The Validation Strategy Project is a 3-month scenario based innovative and practical component of the programme, which is designed to encourage the students to reflect on all modules and topics studied in Stage 1 of the programme in a holistic manner. This then provides the student with an opportunity to bring all the discrete elements of the programme together, and develop a high level Validation Strategy for a given Scenario
The Intended Use of the product
• The Primary Mode of Action (PMOA) of the product
• The regulatory pathway selected (i.e. the CGMPs and other regulatory
guidance that KS Pharmaceuticals needs to comply with).
• Indicate if there are any Human Factor studies in hand for the product that
may have implications on the commercialization and validation activities
• Outline the implications for the Quality Management System (QMS )on site –
i.e. enhancements / changes required
• The integrated risk management activities required over the validation
lifecycle
• The role of design controls, design verification and design validation within
your overall strategy
• Facility and Equipment Qualification approach
• Product and Process Validation strategies
• Cleaning Validation strategy
• Analytical Methods transfers / validations (where applicable)
• Stability testing (where applicable)
• The importance of Supplier qualification and Material qualification (note: if
these are activities undertaken at a corporate level indicate this in your strategy and indicate the timings) • Other specialist validation activities required which are technology specific.(e.g. injection molding, sterilization etc.) • A timeline or high level Gantt chart for the activities • Specialist Resource requirements (if applicable) • Potential Challenges to delivering a validated product with qualified equipment and facility • Potential Opportunities you
Validation Strategy Project
• The Intended Use of the product • The Primary Mode of Action (PMOA) of the product • The regulatory pathway selected (i.e. the CGMPs and other regulatory guidance that KS Pharmaceuticals needs to comply with). • Indicate if there are any Human Factor studies in hand for the product that may have implications on the commercialization and validation activities• Outline the implications for the Quality Management System (QMS )on site – i.e. enhancements / changes required • The integrated risk management activities required over the validation lifecycle • The role of design controls, design verification and design validation within your overall strategy • Facility and Equipment Qualification approach • Product and Process Validation strategies • Cleaning Validation strategy • Analytical Methods transfers / validations (where applicable)• Stability testing (where applicable) • The importance of Supplier qualification and Material qualification (note: if these are activities undertaken at a corporate level indicate this in your strategy and indicate the timings) • Other specialist validation activities required which are technology specific.(e.g. injection molding, sterilization etc.) • A timeline or high level Gantt chart for the activities • Specialist Resource requirements (if applicable) • Potential Challenges to delivering a validated product with qualified equipment and facility • Potential Opportunities
Research, Review of Course Material, Webinar, Discussion with Supervisor
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |