GAMP 5 Practitioner (2 days) - April 20th and 21st 2020, The Netherlands

GAMP 5 Practitioner (2 days) - April 20th and 21st 2020, The Netherlands

Two-day GAMP 5 Training

Rescop Academy is providing the training ‘GAMP 5’ practitioner level on April 20th & 21st,2020 in The Nederlands.

Following a practical case of developing a hospital transportation device, our experienced trainers will let you experience the basics and potential pitfalls of Validation following the Good Automated Manufacturing Practices (GAMP 5) Guideline.

Course Content:

Introduction of the case and setting a benchmark for the course by having trainees define the business processes, execute system risk assessment and create requirements using their current knowledge.

Practical exercise of the GAMP 5 activities:

  • Writing clear user requirements
  • Executing FMEA Risk Analyse
  • Translating User Requirements into a decent design
  • Describing the configuration and Building instructions in an unambigious way
  • Defining and executing Test Protocols and Scripts
  • Executing Change while maintaining compliance

Program:

Summary Day 1
Case: Processes & System Risks
Case: High Level Requirements Terms & Definitions Regulations, Guidelines & Standards Requirements Specification
Case: SMART Requirements, Risk Assessment
Case: Functional Risk Assessment, GAMP 5 Guideline
Case: Design, Installation & Instructions

Summary Day 2
Case: Build, Waterfall vs Agile, Qualification Phase
Case: Test Protocols, Test Execution
Case: Verification, Release to Production, Procedural Controls
Case: Operations

Dates & Location

April 20th & 21st 2020
Leiden
The Netherlands

Investment

Young Professional: € 995,-

Early Registration (up to 4 weeks prior to event): € 1125,-

Regular Fee: € 1250,-


Prices listed are excl. VAT

 


Register now