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Mr. Vikram Kulshreshta

Director, API & Formulation

Mr. Vikram Kulshreshta is a Senior Management Professional with experience of more than 30 years with strong Quality Assurance & Regulatory Affairs background, with a good track record in the Organizations worked for. He is an expert in “Designing & implementing the Quality Systems”, Qualifications & Validations, Trouble-shooting & CAPA implementation and Regulatory Affairs.

He is well versed with International cGMP regulations, e.g. USFDA, MHRA, TGA, ANVISA, MCC, COFFPRIS Mexico. He has conductrd Interactive workshops on QMS elements, with real life examples through interactive approach & Case studies, so as to enhance learning benchmarks for the participants. Has Registered many Drug Substances & Drug Product dossiers to US, Europe and other regions. Expert in handling Post DMF Approval changes. Consultant for - API & Formulation manufacturing companies for USFDA/EU Audit preparations, Helped the companies to get USFDA, EU & other Regulatory approvals. Conducts Pre-inspections Gap analysis & compliance.



  •  Tuesday, November 20, 2018
  • 11:00 AM CEST,
  • 60 Minutes
  • ¤115.00
OOS & RCA - A Strategy Beyond the Barriers

The webinar covers the practical approach for Root causes analysis, using different tools which can be used for Root cause analysis, tracking/trending of Root cause as a tool for improvement & designing strong CAPA.

  •  Wednesday, January 16, 2019
  • 08:00 AM PST | 11:00 AM EST,
  • 60 Minutes
  • ¤110.00
OOS Investigation & Root Cause Analysis

In a Healthcare facility, Manufacturing Processes & analysis methods are validated, personnel are qualified

  •  Thursday, February 21, 2019
  • 08:00 AM PST | 11:00 AM EST,
  • 60 Minutes
  • ¤110.00
Why & How do we Fail an FDA Inspection

Trend of inspections is changing globally. While earlier the inspections were focussed on evaluating the procedures in line with the established International standards, but now the focus is on an Investigative approach.





  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤155.00
OOS & RCA - A Strategy Beyond the Barriers

The webinar covers the practical approach for Root causes analysis, using different tools which can be used for Root cause analysis, tracking/trending of Root cause as a tool for improvement & designing strong CAPA.

  • Recorded
  • View Anytime
  • ¤150.00
OOS Investigation & Root Cause Analysis

In a Healthcare facility, Manufacturing Processes & analysis methods are validated, personnel are qualified

  • Recorded
  • View Anytime
  • 60 Minutes
  • ¤150.00
Why & How do we Fail an FDA Inspection

Trend of inspections is changing globally. While earlier the inspections were focussed on evaluating the procedures in line with the established International standards, but now the focus is on an Investigative approach.