2-Day Computer Systems Validation Course with Data Integrity
Upcoming

  • Day 1March 6, 2019
    9:00 am - 4:30 pm
  • Day 2March 7, 2019
    9:00 am - 4:30 pm

Location

15 Allstate Parkway, Suite 600, Markham, Ontario, Canada, L3R 5B4
M QA QC

Certification Areas

Are you new to Computer System Validation (CSV)? Or are you currently working in a GxP environment and subject to meeting the regulatory requirements for computerized systems? Do you support CSV efforts either directly or indirectly?  If you do, this workshop can provide the basics for understanding the regulations, trends and methodology used to successfully perform CSV. Day One provides an overview of the regulations and principles of CSV. Day Two focuses on breaking down the specific phases and deliverables needed to successfully validate computerized systems.

 

DAY 1 – CSV OVERVIEW

·         Need for Computer Validation

·         Regulations

·         CSV Principles

·         Standards and References

·         Risk Assessment

·         Data Integrity for CSV

 

DAY 2 – VALIDATION BREAKDOWN

·         Systems Inventory

·         Validation Planning

·         Vendor Audit

·         System Specifications

·         Test Methodologies

·         IQ/OQ/PQ

·         Maintaining the Validated State

·         Network Qualification

·         Retrospective Validation

·         SOP & Training

 

ADDITIONAL ITEMS (Supplemental Sections)

·         Issue Resolution & Trace Matrix

·         Change Control & Configuration Management

·         Disaster Recovery

 

 

WHO SHOULD ATTEND:

This two day workshop is designed for both non-IT and IT professionals working in the regulated life science industries. These include, but are not limited to professionals in Quality Assurance, Quality Control, Regulatory Affairs, Data Center Operations, System Sponsors, Validation Teams, Software Suppliers, CROs, Contract Data Services, and other Contract Suppliers of computerized services subject to GCP, GLP, GMP (GXP) regulations.

 

SPEAKER:

David McSweeney BSc, AIT is a subject matter expert for Computer System Validation. He has been working in the Pharmaceutical industry for 24 years from Research, Production, Information Technology, Project Management. He has lead projects for multinational pharmaceutical manufacturers including Sanofi Pasteur, GSK Biologicals, Teva, Apotex, Therapure BioPharma, Boehringer Ingelheim, MDS Pharma Services / Clearstone Labs in the United States, Canada and Internationally. David is an expert in Project Management and GxP, specializing in IT Projects, Quality Management, Data Integrity and 21 CFR Part 11 compliant computerized systems. He has successfully worked on a variety of Computer Systems Implementation projects in manufacturing and research laboratories validating infrastructure, standalone computerized lab instruments and complex global networked systems.



Student Ticket: $250.00 On Sale
Basic Member Ticket: $995.00 On Sale
Group Tickets (5+): $875.00 On Sale
Pro/Pro Plus Member Ticket: $925.00 On Sale