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Process Validation with Qualification Training Course
Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.
Details
Course overview
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
Who should attend?
This seminar will be of particular interest to all those from the pharmaceutical industry working in::
- Development
- Manufacturing
- Engineering
- Quality
It will also benefit the following personnel working in the pharmaceutical and biopharmaceutical industry:
- Process engineers
- Pharmacists
- Scientists
- Quality assurance professionals
- Quality control managers
- Late-stage product and process development engineers, scientists, pharmacists
- Technology scale-up and transfer managers
- Validation and qualification managers
- Validation and qualification specialists
- Risk management specialists
- Lean management specialists
- Operations managers and engineers
Programme
The science and risk-based approach to process validation
ICH Q8/9/10/11/12
Exercise 1 – Key points
Introduction to the FDA process validation guidance
Introduction to the EU Process Validation Guidelines and Annex 15
Exercise 2: Guidances
Process design: FDA PV Stage 1
Exercise 3 : Process Design
Quality risk management
Exercise 4: Equipment Qualification
Equipment and utility qualification: FDA PV Stage 2.1
Tools for Process Validation – part 1
Tools for Process Validation – part 2
Exercise 5: What techniques/ tools to use at which PV Stage
Process Performance Qualification / Process Validation – FDA PV Stage 2.2
Exercise 6: Process Validation - number of batches
Continued Process Verification / Ongoing Process Verification – FDA PV Stage 3
Exercise 7: Ongoing Process Verification
Case Study: Process improvement
Exercise 8: Continual Improvement
Exercise 9: SWOT
Presenter
Bruce Davis (More...)
Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Technology Transfer (TT), Quality Risk Management and other related topics. He has run many training events for companies both in the UK and internationally. He is past Chair of ISPE International Board of Directors. He led, co-lead or contributed to a number of their guidances for PV, QbD & TT and most recently has co-written one chapter on TT for ATMPs (i.e personalised medicines) . He is a professional engineer with many years’ experience in the pharmaceutical industry and a wide international knowledge. He previously worked at AstraZeneca, where his responsibilities included managing international engineering and leading changes to qualification practices. He is an established trainer and likes to engage with participants, to try to ensure the training experience is related to their particular requirements, and to bring in the importance of science and risk based thinking.
Book now
Book now
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14-15 Mar 2022 Live webinar |
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14-15 Mar 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 7 Feb 22* |
Enrol now
to attend Live webinar |
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20-21 Jun 2022 Face-to-face, (venue not yet confirmed) |
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20-21 Jun 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 16 May 22* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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26-27 Sep 2022 Live webinar |
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26-27 Sep 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 22 Aug 22* |
Enrol now
to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code