Good Manufacturing Practices: Annex 21

November 16, 2022. 10:00AM EST/ 3.00PM IST

Orphan Drug Consulting is hosting a series of Quality Assurance webinars for the month of November. Our first webinar will feature Sharon Cullen, Head of Quality, and Martina White, Quality Consultant from Orphan Drug Consulting.

Join Sharon Cullen and Martina White as they present ‘Good Manufacturing Practices Annex 21’. Annex 21 of the EU-GMP Guidelines was drafted in 2020 and has come into effect this year. Annex 21 defines the fundamental rules and regulations for Manufacturing Import Authorization (MIA) holders who import pharmaceuticals (human and veterinary) across EU/EEA borders. The Orphan Drug Consulting Quality Assurance team has the most up-to-date information on EU regulations and can guide your company through any changes required for your organization to comply with new regulations.

In the 15-minute webinar, the team gives a detailed explanation of what Annex 21 is, its purpose, and how the new regulation will affect your company now and in the future.

Sharon Cullen is Head of Quality for Orphan Drug Consulting, she has extensive experience in senior leadership roles in the Life Science industry with a focus on the Pharmaceutical Quality System (PQS) including auditing, regulatory inspections, lean and continuous improvement, compliance, quality excellence, training, management review, CMO oversight, quality data integrity, analytics and enabling technologies, affiliate quality oversight, and global quality operations including QP responsibilities, QC laboratory, and packaging.

Martina 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. 

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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