Computer System Validation (CSV), Data Integrity and 21 CFR Part 11 Compliance

Date Dec 20, 2018
Time (8.30 AM – 5.30 PM)
Cost Rs. 24,000
Online
This latest 2-day Seminar on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance.

Why You Should Attend:
This workshop provides the regulatory background and guides attendees through the complete record lifecycle from data evaluation, reporting, archiving and retrieval. It also helps to fully understand not only the text but also the meaning of related regulations such as FDA’s Part 11 and the Annex 11.

Who Should Attend
A must attend seminar for professionals in Pharmaceuticals, QC Laboratories, Manufacturers of drug substances (APIs), Oral Solid Dosage Form, Contract Laboratories, Clinical research Organizations, Contract Research Organisations, Contract Manufacturing Organisations and Biopharma companies.

DEPARTMENTS:
  • Quality Control & Quality Assurance
  • Research and Development
  • Laboratory
  • Regulatory Compliance
  • IT/IS & Software Departments
  • Validation
  • Production & Manufacturing
  • Documentation
  • Training Departments

PROFESSIONALS:
  • Managers and Supervisors
  • Senior Managers and Team Leaders
  • Directors, VP’s, CxO’s, General Managers
  • Analytical Chemists
  • Validation Specialists
  • Laboratory Managers and Supervisors
  • Regulatory Affairs Managers
  • Documentation Specialists & Analysts
  • Consultants and Systems Administrators

 


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