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

Date Aug 23, 2018
Time 8:30 am to 6:00 pm
Cost 24000.00
Online
This new 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.
Majority of inspection reports such as 483’s and Warning Letters quote issues with 21 CFR Part 11 and data integrity as deviations from GxP regulations. Only way to control and avoid warning letters is by receiving effective Training. Our presenter’s extensive years of experience in the field of third party audit can help your team to better understand & could help reduce your vulnerability of getting 483’s and warning letters, by great amount.

OBJECTIVES:
  • Role of FDA
  • CSV Points
  • Why Validation? Its Benefits
  • GAMP 5
  • 21 CFR Part 11 Compliance
  • Annex 11
  • Data Integrity
  • Risk Assessment
  • Recent Learnings & Avoiding Warning Letters
  • CSV Deliverables
  • SOPs and Best Practices
  • CASE STUDIES ….and More
WHO SHOULD ATTEND:
A must attend seminar for professionals in Pharmaceuticals, QC Laboratories, Manufacturers of drug substances (APIs), Finished Products, Contract Laboratories, CROs, Medical Device & Biotech companies, and Suppliers of Computer Systems.

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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