Manufacturing Authorisation Holder Responsibilities

November 30, 2022. 10:00AM EST/ 3.00PM IST

Orphan Drug Consulting is hosting a series of Quality Assurance webinars for the month of November. Our final webinar of the series will feature Martina White, Quality Consultant, and Kevin Lyons, Senior Quality Assurance Manager from Orphan Drug Consulting.

Join Martina White and Kevin Lyons as they present ‘Manufacturing Authorisation Holder (MAH) Responsibilities.’ In the second webinar, Kevin introduces the key elements of a Marketing Authorisation (MA), while Martina will further discuss the MA and the extensive responsibilities that the MAH has to comply with. The Orphan Drug Consulting team supports Marketing Authorization activities, ensuring your European MAH entity remains compliant with the obligations set forth by the regulators through the implementation of a cross-functional responsibility matrix for your company.

In the 15-minute webinar, the team takes you through the importance of obtaining an MA and the extensive responsibilities and regulations that an MAH must comply with.

Martina White is a Quality Consultant with over 13 years of experience in the pharmaceutical industry working across multiple areas of quality assurance. Martina has expertise in Quality, Qualification, and Validation and is an experienced Qualified Person. Martina has also held roles in manufacturing development where she led technology transfer projects and coordinated the supply of investigational medicinal products. Martina has experience with commercial product launches from a quality and validation perspective and has supported regulatory inspections across all her previous roles.

Kevin has over 15 years of experience working in the pharmaceutical industry through his role as a registered pharmacist. As Senior Quality Assurance Manager, Kevin brings a unique insight arising from his time working in patient-facing roles as well as his experience and training in GDP and GMP. He has experience throughout the product supply chain from working with product owners right through to end-users. Kevin is eligible to act as a Responsible Person/Deputy Responsible Person on behalf of clients.

About Orphan Drug Consulting Ltd
Orphan Drug Consulting coordinates product launches into the US, EU, and other international markets providing strategic support in the areas of supply chain, quality assurance, vendor management, and entity management with its team of experienced industry professionals. From full-service solutions to solving specific immediate requirements, Orphan Drug Consulting is your partner of choice to manage market complexities ensuring your successful product launch to meet your patient’s needs.

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