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2 Day In-Person Seminar on Computer Systems Validations, Data Integrity, 21 CFR Part 11 Compliance and GAMP 5

This new 2-day Seminar on Computer Systems Validation provides participants with knowledge and tools to effectively use, monitor, control, and assure the integrity of electronic data and computerized systems. The presenter - Mr. KR Vaghela will help you explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. The course not only ensures a full understanding of the regulations and guidelines for raw data and other records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations.
Areas Covered:
Role of FDA
Computer Systems Validation Points
Why Validation?
Benefits of Validation
Understanding GAMP 5
21 CFR Part 11 Compliance
Annex 11
Data Integrity & Security
Where & How to know the occurrence of data integrity failures
Validation Master Plan (VMP)
Related Warning Letter Points
Computer Systems Validation Deliverables
Risk Assessment .and More
Training Methodology:
Chalk and Talk
Group Discussion
Interactive Q&A Sessions
Case Studies
Who Will Benefit:
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.
The teams that will benefit the most are:
Quality Control & Quality Assurance
Laboratory Departments
Research & Development
IT/IS Departments
Software Development
Regulatory Affairs
Training Departments
Documentation Departments
Professionals who will benefit include:
Managers and Supervisors
Senior Managers and Team Leaders
Directors, VPs, CxOs, General Managers
Analytical Chemists
Validation Specialists
Laboratory Managers and Supervisors
Regulatory Affairs Managers
Documentation Specialists
Consultants, Analysts, Training Specialists and Computerized Systems Administrators

1. Hyderabad, India | Date: April 18th and 19th, 2017 | Time: 9 AM to 6 PM
2. Mumbai, India | Date: April 24th and 25th, 2017 | Time: 9 AM to 6 PM
Register Now, to avail up to 35% Early Bird Discounts (Ending March 9) !
Registration Details:
Registration Link

Contact Information

  • Name: Compliance Trainings

    Company: Compliance Trainings

    Telphone: 080-4170-0521 , -

    Address: Compliance Trainings
    861, Peripheral Ring Road, Koramangala, Bangalore 560095, Karnataka, India
    Phone: +91-080-4170-0521
    Website :