Dublin, May 30, 2024 (GLOBE NEWSWIRE) -- The "Process Validation with Qualification Training Course" conference has been added to ResearchAndMarkets.com's offering.
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: Guidance
- 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
For more information about this conference visit https://www.researchandmarkets.com/r/sqa8md
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