image33

August 22 , 10.00 am IST

IMPLEMENTATION OF A C & Q STRATEGY

Implementation of a C & Q Strategy

Educational Session by Ankur Verma

About the Webinar

The webinar will cover aspects of planning a CQV strategy and deep dive into  aspects like what strategy one has to follow, when is the ideal time to start, which guideline one has to comply to and the steps to be followed.  The webinar will specifically discuss 


Evolution of CQV Approach over the years

What are various approaches for CQV available globally

What and Why is the confusion around the CQV Approach

How to choose a right approach for a greenfield and Brownfield facility

When to optimally plan and start CQV In the Project Life Cycle

How to use QRM implementation in the CQV cycle

What are the pitfalls we end up in during the CQV cycle

FDA citations 


About the presenter  Ankur Verma

Ankur is an experienced Biotechnology Engineer with close to 15 years’ experience . Started career in Downstream Processing where he worked specifically in Sterile Filtration and Filter Validations. After having worked in the Aseptic Process area he moved into Validation of Terminally Sterilized products. Trained in USA and worked on  Sterilization Validation, Terminal Sterilization, D Value Study of Parenteral, Sterilization GAP Analysis and Sterilization Process Optimization. After having worked in Validation Ankur moved into the field of Commissioning and Qualification wherein he worked as a Project Quality Manager for Fill Finish , OSD, API and Biotech  facility  for the C&Q of the same. He has also worked for a large Vaccine client for their C&Q project and for a Switzerland MNC API C&Q project. He is currently acting as SME on many OSD, Fill Finish , Biopharma facilities CQV Projects in Asia.

Ankur has been involved in GMP Gap Assessment and have been a trainer for GMP as well as Qualification and Validation. Led implementation of Risk Based and Hybrid Approach for Commissioning and Qualification for many projects. Was also briefly involved in the Control Strategy and have developed Risk Based Strategy for Process Support systems.