Webinar ID:   ICT109

Risk Based Process Validation – Current International Trends

  90 Minutes

Categories:   Uncategorised,

International regulatory agencies like US FDA and EMEA have restructured the concept of ‘process validation’ into three stages namely ‘Process Design’, ‘Process Qualification’ and ‘Continued Process Verification’ during routine manufacturing. Thorough Process knowledge and understanding is the basis for establishing an approach to control the manufacturing process that results in products with desired quality attributes. Understanding the source of variation, detecting the presence & degree of variation and their impact on process as well as ultimately on product quality are the key requirements. This approach is expected to bring in an element of robustness into the manufacturing process and quality system.

This webinar will provide an overview of concepts and strategies for execution of the validation program based on risk approach in line with current expectation of international regulatory agencies.

Areas Covered in the Session :

  • Stages of process validation
  • Importance of thorough process knowledge
  • Quality life cycle concept
  • Process design
  • Process performance qualification
  • Differences between US FDA and other guidelines
  • Application of risk approach to process validation
  • Strategies to implement Continuous Process Verification stage
  • Protocols and report content

Who Should Attend:

  • Research and Development Departments
  • Engineering Departments
  • Quality Departments
  • Manufacturing Departments
  • Operations Departments
  • Production Departments
  • Document Control Professionals
  • Device Development Teams
  • Quality Auditors
  • Personnel involved in Verification and Validation planning


Dr. Ganesh Prasad

Dr. Ganesh Prasad is a Pharma consultant in India & holds a doctorate degree in Organic Chemistry from Indian Institute of Science, Bangalore. Previously, he worked at senior levels in pharmaceutical companies like Apotex Pharmachem India Pvt Ltd, ICI Pharmaceuticals, Chennai and other organisations heading QC/QA/Process functions. He has also worked as scientist in the US FDA laboratory at NIH campus and other reputed institutions in USA/ Canada. He has together more than 25 years’ experience in quality assurance function, research in academia and industry.

As a consultant he has assisted many pharmaceutical companies towards establishing cGMP standards complying with national and international standards and submission of Drug Master Files to various global regulatory agencies. Dr. Prasad is a life member of Indian Pharmaceutical Association and a former board member of ISPE (International Society for Pharmaceutical Engineers) India Affiliate, Hyderabad chapter.