These latest 2-day Seminars 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.
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.
Our instructors will use examples and real life case studies to better illustrate the application of the techniques for any validation project. With effective implementation of learnings from this seminar, you can avoid warning letters, reduce costs, improve quality, increase compliance with less documentation. Interactive exercises will be dispersed into and between the presentations.
Learning Objectives :
Understanding Validation
21 CFR Part 11
GAMP5
Computer System Validation
Qualification vs Validation
Effective SOPs, Verification and Testing
Data Integrity
ALCOA
Good Data Management Practices
CASE STUDIES will also be presented
Will benefit Professionals from :
Quality Control | Quality Assurance | Research and Development | Laboratory |
Regulatory Compliance | IT/IS & Software Departments | Validation | Production & Manufacturing | Documentation | Training Departments
For Sponsorship & Registration please contact:
Neil, Manager -Business Development
nilotpal.p@compliancetrainings.in I 8867363146
