Join the PDA Singapore Chapter for an evening discussion on Annex 1.
Goh Choon Wee is one of the Senior Compliance Audit Managers from Pharma Global Technical Operations Quality and Compliance Audits of Roche. Choon Wee carries out GMP and compliance audits on internal and contracts manufacturing sites, covering both commercial and investigational medicinal products and API. Choon Wee joined Roche since 2018, and previously, was a GMP inspector from Health Sciences Authority Singapore for 15 years. Currently, Choon Wee is one of the task force members in PDA to develop Standard for Cryopreservation of Cells Used in Cell Therapies and Regenerative Medicines.
Richard Denk has studied mechanical engineering and examined 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. Ten years ago, Mr. Denk founded 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 of Containment.
Furthermore, Mr. Denk is an 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 and published several PDA Scientific Documents for Preventing Cross Contamination. Mr. Denk is Steering Committee Member of the ISPE CoP SPP. Mr. Denk has spent more than 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.
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