How to Effectively Audit Suppliers and Contractors for Initial Qualification
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Assessing new suppliers and new contract manufacturing, packaging, and storage site auditing is vital to an effective GMP quality management system. It ensures that we properly evaluate and qualify the contracted-out parts of our quality system, remain compliant with our regulatory obligations, and ultimately safeguard our products’ quality, safety, and efficacy.
The need for new suppliers and contract partners is usually driven by new product launches or technology transfer proposals due to cost or quality implications. Quality Assurance must be involved in the decision-making process at a very early stage as there will be a need to assess the technical capability to supply the raw material or to manufacture according to a registered process.
ICHQ10 states that the pharmaceutical company is ‘ultimately responsible for ensuring processes are in place to assure the control of outsourced activities and quality of purchased materials.’ Therefore, it should be no surprise that our regulatory inspectors focus on how we achieve this and will pay particular attention to companies applying for new virtual manufacturing or wholesaling authorizations.
This webinar will teach you what quality and technical assessment you should perform when selecting a raw material supplier or contractor. Then, we will explore the next steps you should undertake based on the initial assessment of your Quality Management System.
In most cases where the material or a contracted service is critical to product quality, safety, or efficacy, you would engage further with the site and complete a formal qualification. For this reason, we will also explore what you must consider with such critical suppliers.
Overall, in this 1.5-hour webinar, we will give you the specific auditing requirements for initial supplier/contractor qualification and the tools and knowledge you need to plan out these audits. We will also cover what to look for throughout the process and when reviewing key documents and quality systems requirements such as SOPs, Validations, Change controls, and investigations.
Register now and join us on 28 Mar 2023 to ensure you are equipped and prepared to handle new supplier and contract manufacturer qualifications as part of your audit program!
Who Should Attend:
- Supplier Quality Specialists
- Compliance Managers
- QA Managers
- Regulatory Managers
- Heads of Quality
- Skill Level: Intermediate , Expert
15:00 – 15:10 Introductions
15:10 – 15:15 New Suppliers – initial feasibility and assessment
15:15 – 15:25 Down selecting and planning further qualification
15:25 – 15:45 Qualification Audits – Types and what to look for
15:45 – 15:55 Follow up and make the final recommendations
15:55 – 16:00 Summary and questions
Special event information:
All live participants will receive a free certificate of attendance courtesy of the event's sponsor, Qualifyze.
Charley MaxwellManaging Director & Consultant QP / RP
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.
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