Computerised System Validation (ANVISA Guide 33)

Request a quoteSpeak to our team

01

Course description

A specialist course in Computerised System Validation (CSV) applied to the life cycle of systems used in regulated environments, based on ANVISA Guide 33, GAMP 5 principles, 21 CFR Part 11 (FDA) and data integrity requirements applicable to medical device manufacturers.

02

Course objective

Equip participants to plan, conduct and document the validation of computerised systems critical to product quality and safety, ensuring regulatory compliance, traceability and data integrity throughout the system life cycle.

03

Course programme

32h of in-depth learning
  1. 01

    Scope and application of ANVISA Guide 33

  2. 02

    The validation life cycle (V-Model) and a risk-based approach

  3. 03

    Validation Master Plan (VMP) and Validation Plan (VP)

  4. 04

    Specifications: URS, FS, DS and the traceability matrix

  5. 05

    IQ, OQ and PQ qualifications and acceptance testing

  6. 06

    Data integrity (ALCOA+) and electronic signatures

  7. 07

    Change control, failure management and revalidation

04

Who can attend?

  • Regulated IT, Quality Assurance, Validation and Regulatory Affairs professionals, Auditors and Technical Managers working in medical device companies, laboratories and ANVISA-regulated industries.