Quality Oversight of Pharmaceutical Contract Manufacturing Organisations
14/15 October 2026, Vienna, Austria
Course No. 22558
Speakers
Canice Kearney
Takeda Ireland
Dr Sue Mann
Sue Mann Consultancy
Energy Kristina Hansen
MilCor Consulting
Dr. Friedemann Scheck
Roche
What MAHs and Virtual Companies need to know
Requirements and Responsibilities
Challenges and possible Solutions
Quality System Aspects
Target Group
QA Managers and Executives from MAHs/ Virtual Companies
Senior Management and Business Executives
Outsourcing and Purchasing
Objectives
Discuss expectations and best practices for effective and efficient Contract Manufacturing Organisations (CMO) Quality and Supply Chain Oversight processes.
Strengthen awareness of the risks and opportunities associated with outsourcing models.
Share best practices for managing differences in quality culture and with difficult CMOs.
Programme
Highlights of the Course
Requirements and responsibilities
Challenges and possible solutions
Quality System aspects
Supply Chain Maps
Dealing with difficult CMOs
GDP interface
CDMO Oversight: case study on IMPs
Regulatory Background and Requirements
What does ‘Oversight’ mean?
Applicable GMP requirements when working with CMOs
Which are the essential Pharmaceutical Quality Systems (PQS) elements?
The ultimate responsibility for the performance of a medicinal product
Articulating MAH responsibilities in a complex organization
Effective MAH governance
Quality and Supply Chain Oversight when working with CMOs - – what is different and what are the Challenges?
What does CMO 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
Interactive Session: What is needed in your Organisation? (Specific Quality System Aspects)
How the PQS should interact with other companies’ systems
Detailed review of possible 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 at the contract giver
Manage deviation reporting and change control implementation
Batch Certification – Considerations for outsourcing
Case studies, examples of effective arrangements
Case Study IMPs: CDMO Oversight at Roche
Responsibilities
Contract Development and Manufacturing Organisations (CDMO) selection and control
Overview management
Point of contacts
Reviews and quality reports (external/ internal)
Dealing with difficult CMO Stakeholder Behaviour
Top 10 most difficult behaviours to handle
Reasons
How to increase engagement
CMOs needing high Level of Oversight
Triggers, figures and stickers
Handling below satisfactory CMOs
Use of Quality Risk Management (QRM)
Objective of QRM and how best to use this tool
When to use QRM proactively and how to ensure this is effective
Examples of when QRM has to be used reactively and how to make informed, scientific decisions
Post Product Release Oversight Responsibilities
MAH’s responsibilities after certification and release of medicinal product
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
Question and Answer Sessions A set of Q&A Sessions will give you the possibility to discuss your issues and get answers to your questions.
Further Information
Venue Austria Trend Parkhotel Schönbrunn Hietzinger Hauptstr. 10-14 1130 Vienna, Austria Tel.: +43 (1) 878 08 0 E-Mail: parkhotel.schoenbrunn@austria-trend.at
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG after registering for the course. Reservations should be made directly with the hotel. Early booking is recommended.
Social Event On 14 October, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees ECA Members EUR 1.890.- APIC Members EUR 1.990.- Non-ECA Members EUR 2.090.- EU GMP Inspectorates EUR 1.045.- per delegate plus VAT The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments.VAT is reclaimable.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
