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
Certification:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
DAY 1
- 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: Risk assessment
DAY 2
- Equipment and utility qualification: FDA PV Stage 2.1
- Exercise 5: Equipment Qualification
- Tools for Process Validation - part 1
- Tools for Process Validation - part 2
- Exercise 6: What techniques/ tools to use at which PV Stage
- Process Performance Qualification / Process Validation - FDA PV Stage 2.2
- Exercise 7: Process Validation - number of batches
- Continued Process Verification / Ongoing Process Verification - FDA PV Stage 3
- Exercise 8: Ongoing Process Verification
- Case Study: Process improvement
- Exercise 9: Continual Improvement
- Exercise 10: SWOT
Speakers
Mr Bruce Davis,
Associate ,
NSF HealthsciencesBruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Quality Risk Management, GMP for Engineers and other related topics. He has run many training events for companies both in the UK and internationally and is often invited to speak at international conferences.
He is past Chair of ISPE International Board of Directors and led their case study for practical implementation of QbD. He co-chaired the team updating their Technology Transfer (TT) Guide and carries out training for them and other organisations.
He is a professional engineer and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and understanding of current regulatory approaches in the above topics for both US and EU.
He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, facilitating QbD and leading changes to qualification practices.
He played a leadership role to set up De Montfort University’s MSc distance learning course in QbD.
He is an Associate to NSF Healthsciences, and for them has carried out consultancy and training in the above topic areas, and also for driving down human error.
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
