Participants will gain an insight into how to manage and plan new supplier and contractor qualifications from agreement right through to making the final decision on acceptance. The webinar will also provide tips and hot topics for qualification audits in order to better prepare the potential auditor.
We will cover the most significant updated and new guidelines in the past 12 months, including the following:
- New Suppliers – initial feasibility and assessment
- Down selecting and planning further qualification
- Qualification Audits – Types and what to look for
- Follow up and making the final recommendations
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 Sponsor
The Qualifyze mission is to build the trust layer for global supply chains by creating a digitally connected ecosystem. They operate the first online platform for GxP audits that connects pharma companies, suppliers, and auditors.
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