Canice Kearney, Takeda, Ireland
Sue Mann, Sue Mann Consultancy, U.K.
Hear and discuss the expectations and best practices for effective and efficient Quality Oversight processes and how to get there. This will support you turning your company’s quality excellence goals into reality.
Some Marketing Authorisation Holders but also innovative start-ups and Research & Development organisations outsource most, if not all, manufacturing, testing and distribution activities of their product(s) and are virtualizing their business. Quality Oversight in such a Virtual Company is challenging, but essential to ensure that products are safe, effective and of the correct quality.
There are some good reasons for such an approach. It gives smaller organisations the opportunity to bring their own product(s) to the market and keep the focus on research and development and it also helps attracting investors. The actual employees can concentrate on core competencies. For larger companies, it offers more flexibility and a good way to quickly add new products to the portfolio and develop markets faster.
Of course, such a business model also brings some challenges. One needs a high degree of trust with the business partners in the supply chain, must be able to deal with differences in corporate and quality culture and, above all, have the necessary oversight of the quality and supply chain of all activities and products.
Just as it is with other business areas, management has the responsibility to ensure that systems are in place to effectively monitor the state of control in order to intervene with timely decisions to manage risk, achieve goals, and add stakeholder value. It is of utmost importance to detect and heed possible problems early enough.
In 2021 EMA has published a reflection paper entitled "Good Manufacturing Practice and the Marketing Authorisation Holder", which was slightly updated 2022. The goal was to provide clarity on the different responsibilities and their practical significance for MAHs. Ultimately, the aim was to summarise and, if necessary, explain in one document the responsibilities that are described in various places in the relevant GMP documents such as the EU-GMP Guidelines or the respective Directives.
QA Managers and Executives from MAHs/ Virtual Companies including Senior Management and Business Executives and those involved in improving the Pharmaceutical Quality System.
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Quality and Supply Chain Oversight for Virtual Companies – what is different and what are the Challenges?
- What does quality oversight mean and what is expected?
- What aspects of the supply chain are relevant and how is sufficient oversight achieved
- How to handle more than one quality System
- How to manage differences in culture and language
Supply Chain Maps – Examples of Complexities involved
- What is required of a Supply Chain Map (SCM)
- Control and format of SCMs and setting the scope of responsibilities
- Achieving value from use of SCMs – and aligning company’s approach for supply
Specific Quality System Aspects for Virtual Companies
- General principles relating to virtual company quality Systems and how they should interact with other companies QMS
- Detailed review of likely points of interaction (e.g. Change controls, deviations/non-conformances, complaints & recall, preparation of the Product Quality Review, audits……)
- How to ensure effective and efficient interaction and communication.
- What are the challenges to overcome?
Batch Certification – Minimum Requirements & Best Practices
- Arrangements for QP Certification for virtual companies
- Manage deviation reporting and change control implementation in virtual companies
- Batch Certification – Considerations for Outsourcing
- Case studies, examples of effective arrangements
Use of Quality Risk Management
- Objective of QRM and how best to use this tool
- When to use proactively and how to ensure this is effective
- Examples of when QRM has to be used reactively and how to make informed, scientific decisions
Marketing Authorisation Holder (MAH) Responsibilities
- The ultimate responsibility for the performance of a medicinal product
- Articulating MAH responsibilities in a complex organization
- Effective MAH governance
Post Product Release Oversight Responsibilities
- Virtual companies’ responsibilities after certification and release of medicinal product
- Establishing arrangements for effectively managing defect reporting, potential market actions, supervisory authority engagement
- Reminder of GDP guidance available for APIs and products
- How this interface should work to ensure product reaches patient in suitable condition
- Challenges to overcome when working in a virtual company
Questions and Answers Session
A set of live Q&A Sessions will give you the possibility to interact with the speakers and get answers to your Questions.