This webinar covers the importance of oversight for contract manufacturing, packaging, and testing. The responsibility ultimately lies with the MAH or CT Sponsor, who must ensure that quality, safety, and efficacy requirements are met.
We’ll guide you through ongoing assessments and reviews, product quality reviews, risk assessments, audits, communication requirements, engagement with partner organizations, contract establishment, and agreement drafting.
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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