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 industrial level.
This course 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 how regulatory requirements are transferred into practice.
The course will include some workshop elements where trainees together with the trainer develop GMP compliant solutions (e.g. risk assessments, equipment qualification).
According to local law (§ 11 Berliner Bildungsurlaubsgesetz BiUrlG) educational leave will apply.
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; Licence Application; Computerized Systems; Data Integrity.
The qualification will comprise a total of 80 lessons which will be held from Thursday, 15 Aug 19 till Friday, 23 Aug 19, daily from 9:00 a.m. till 06.00 p.m., excl. Sunday, 18 Aug 19.
The course is limited to a maximum of 20 participants and will only take place with a minimum of 5 attendees. Due to organizational reasons, an early registration is recommended.
The Course is directed to staff (Natural Scientists, PhD students and postdocs of natural scientific and medical degree programs; Technical Assistants and trained Laboratory Assistants with professional experience) having no or little experience with the current GMP requirements.
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.
The successful participation to be evaluated through a final multiple choice test will be certified by the German Pharmaceutical Industry Association (BPI) and by the Gläsernes Labor Akademie (GLA).
Laboratory experiences are advisable.
2.374,05 € per participant incl. VAT.
Private registrees will get a fee reduction of about 10 %.
Guest houses on the Campus can be found at: https://www.bbb-berlin.de/en/gaestehaeuser.html