Systems GxP, data integrity, quality, validation

Data Integrity awareness and validation of Computerized Systems (2 to 4 hours)

 

Objectives of internship

  • Understand the validation of computerized systems
  • Understand the need (regulatory requirements) and the usefulness (Good Practices) of IS validation
  • Understand the different validation activities and their operational implications
  • Understand the respective roles of users, Quality Assurance, CIO and suppliers
  • Know the benefits and risks of validation

Teaching methods

  • Intra-company seminar
  • Presentation and delivery of a summary document
  • Duration: 2 to 4 hours

Staff concerned

Heads of Services, Operational Directors, Head of Technical Services, Quality Assurance Directors of the pharmaceutical, medical devices, pharmaceutical and cosmetic chemistry sectors

Dates and costs 2022

Date: Contact us

Cost: Consult us

DETAILED PROGRAM

1 — PRESENTATION OF EUROPEAN AND AMERICAN REGULATIONS

  • Requirements: regulations, organizations and guides relating to computerized systems
  • New Part 11 flexibility: key points and practical consequences

2 — PRESENTATION OF VALIDATION

  • Principle
  • Methodology: activities and Good Practices
  • Implications of different actors and different organizations of the company

3 — RETURNS OF EXPERIENCES

  • Benefits of validation
  • Risks of non-compliance: examples of FDA Warning letters

4 — QUESTIONS/ANSWERS

 

Pre-registration :

9 + 7 =

 

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.

Carreers

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Contact

PHARMASYS GROUP
36, Place Nelson Mandela
91300 MASSY
Tel : +33 (0)1 69 35 05 43
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