Richard Denk, Skan AG - Qepler's Highly Potent APIs Summit 2019

Richard Denk

Head of Sales Containment
Skan AG
Munich, Germany
Skan AG

Richard Denk has studied mechanical engineering and did examination on Experts of GMP, Qualification and Validation, Pharmaceutical Auditing, Pharmaceutical Engineering, Quality Control on the University of Applied Sciences in Albstadt/Sigmaringen Germany.

Richard Denk is working at the company SKAN AG, headquartered in Allschwil CH in the position Head Containment. Mr. Denk founded 10 years ago the expert Containment group CoP of the ISPE D / A / CH. The ISPE CoP Containment published the ISPE Containment Manual in September 2015.

The ISPE Containment Manual does provide a full overview on Containment. Furthermore, Mr. Denk is author at Maas & Peither GMP Publishing on containment and hygienic design and one of the authors of the ISPE Oral Solid Dosage Baseline Guide Volume 2 and Volume 3. Mr. Denk has spent more than 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

Related Sessions:

Pharmaceutical Lyophilization
Summit 2019

Discuss best practices in tech & regulatory updates, process, formulation, testing, monitoring and new products development.
  • 13 Feb 2019
  • Prague, CZ
  • Pharma
Day 2: Thursday 14, February 2019
BLOCK: LYOPHILIZATION OF NOVEL PRODUCTS.
CASE STUDY: GMP and Occupational Safety Requirements for Lyophilization of high potent/toxic substances.
  • What are high potent/toxic substances
  • GMP Requirements for high potent/toxic substances
  • Cleaning and Cross Contamination Requirements for Lyophilization based on the PDE (Permitted Daily Exposure)
  • Occupational Safety Requirements
View Details

Highly Potent APIs
Summit 2019

Assess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.
  • 20 Feb 2019
  • Berlin, DE
  • Pharma
Day 1: Wednesday 20, February 2019
BLOCK: APPLYING NEW REGULATIONS & GUIDELINES: ADOPTING TO THE REGULATORY LANDSCAPE.
CASE STUDY: GMP and Occupational Safety Requirements for highly potent aseptic processing.
  • How does GMP and Occupational Safety fit together?
  • What are Cross Contamination requirements in shared facilities?
  • Cleaning requirements and limits for non-product contact surfaces.
View Details