Speaker Hedley Rees
Available as an in-house course
Overview
Rapidly changing regulatory frameworks, business models and global structures have dramatically impacted the landscape for practitioners in pharmaceutical quality and regulatory compliance. The traditional vertically integrated model has been replaced by a hybrid mix of third party contractors, sponsor companies and licensing partners. The chain of custody has become increasingly complex to plot, making it ever more difficult for QP’s and RP’s to fulfil their custodial responsibilities within the supply chain.
Course Details
This 1 day workshop looks at how supply chains evolve through the development process, from pre-clinical, right the way through to global launch. Risk assessment methodologies are explored to help identify critical risk areas and develop mitigation strategies in collaboration with key stakeholders. In effect, adopting processes to build in visibility, traceability and compliance so that risk and opportunity for error are reduced to an absolute minimum.
The format of the workshop will be interactive, using case study exercises. Participants will be encouraged to bring along any burning issues current within their organisations for discussion (whilst maintaining confidentiality)
Just some of the benefits to be derived from this workshop include:
- Ability to more effectively assign ownership for key parts of manufacturing and distribution.
- Better understand how third party relationships can be fostered and advanced.
- Fulfil an effective role in developing Technical, Quality, Supply and Service Level Agreements.
- Influence issues that appeared to be outside control.
- Challenge other functions to prioritise quality and regulatory systems accordingly.
- Focus on the actions that can transform supply chain compliance.
- Reduce risk of delays and failure in getting drug to site or channel.
- Enhance control of inventory investment, availability and traceability.
- Appreciation of how to build shared understanding of quality and regulatory requirements within project management and launch teams.
- Increase confidence in helping drive continuous improvement through your supply chains.
