Faculty: Saurabh Joshi ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3514


  • Date: 3/1/2024 10:00 AM - 3/1/2024 11:00 AM
  • Time zone: Eastern Time (US/Canada) Online Event

 

Description

Risk assessment is not a new topic; however, it is still very much misunderstood. People from the industry often get confused between which guidance should be followed-WHO, ANSI, Britsafe or ICH. In this webinar we will go through the basics of ICH Q9 as it is the one which is mostly applied in Pharma/Lifesciences industry. We will see how various tools can help you achieve your risk assessment goals. We will also touch how digital risk assessments can enhance your risk assessment process and make you confident for a regulatory inspection.

Areas Covered In The Session:

  • Risk assessment and its stages
  • Why is risk assessment indispensable?
  • Some significant tools
  • Areas if Risk tool application
  • Digital risk assessment
  • What is CSA
  • How different is it from CSV
  • Elements of CSA
  • How you can transition from CSV to CSA                                         

Who Should Attend:

  • Quality Departments
  • IT Departments
  • Stakeholders responsible for Risk Assessment
  • 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.