AGENDA
10:00 AM EST
Webinar Host Opening Remarks
Howard Wilesnky, Executive Director, KENX
10:15 AM - 11:45 AM EST
A Holistic Approach to Implementing Successful Science and Risk-Based Process Validation
Javier Cardenas, PhD, Senior Consultant, Azzur Group
11:45 AM - 12:00 PM EST
Break
12:00 PM EST - 1:30 PM EST
Process Validation Lifecycle – A Stage 1 and Stage 2 Implementation Case Study
Nyasha Madziva, Validation Lead, Azzur Group
1:30 PM EST - 1:45 PM EST
Break
1:45 PM EST - 3:15 PM EST
Continued Process Verification (CPV) and Continuous Monitoring– Maintain the Validation State
Connie Hetzler, Global Head – Validation, Alcon Laboratories
3:15 PM EST - 3:30 PM EST
Break
3:30 PM EST - 5:00 PM EST
Hot Topics in Process Validation – Process Optimization, Interdisciplinary Teams, and Software
Joscelyn Bowersock, MS-RA, Customer Success Manager, L7 Informatics
Develop, Implement and Maintain a Risk-based Program Enterprise-wide
FDA’s 3-Stage life cycle approach is the backbone of all validation and is globally recognized as the gold standard. Although the concept was introduced in 2011, industry still struggles with the complex challenges of our rapidly change quality and technical environments. KENX is proud to present this virtual training that help you master a risk-based life cycle approach, good documentation practices, Continued Process Verification and much more that will have an immediate impact on your organization.
Top Reasons to Attend
- Address process validation expectations from industry guidance
- Identify the QbD principles critical for a successful Stage 1
- Understand the importance of a robust process control strategy
- Implement risk-based approaches for system/process monitoring
- Design in flexibility to policies and procedures
- Define the manufacturing process flow and quality targets
- Build methodology to classify attributes and parameters
- Data organization strategies – Account for multiple batch and packaging sizes – Bracketing/matrix/family grouping
- Use JMP® 15 for Statistical Process Control charts
- Calculate and interpret process capability indices
- Account for non-conformances and deviations
- Continued Process Verification (CPV) and Continuous Monitoring– Maintain the Validation State
- Discover the similarities of pharmaceuticals and medical device industries – What we can learn from each
- Understand the importance of using statistics
- Maintain a state of control over the product lifecycle
- Receive tools that enable effective and efficient validation
- Develop an Interdisciplinary team
- Maintain the validation state through effective Continuous Process Verification (CPV)
- Receive example templates for plans and reports
- Understand and implement documentation best practice
Personnel in the Following Environments Should Attend:
- QA/QC
- Validation
- Document Management
- Commissioning and Qualification
- Engineering
- Regulatory Affairs
- Manufacturing
- Laboratory
This event is also appropriate to business development and sales managers that offer innovative solutions for quality validation and engineering professionals in the life science industry.
Presenting Sponsor:
