Guidance for Computer software assurance is currently being discussed in the industry after FDA released its draft guidance “Computer software assurance for production and quality system software” in Sept 2022. While everyone wants to implement it in some or the other form, there’s no clarity in the domain on how it should be transitioned from CSV to CSA. In this webinar we’ll try understanding how it can be done with ease and compliance.
Areas Covered in the Session :
- What is CSA
- How different is it from CSV
- Elements of CSA
- How you can transition from CSV to CSA
Who Should Attend:
- Stakeholders responsible for CSV
- Stakeholders tasked with shift from CSV to CSA
- Quality personnel/IT teams
- Digital leadership
Course Director: SAURABH JOSHI
Saurabh is an industry professional with >20 years of experience in working in the areas of Quality operation, Quality systems, Tech. transfer Quality, Compliance, Validation and Qualifications. He has worked with reputed companies like Cipla, Microlabs, Wockhardt India and EU, Torrent, Sun Pharma and Alembic. He has led regulatory inspections like USFDA, MHRA, WHO GMP (Geneva), HPRA etc and has executed robotics and automation projects for industry 4.0 transformation.
From shopfloor at site to leading corporate level function and consulting world’s oldest pharmaceutical company- Merck specialties Pvt. Ltd. (A Merck KGaA, Darmstadt Germany company), Saurabh has delivered value in his assignments.
He’s currently working with ValGenesis as Director-Solution Engineering. In his role he’s responsible for expanding customer outreach and demonstrate platform capabilities with ValGenesis’s solutions to lifescience companies.