Workshop 2 – Biotech Quality Manager
ABSTRACT
The workshop will illustrate business activities in quality management in pharma and medical device industry. The job of a quality manager represents a popular access position to industry since legal GMP requirements are constantly increasing and need for quality managers is equally emerging.
TARGET GROUP & CONTENT
Quality management in pharmaceutical industry is one of the central control instruments for providing robust and safe drugs constantly. Quality managers daily deal with challenges in routine manufacturing of pharmaceuticals and medical devices which derives from unexpected deviations and intended changes which may have an influence on the stability of the product. Authorities such as the US FDA (Food and Drug Administration) will inspect German companies as soon they intend to export pharma products to the United States. These audits concentrate on quality management aspects and may result (worst case) into a warning letter that in turn is published on the FDA website and will reveal all deficiencies to your customers and competitors. Because of that quality managers possess a responsible role in this context. This workshop will provide an overview of central tools in quality management together with case studies from real life in order to prepare participants for strict audits by international authorities that decide about permission of marketing in corresponding country. An interactive role play will put the participants into the role of an FDA inspector who has to deal with authentic FDA findings from former inspections at pharmaceutical companies worldwide.
TIMELINE
09:00 – 10:30 INTRODUCTION / ISO GUIDELINE FOR QUALITY
10:30 – 10:45 COFFEE BREAK
10:45 – 12:00 TOOLS FOR QUALITY MANAGERS IN INDUSTRY
12:00 – 13:00 LUNCH BREAK
13:00 – 13:45 APPLIED GMP – MODIFICATIONS OF GMP-FACILITIES
13:45 – 14:30 APPLIED GMP – NON-CONFORMITIES AND ESCALATIONS
14:30 – 15:30 LEAN SIX SIGMA – TOYOTA CONCEPTS IN PHARMA
15:30 – 15:45 COFFEE BREAK
15:45 – 17:00 FDA FINDING SIMULATION
Date: Thursday, 10th December 2020 (fully booked out)
Duration: 1-day Online Workshop (via Zoom)
No. of participants: 15
Target group: PhD students
Challenge leaders: Dr. Christian Grote-Westrick
Credit points for participation: 2 HE