Professional Training
4.3 (18 Reviews)

Process Validation with Qualification

International Professional & Industry Academy, In London (+1 locations)
Length
2 days
Price
1,299 - 1,499 GBP 1,299 GBP
Next course start
21 May, 2024 (+2 start dates)
Course delivery
Classroom, Virtual Classroom
Length
2 days
Price
1,299 - 1,499 GBP 1,299 GBP
Next course start
21 May, 2024 (+2 start dates)
Course delivery
Classroom, Virtual Classroom
Leave your details so the provider can get in touch

Process Validation with Qualification

Attending this invaluable two-day event will give you the tools to fully understand and comply with current EU and FDA process validation guidelines and meet implementation challenges.

Taking a practical and analytical approach to process design, equipment and utility qualification, the programme will link product requirements to equipment verification and commercial-scale process validation.

Good engineering practice (GEP) and a range of techniques, including quality risk management and design of experiments
and statistics, will be examined to optimise continual improvement in process qualification, verification, commissioning and validation.

Benefits of attending:

  • Know the scope of FDA, EU and other international validation guidelines
  • Establish a three-stage, science and risk-based, life cycle process validation programme that can be applied to all products internationally, from generic products to novel medicines to ATMPs
  • Clarify similarities and differences between EU and US regulatory expectations
  • Understand the importance of a science and risk-based approach to support process validation and qualification
  • Realise significant business benefits by clarifying the key purposes of validation
  • Reduce validation documentation by concentrating on product drivers supported by clear qualification steps
  • Unscramble the real meaning of buzzwords such as qualification, verification and validation
  • Learn tools and techniques for you to subsequently apply to your products

Upcoming start dates

Choose between 2 start dates

21 May, 2024

  • Virtual Classroom
  • Online
  • English

23 September, 2024

  • Classroom
  • London
  • English

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Reviews by course attendees

Average rating 4.3

Based on 18 reviews.
Reviews are published according to our review policy.
Write a review!
5/5
Rebecca I
26 Sep 2022

Very pleased with the course, it was thorough and there was plenty of time for discussion and questions. Coming from a medical device background there was a lot of cross over...

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3/5
John C
26 Sep 2022

Engaging and knowledgeable speaker.

4/5
Jason S
26 Sep 2022

This course was extremely valuable for those initially dealing with Process validation and those who may have been performing validation and needed a broader understanding. The ...

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