Good Manufacturing Practice (GMP) - Basic Course Biotechnology
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).
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 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.