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15.05.2021

GMP Biotech Summer School



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 will develop GMP compliant solutions (e.g. risk assessments, equipment qualification) together with the trainer.

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; Licence Application; Computerized Systems; Data Integrity.

Duration:

The qualification will comprise a total of 80 lessons which will be held from Tuesday, 14 September 2021 to Wednesday, 22 September 2021, daily from 9:00 a.m. till 06.00 p.m., excl. Sunday, 19 September 2021. Please note, Saturday, 18 September 2021 is a regular course day.

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.


» Programmdetails und Anmeldung


Veranstalter:
Gläsernes Labor Akademie
Typ und Ort:
Lehrgang (Berlin-Buch)
Termin:
14. - 22.09.2021
Land:
Deutschland

Kontaktdaten:
Gläsernes Labor Akademie
Campus Berlin-Buch GmbH
Robert-Rössle-Straße 10
D-13125 Berlin

Tel.: +49 30 9489-2935
Fax: +49 30 9489-2927
Mail: Anfrage versenden
Web: www.glaesernes-labor-akademie.de