Learn how to access the European market and launch your product flawlessly!
We will cover the most significant updated and new guidelines in the past 12 months, including the following:
- Basic Licencing requirements
- Supply models and associated partner / Org requirements
- QMS Elements – what is needed for each license
Modifying global procedures to incorporate EU regulations - Summary and questions
Speaker
Managing Director & Consultant QP / RP
Charley Maxwell
Charley is the owner and Managing Director of Orion GXP Consulting. He has over 20 years of experience working in manufacturing QA, regulatory compliance, batch release, and distribution in the pharmaceutical and medical device industry. He has assisted multiple clients with designing, developing, and implementing phase-appropriate Quality Management Systems, vendor management, audit programs, quality risk management, and training. Charley has a Bachelor’s of Science In Biochemistry and a Master’s In Pharmaceutical Manufacturing Technology. He has acted as a QP in Ireland for sterile and non-sterile manufacture, clinical IMP release, and third-country Importation.
Webinar Partner
Orion GxP Consulting provides contract QP and RP services and consultancy support to pharmaceutical manufacturing and distribution clients, such as training and expert knowledge. Orion GMP Consulting draws on the experience of our consultants and their links to the pharmaceutical industry through consulting and QP/RP roles to assist their clients in developing, managing, and continuously improving their quality systems.
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