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
Research, Review of Course Material, Webinar, Discussion with Supervisor
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |