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START2PHARMA: VALIDATION FUNDAMENTALS: EQUIPMENT & SYSTEM QUALIFICATION

This course is designed to explain why regulatory agencies require Validation, as well as the consequences of failing to validate processes & systems. Attendees will gain a broad general background in validation and in addition also the practical application of equipment and system qualification. The course will provide a walk through the different general steps in validation, the concrete steps for qualifying equipment/ systems, the qualification methods and the “key deliverables”. After the training the trainees can apply a basic structure for the necessary qualification documents (protocols/report) and document in a correct way.

REGULATIONS CONSIDERED

FDA 21 CRF, FDA guidance on process validation, EU V4 Annex15, EU V4 Chapter 4: Documentation

ADDED VALUE

Practical training given by experts with experience in various domains. The participants will gain sufficient background and tools to work with. A come back session is planned to discuss the trainee experiences in the field.

LEARNING OBJECTIVES 

At the end of the course participants will be able to

  • Understand the concepts of Validation
  • Understand why validation is important to the product quality & regulations
  • Understand the whole validation approach from VMP to different types of validation
  • Apply the different steps in V-cycle for equipment/system qualification
  • Understand the main roles in a validation project
  • Understand hot topics like QRM, ASTM & QBD
  • Practice basic change analyses & write rationales
  • Practise basic user requirements analyses
  • Practise good documentation in validation
  • Practise basic validation tasks
  • Know what is expected from them on a first junior validation mission

SCOPE

Basic validation course containing general concepts + specifics on equipment/system qualification Pharma & life science

Speakers

Niek De Schouwer

Programme

  1. What and why validation
  2. Types of validation
  3. Short Introduction to process validation
  4. Quality by Design
  5. Extended introduction in qualifying for equipment/systems:
    • Steps in the Validation Life Cycle: V-Model/ASTM
    • Validation plan and URS
    • Quality Risk Management
    • Project management for qualification:
    -Approach
    -Several steps and high level timelines/milestones
    -Stakeholder management
    -Roles and responsibilities (RACI)
    -Work with suppliers
    • Protocols/reports/procedures
    -Templates & structure in the different documents
    -Good Documentation Practices
    • Change Control, Quality review and VMP (validation master plan)
    • Roles and responsibilities

Event Details

Date:

Thursday, April 4, 2019 (08:30 h - 17:00 h)

Location:

Antwerp, Blue Point, Filip Williotstraat 9

Price:

Price per day: 750 €/excl. VAT

30 % discount for early birds (subscription before 30th of March 2019)
Until 50% discount through KMO portfolio or training vouchers (DV.O218731)
Full reimbursement through Co-valent : https://www.co-valent.be/
50% discount for students and PHD’s

Language:

Dutch

Organiser(s):

2019-04-04 08:30:00 2019-04-04 17:00:00 Europe/Brussels START2PHARMA: VALIDATION FUNDAMENTALS: EQUIPMENT & SYSTEM QUALIFICATION Antwerp, Blue Point, Filip Williotstraat 9 <p><a href="/www.qpeople.be" target="_blank">QPeople</a></p>

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