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ISPE D/A/CH YP Webinar: High Potency Drugs – An Introduction to Innovative Containment Solutions
April 6, 2018 @ 12:00 am
High Potency Drugs – An Introduction to innovative containment solutions
by Richard Denk
What? – free webinar
When? – 9.may 2018, 9:30-11:00 am (CET)
„The use of dedicated production areas should also be considered when material of an infectious nature or high pharmacological activity or toxicity is involved […] unless validated inactivation and/or cleaning procedures are established and maintained. Appropriate measures should be established and implemented to prevent cross-contamination from personnel and materials moving from one dedicated area to another.“ (FDA Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients)
In the course of the growing market for highly active and hazardous pharmaceutical products, reliable and robust containment solutions take on greater significance. The scope of containment has risen from industrial safety to topics such as cleaning validation and cross-contamination. The ISPE Community of Practice: Containment (CoP containment) has published a full-scope Containment manual, which is used by over 500 experts in the field and is therefore one of the most successful official ISPE documents.
In the ISPE D/A/CH Emerging Leaders Webinar, Richard Denk – founder and chair of the CoP containment – will introduce you into the basics such as classification, regulatory requirements and possible technical concepts. An overview of advanced technical solutions applied in drug development will finally give you an impression of the complexity and necessity of those systems.
Additional information on Richard Denk:
Richard Denk is Head of Sales Containment at SKAN AG, headquartered in Allschwil, Switzerland. 10 years ago, he founded the expert group for containment CoP of the ISPE D/A/CH. In September 2015, the CoP Containment published the ISPE Containment manual, which is available in German and English.
Furthermore he is author at Maas & Peither GMP Publishing and ISPE Oral Solid Dosage Baseline Guide Volume 2 and Volume 3. In total, he spent nearly 20 years on subject production of highly active substances and has developed the classification containment pyramid.
If this could spark your interest, join us and Richard Denk on 9th May 2018 at 9:30am for our webinar.