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Process Validation for Drugs and Biologics

 
  July 03, 2014  
     
 
Center for Professional Innovation & Education, Inc., Malvern, PA
Oct. 20 & 21, 2014


The application of Process Validation is becoming an increasingly important activity for pharmaceutical and biotech organizations given the critical role validated processes have in ensuring product conformance.   To assist industry, several guidances have been developed by regulatory agencies in the last few years that define the requirements and best practices for the effective implementation of Process Validation. 

Organizations that fail to develop an effective process validation system will face significant regulatory consequences including For Cause audits by regulators, recalls or plant closure.  However, the application of process validation is not limited to the manufacturer; it also extends to include suppliers.  Regulations have been established which direct organizations to assess the adequacy of process validation activities at their suppliers.  For example, regulators expect organizations to begin process validation activities before new equipment is installed.

This course, entirely updated to reflect the current requirements and guidances published by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, the European Medicines Agency , FDA and International Conference on Harmonization, will provide participants with a thorough understanding of the requirements of process validation.  They will learn how to establish an effective process validation system and integrate it with other systems such as Risk Management, Corrective and Preventive Action and Supplier Management. 

Participants will learn how to develop rigorous protocols and reports, as well as create monitoring programs to ensure that defined critical parameters remain in control.  The course will also review validation requirements for systems that generate electronic signatures and records as most new processes have this capability.  

Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion. 

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers:

Gordon Wehner is President of QualMed. QualMed works with both small, entrepreneurial firms and large, well-established medical-device and pharmaceutical organizations regarding audits, gap assessments, Good Distribution Practices, WEEE, RoHS and Supplier Management in Canada, the United States and Europe.

With nearly 25 years of experience in Quality Assurance, Regulatory and Clinical Affairs in the medical device and pharmaceutical industries; Mr. Wehner has worked with organizations both small and large – including four start-up organizations – to improve or establish quality management systems.

Mr. Wehner has an in-depth understanding of Canadian, US and international regulations for medical devices and pharmaceuticals; including ISO 13485:2003, ISO 14971:2007 and FDA Quality System Regulations. This experience includes the European Medical Device Directive – as well as Canadian, US and International GMPs. He has been directly involved in several design and development projects that include the application of Risk Management and Process Validation.

Mr. Wehner received his MSc in Biology from the University of Waterloo and his HBSc in Biology and MBA in Operations Strategy from Wilfrid Laurier University. 

 
Deadline for Abstracts: n/a
 
Registration: CLICK HERE TO REGISTER
E-mail: info@cfpie.com
 
   
 
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