ComplianceOnline, Online Event
2011-04-28
This webinar on software validation will review the validation activities required as the next step in the development of a Validation Plan as part of the Total Quality Commitment critical in all regulated industries. Why Should You Attend: A Validation Plan is the backbone of a company's validation activities and provides a clear and concise plan for complying with 21 CFR Part 11. The categorization of software determines the validation activities to be followed. In this webinar, we will discuss the five categories of software and also focus on the activities required for validation. Examples of each category and activities will be discussed and frequently asked questions will be answered (e.g. Do I have to validate an Excel Spreadsheet?) The components of the Validation Plan will be identified and activities describing timing and roles/responsibilities required for the specific system will be also be discussed. Areas Covered in the Seminar: This seminar will review the activities driven by the Validation Plan: - Software categorization
- Validation activities based on the development life cycle (specification, design, construction/build, testing, installation, acceptance testing)
- Validation roles and responsibilities
- A summary of the equipment, systems or processes that will be validated
- Reporting - the types and format of the documentation that will be used
Who Will Benefit: This webinar will provide valuable assistance to all regulated companies including: - Information Technology Managers & Professionals
- Quality Assurance Staff
- Quality Control Staff
- GMP, GCP, and GLP Professionals
- Regulatory Affair Managers & Staff
- Clinical Data Management Professionals
NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.
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