This online 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. The course covers both regulated company and supplier quality management systems and the full system life cycle from concept to retirement.
Instructor
Pharma Facilities Project Management
22 - 23 June 2021
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.
Instructor
GMP Fundamentals for the Pharma Industry
28 - 29 June 2021
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. They will examine and discuss the process of a regulatory inspection and gain valuable insight into the compliance auditing process.
Instructor