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 for both small molecule (pharmaceuticals) and Biologic products.  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. 

Steven A. Ostrove Ph.D.

Specialties: Regulatory, R&D

Steven A. Ostrove, Ph.D., has been involved in the Bio-Pharmaceutical business for over 35 years and is an invited course leader, lecturer and guest speaker for both national and international conferences.

In 1999, he opened Ostrove Associates, Inc. (OAI) – a validation, compliance and regulatory-affairs consulting company – to provide consulting services to both major pharmaceutical/biotechnology companies and small, start-up companies.

Previously, Dr. Ostrove worked as Senior Technical Specialist in the Technical Service Department of Pharmacia Biotechnology. He also served as Senior Director of Validation and Regulatory Affairs with a number of major design/build engineering companies.

In addition, Dr. Ostrove has also served as an adjunct professor of Pharmaceutical Engineering for Validation and Regulatory Affairs for the New Jersey Institute of Technology and as an adjunct professor of Biology for Kean College. He recently served as industry representative on an FDA advisory panel and as Acting Manager of Validation for a contract pharmaceutical/OTC manufacturer.