Vishal Sharma, MS Vienni Training & Consulting LLP

Masters in Microbiology (M.Sc) with over two decades of experience in working in pharmaceutical manufacturing companies & consulting. Six Sigma green belt certified by Indian Institute of Statistics. Participates in and leads the initiatives of Parenteral Drug Association India Chapter as a founding member, a chapter board member and step up as PDA India Chapter President in January 2022.

• Volunteer for PDA Journal Science  & Technology as reviewer for articles on sterilization and sterility assurance.
• Member of a PDA Task force, contributing to the points to consider (PTC) for remote inspections/audits. PTC's are peer reviewed by various global regulatory agencies.

Exposure to and experience in the quality control/assurance functions in Microbiology &  with exposure of facing regulatory audits, exposure to sterile manufacturing for small molecules & Sterile API, designing & validating aspects/sterilization processes for products for global market. Handled the validation laboratory establishments & functioning for filtration & validation, excels in trouble shooting, especially in the aseptic area, microbiology & sterilization using statistical approaches. Consults, trains and educates sterile parenteral manufacturing teams, engaged in operations.