Data Integrity and Computer System Validation

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Dates Available

October 2-3, 2017


8:00 a.m. – 5:00 p.m.


CAD $795.00 + HST


AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Distinguished Faculty

Sean D. Benedik

SINCE 1998, Sean has been a leader in numerous areas of GMP pharmaceutical and medical device product manufacturing, testing, distribution, and validation for a wide range of companies across Canada, the United States, Mexico, and Europe. Leveraging his expertise as an analytical chemistry & quality systems professional, he has a proven track record as a solutions-based innovator that specializes in validation, quality assurance, quality control, design controls, and product development. Sean is a native speaker of the English and French languages with highly developed oratory skills. He is also well versed in adult learning techniques.

Day One – Course Topics and Agenda

8:00 AM – 8:30 AM Gathering and networking
8:30 AM – 9:30 AM 21 CFR Part 11: History and evolution
9:30 AM – 10:20 AM Electronic Records and Electronic Signatures
10:20 AM – 12:00 PM Regulatory Expectations for Data Integrity
12:00 PM – 13:00 PM Lunch
13:00 AM – 14:00 AM Demonstrating Data Integrity: Overview of Computer Systems Validation Deliverables
14:00 AM – 15:15 PM Procedural, User Requirements, and Functional Requirement Specifications
15:15 AM – 16:00 PM Computerized System Risk Assessment
16:00 PM – 17:00 PM Validation Protocols and Reports
17:00 PM End of Day 1

Day Two – Course Topics and Agenda

8:00 AM – 8:30 AM Gathering and networking
8:30 AM – 9:00 AM Questions and Clarifications from Day 1
9:00 AM – 10:45 AM Workshop: User Requirements, and Functional Requirement Specifications
10:45 AM – 12:00 PM Workshop: Computerized System Risk Assessment
12:00 PM – 13:00 PM Lunch
13:00 PM – 14:45 PM Workshop: Writing Validation Protocols and Reports
14:45 AM – 15:30 PM Change Control for Data Integrity Maintenance
15:30 AM – 16:00 PM Retirement and Decommissioning of Validated Computerized Systems
16:00 PM – 16:30 PM Data Archiving and Disaster Recovery Planning for Computerized Systems
16:30 PM End of Day 2 – Presentation of Completion Certificates

Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking

Note: Please indicate any special Dietary requirements when registering for the course

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.