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Computer System Validation Fundamentals Course

April 11, 2014
09:00 AM to 04:00 PM EST

Instructor:   Victor Zurita, CEO of Compliance Associates
Date: April 11, 2014
Time: 9am-4pm
Location: 8000 Jane Street, Concord ON L4K 5B8
Duration: 1 day
Cost: $800 per student
Group Pricing:  Enroll two students at full price and receive a third seat FREE.

Course Description:
For many professionals, achieving the delicate balance between satisfying compliance requirements and the time it takes to do so could mean the difference between passing an audit and losing revenue dollars.

Understanding the principals behind every validation effort and achieving proper documentation that shows your system performs as the requirements specify will be the first step in answering the question of how much to validate.

To help solve these challenges Compliance Associates is offering a Computer Systems Validation Fundamentals course.  During this training we will teach basic validation principals that will help companies establish a solid foundation for delivering technology solutions in FDA and Health Canada regulated environments.    

Compliance Associates Computer System Validation Experience:

Victor has more than 27 years of experience in the life sciences industry. He specializes in laboratory and manufacturing equipment qualification as well as computer systems that support the regulated enterprise.  These systems include LIMS, ERPs, MES, Data Networks, Data Collection Systems, and Electronic Content Management.

What You Get:
o    Introduction to the key FDA & international regulations and guidance
o    Understanding of the key FDA and international regulations and guidance regarding CSV and which apply to your company
o    An overview of the computer system validation framework and deliverables
o    Validation testing: IQ, OQ, PQ documents, such as 21 CFR Part 11
o    Best practices for validation test execution, documentation, and error handling
o    Certificate of completion

Who Should Attend?  
o    System owners, IT managers and directors new to the FDA regulated environment
o    Quality assurance professionals new to software quality
o    Computer system project managers and team members who need to understand the validation process

Materials Provided: 
o    Student reference materials (slide handouts)
o    Certificate of completion
o    Continental breakfast, lunch and afternoon snack

Detailed Course Description:

1.  Computer Validation Fundamentals
o    Who needs to validate?
o    What is Computer Validation?
     o    Core principles
     o    Brief history of computer validation
o    Review of the computer validation references in regulations and guidance:
     o    21 CFR Part 211
     o    21 CFR Part 11
     o    Annex 11: Computerized Systems

2. Computer Validation Process and Deliverables
o    What is the SDLC (System Development Life Cycle) process?
o    How does computer validation fit into the SDLC?
o    What content must be covered?
o    What are the expected tasks and deliverables?
o    System/software specifications
o    How 21 CFR Part 11 applies to computer validation
o    Risk Assessment in computer validation
     o    Where does it apply?
     o    A walkthrough of the GAMP risk assessment process
o    Validation Plans and Master Validation Plans
o    Installation Qualification (IQ)
o    Operational Qualification (OQ) and Performance Qualification (PQ)
o    SOPs required for system operation and maintenance
     o    How they related to FDA Warning Letters
o    Validation Summary Reports

3. Specific Topics
o    Overview of 21 CFR Part 11 (Part 11)
o    GAMP-Specific Computer Validation Topics
o    Auditing Computer System


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