Richard Denk, Skan AG - Qepler Summits And Conferences

Richard Denk

Head of Sales Containment
Skan AG
Munich, Germany
Global market and technology leader for isolators, cleanroom equipment and decontamination processes for aseptic production.

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:

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

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
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3rd Annual Highly Potent
APIs Summit 2023

Assess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.
  • 22 Feb 2023
  • Virtual,
  • Pharma
Day 1: Wednesday, 22 February 2023
CASE STUDY: How to develop a high potent Antibody Drug Conjugate ADC production suite.
  • How to design the Containment from inside to the outside
  • Design criteria for high potent Aseptic Manufacturing
  • Cleaning requirements to prevent Contamination and Cross Contamination
View Details