Live Webinar on Shared Facilities and the Move to Science Based Risk Assessments by Compliance2go
The lecture covers the topic of perception and reality. To be able to show science in risk assessment it has been necessary to design experiments to gather data to allow occurrence to be set in a risk assessment. This use of data has revealed some very interesting anomalies which are discussed.
Houston, TX, May 05, 2013 --(PR.com)-- Why should you attend :
Any one involved in shared or multi product facilities, Operations, Compliance, Quality, Engineering etc: The cGMP's governing shared facilities are rapidly changing to a science and risk based approach. This will fundamentally change the approach to Hormones, Cytotoxic materials, and Highly potent drugs. It ushers in the age of health based limits PDE, ADE ADI and the end of dose based limits.
Description of the topic :
The lecture covers the topic of perception and reality. To be able to show science in risk assessment it has been necessary to design experiments to gather data to allow occurrence to be set in a risk assessment. This use of data has revealed some very interesting anomalies which are discussed.
Webinar Includes:
-Q/A Session with the Expert to ask your question
-PDF print only copy of PowerPoint slides
-90 Minutes Live Presentation
-Certificate of Attendance
Areas Covered in the Session:
Facility Design, HVAC, Equipment selection; Cleaning, and Gowning; Products and Processes
Who will benefit: (Titles)
Quality professionals
Compliance professionals
Operations management
CMO business development professionals
Cleaning specialists
HVAC specialists
About Speaker
Julian Wilkins is founder and Vice President with PharmaConsult US, Inc. In 1991 he founded a UK based isolator company for the emerging need for pharmaceutical containment. The company carried out many projects worldwide for aseptic and potent cross contamination and containment at all scales of pharmaceutical operation. He moved to the US in 1997 and set up PharmaConsult US in 1999. Since its formation, the company has provided independent advice, design and support for patient safety (cross-contamination regulatory and quality issues) and occupational safety (containment) projects including Bristol-Myers Squibb, Chiron, GSK, Merck & Co., Pfizer, Roche Colorado, Sanofi Sythelabo, Tyco/ Mallinckrodt, Teva and Wyeth. Wilkins is also an adjunct professor at Steven’s Institute in the Pharmaceutical Manufacturing Engineering Master’s program. Wilkins is a core team member of the Risk-MaPP Baseline® Guide team. Wilkins is a past recipient of the prestigious ISPE Member of the Year award. Mr. Wilkins has spoken at many seminars worldwide on the subject of containment and has contributed articles and chapters to periodicals and books on cross contamination and containment.
Any one involved in shared or multi product facilities, Operations, Compliance, Quality, Engineering etc: The cGMP's governing shared facilities are rapidly changing to a science and risk based approach. This will fundamentally change the approach to Hormones, Cytotoxic materials, and Highly potent drugs. It ushers in the age of health based limits PDE, ADE ADI and the end of dose based limits.
Description of the topic :
The lecture covers the topic of perception and reality. To be able to show science in risk assessment it has been necessary to design experiments to gather data to allow occurrence to be set in a risk assessment. This use of data has revealed some very interesting anomalies which are discussed.
Webinar Includes:
-Q/A Session with the Expert to ask your question
-PDF print only copy of PowerPoint slides
-90 Minutes Live Presentation
-Certificate of Attendance
Areas Covered in the Session:
Facility Design, HVAC, Equipment selection; Cleaning, and Gowning; Products and Processes
Who will benefit: (Titles)
Quality professionals
Compliance professionals
Operations management
CMO business development professionals
Cleaning specialists
HVAC specialists
About Speaker
Julian Wilkins is founder and Vice President with PharmaConsult US, Inc. In 1991 he founded a UK based isolator company for the emerging need for pharmaceutical containment. The company carried out many projects worldwide for aseptic and potent cross contamination and containment at all scales of pharmaceutical operation. He moved to the US in 1997 and set up PharmaConsult US in 1999. Since its formation, the company has provided independent advice, design and support for patient safety (cross-contamination regulatory and quality issues) and occupational safety (containment) projects including Bristol-Myers Squibb, Chiron, GSK, Merck & Co., Pfizer, Roche Colorado, Sanofi Sythelabo, Tyco/ Mallinckrodt, Teva and Wyeth. Wilkins is also an adjunct professor at Steven’s Institute in the Pharmaceutical Manufacturing Engineering Master’s program. Wilkins is a core team member of the Risk-MaPP Baseline® Guide team. Wilkins is a past recipient of the prestigious ISPE Member of the Year award. Mr. Wilkins has spoken at many seminars worldwide on the subject of containment and has contributed articles and chapters to periodicals and books on cross contamination and containment.
Contact
Compliance2go
Jay Syvester
877-782-4696
https://compliance2go.com/index.php
Jay Syvester
877-782-4696
https://compliance2go.com/index.php
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