DUBLIN, Dec. 15, 2017 /PRNewswire/ --
The "Process Validation with Qualification" conference has been added to Research and Markets' offering.
Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment
The two-day process validation in the US and EU, balancing science and risk during the product lifecycle meeting will help you gain an understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, under the link between Quality by Design and process validation as well as how to apply relevant tools for process validation including risk assessment.
Benefits in attending:
- Know the scope of the FDA and EU validation guidelines
- Establish a 3 stage, science-and-risk-based, lifecycle process validation programme
- Clarify similarities and differences between EU and US expectations, with consideration of differing company requirements eg innovative to generic manufacturers
- Understand how Quality by Design supports process validation
- Link product requirements, to equipment verification to commercial scale process validation
- Gain knowledge in qualification including Good Engineering Practice (GEP)
- Apply tools such as Quality Risk Management, Design of Experiments and Statistics
- Unscramble the real meaning of buzz words' such as qualification, verification, commissioning, calidation etc.
- Realise significant business benefits from taking a science and risk-based approach
Who Should Attend:
This seminar will be of particular interest to all those from the Pharmaceutical Industry working in:
- Development
- Manufacturing
- Engineering
- Quality
Personnel from the pharmaceutical and biopharmaceutical industry with the following background:
- 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
Agenda:
Programme Day One
09.00 Registration and coffee
09.30 Welcome and Introduction
10.00 The Science and Risk-Based Approach to Process Validation
10.30 ICH Q8/9/10/11
11.20 Introduction to the FDA Process Validation Guidance
11.50 Introduction to the EU Process Validation Guideline and Draft Annex 15
12.20 Discussion
12.30 Lunch
13.30 Exercise 1: Guidelines
13.50 Process Design: FDA Stage 1/EU Pharmaceutical Development
14.20 Exercise 2: Process Design
14.50 Equipment & Utility Qualification: FDA Stage 2.1/EU Annex 15
15.20 Refreshments
15.35 Exercise 3: Equipment Qualification
16.10 Feedback and Discussion
16.25 Process Performance Qualification/Process Validation: FDA Stage 2.2/EU approaches
17.00 End of Day One
Programme Day Two
09.00 Introduction to Day Two
09.15 Quality Risk Management
09.45 Exercise 4: Process Validation
10.45 Refreshments
11.05 Continued Process Validation/Ongoing Process Verification: FDA Stage 3/EU Annex 15
11.35 Exercise 5: Ongoing Process Verification
12.05 Continual Improvement and Process Optimisation
12.30 Lunch
13.30 Exercise 6: Continual Improvement
14.30 Feedback and Discussion
15.00 Case Study: Process Improvement
15.30 Refreshments
15.45 Discussion: Implementation Challenges
16.00 Case Study: Continued/Ongoing Process Verification
16.30 Feedback and Discussion
16.45 End of Seminar
For more information about this conference visit https://www.researchandmarkets.com/research/hcvlxq/two_day_course?w=5
Media Contact:
Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
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