Swapnil Ballal

Swapnil is a seasoned biotechnology professional with a solid multifunctional background and experiencein the bio/pharmaceutical industry with a major part of his career focused on operations/ manufacturing and quality assurance. He has been directly associated with more than 10 biopharmaceutcal products that are commercial production and several of them are approved in US/EU. He also has hands-on experience in Biologics/ Biosimilar and complex generics process development (CMC) and validation.

As Quality Assurance Head for two large Biopharma organizations, he has successfully led more than 50 international regulatory audits including EU-GMP, PIC/S, MCC SA, Russia, INVIMA, etc. Swapnil was also directly involved in designing/setup/ Project QA and refurbishing several medium to large scale facilities. He was also Co-Chair Of ISPE Disposables (Single Use) Community Of Practice and a contributor to ISPE Good Practice Guide- Single-Use Technology, Nov 18 and ISPE Baseline Guide:

Biopharmaceutical Manufacturing Facilities, 2nd Edition. Swapnil was also an ASQ Certified Quality Auditor (Dec 14-17).

By training, Swapnil is M.S. in Biotechnology. During his industry career, Swapnil worked as Development Scientist at Wockhardt and Intas Biopharma, Head of Biological DS production at Intas Biopharma and in QA leadership role with Biocon and Dr. Reddy’s. He also had a brief stint with GE Healthcare as a Program Manager responsible for the management & execution of process development activities in APAC region.

In his consulting role, has worked with several biopharma organizations on the

development of quality systems and audits.

Swapnil's area of expertise include

• Quality Systems

• CMC and Process capability

• Validations- Process, Cleaning, and

Equipment

• Operations and manufacturing process

• Personnel and training program