Computerized systems validation GAMP5 approach (2 days)

Courses objectives

• Understand and assimilate the validation guidelines applied to computerized and automated systems according to the validation methodology GAMP5 and new Data Integrity requirements
• Assimilate and apply GAMP5 concepts, ASTM E2500 approach and new Data Integrity main concepts
• Assimilate and apply the 21CFR part 11 and new Annex 11 “risk analysis” approach.
• Assimilate a “modular” approach to Validation in order to be able to define the activities and effort required to validate each automated and computerized system
• Assimilate the writing of the protocols and test sheets

Training methods

• Based on GAMP5 methodology and Data Integrity guidances
• Case studies
• Working groups
• Presentation

Audience

Everyone involved in the computerized and automated systems validation process (ERP, GPAO, LIMS,SCSE, WMS, SCC, MES, automats…) : IT and automated (technical and functional) project managers, users project managers, validation managers, representative of the quality assurance department.

Dates and costs 2022

April 12th and 13th 2022  /  October 4th and 5th 2022 — PARIS
April 26th and 27th 2022  / October 18th and 19th 2022 — LYON
Cost : 1150€ excl. VAT, breaks and lunch included

DETAILED PROGRAM

FIRST DAY

Presentation of applicable French, European and American regulatory requirements and reference guides : BPx, GxP’s, cGMP’s, Part 11, Part 58, Part 820, Guidances Data Integrity (MHRA, FDA, PIC’s),  PIC’s Guide, ASTM E2500

Présentation des évolutions 21 CFR Part 11, Annexe 11 des BPF et Data Integrity

• Key points and application
• “Risk Analysis” approach
• Presentation of the key points of the GAMP5 methodology

The validation process

• Planning: Validation Plan, Risk Analysis, Supplier Audits
• > Focus on the Risk Analysis process
• Specifications  : URS, FS, HDS, SDS
• Verifications : Design reviews, Traceability Matrix, Supplier tests, Installation, Functional, Performance…
• maintenance of validated state : periodic reviews, operating procedures, change control and backup / restore …

Capitalization approach: methodology, rules and practices allowing the capitalization of supplier activities (specifications, tests) and guaranteeing good coverage, good execution and good traceability of Tests

SECOND DAY : Concrete exercises and examples

Implementation of an optimized validation strategy based on the GAMP 5 risk analysis approach, the concepts of ASTM E2500 and guidance on Data Integrity GxP.

Design of the Validation strategy: rational methodology based on risk analysis and allowing to systematize a modular and optimized approach (“just necessary”) for the different IS validation cases.

Conduct of risk analysis: approach, example of risk analysis of typical systems : ERP/GPAO, automation, Labo

Design of key validation documents: presentation and design of an example of: Design review, Installation, Operational and Performance Test Protocols.

Pharmasys is an approved organization (activity declaration number: 11 91 0806691) and listed in Datadock. It is therefore quite possible to go through your OPCA for the financing of the latter. You will find all the information you need to create your request for assistance in the training contract that will be sent to you.

We are at your disposal for any request for additional information.