Good Manufacturing Practice (GMP) Basic Course Biotechnology (English) & ATMPs
Knowing and applying the Good Manufacturing Practice (GMP) regulations is one of the key elements in the manufacture of medicinal products for clinical trials and on an industrial level.
This online course based on Zoom concentrates on GMP requirements regarding biopharmaceutical and Advanced Therapy Medicinal Products (ATMP) manufacturing.
During the course, the most important elements of GMP will be explained in an easy-to-understand way with reference to the relevant GMP regulations and examples of how regulatory requirements are transferred into practice.
The course will include some workshop elements where trainees will develop GMP compliant solutions (e.g. risk assessments, equipment qualification) together with the trainer.
According to local law (Berliner Bildungszeitgesetz BiZeitG) the course can be classed as educational leave.
Topics:
History and Evolution of GMP; Regulatory Authorities (EU, US, Germany), GMP Regulations/ Guidance (Global, EU, US, Germany); Quality Systems; Documentation; Personnel; Premises; Equipment; ; Production: Basics; Production-Biologics: Up-stream, Down-stream, Fill&Finish; Production-ATMPs: Up-stream, Down-stream, Fill&Finish; Process Validation; Quality Control; Validation of Analytical Procedures; Inspections and Audits; Outsourced Activities; Investigational Medicinal Products; Clinical Trials; License Application; Computerized Systems; Data Integrity.
Duration:
The qualification will comprise a total of 80 lessons which will be held from Monday, 13 February 2023 to Wednesday, 22 February 2023, daily from 9:00 a.m. till 06.00 p.m., excl. Saturday and Sunday.
Size:
The course is limited to a maximum of 15 participants and will only take place with a minimum of 4 participants.
Target Audience:
The course is directed to natural scientists, PhD students and postdocs of natural scientific and medical degree programs, technical assistants and trained laboratory assistants with professional experience who have little or no experience with the current GMP requirements.
Learning Goals:
After course completion, attendees will have a thorough understanding of GMP basics as needed for the manufacturing of Biopharmaceuticals and ATMPs. Thus, based on their individual background, they should be able to identify potential occupational fields in the industry and authorities dealing with GMP topics.
Successful participation will be certified by the German Pharmaceutical Industry Association (BPI) and by the Gläsernes Labor Akademie (GLA).
Prerequisites:
Laboratory experiences are advisable.
Course fees:
1.942,00 € per participant plus 19% VAT.
Private applicants get a fee reduction of 10 %.
Further information:
Dr. Uwe Lohmeier per E-Mail: u.lohmeier@campusberlinbuch.de
Picture credits: Marc Voigt, Immutep GmbH
Version: 19 Jan 2023
Subject to modifications