This webinar is important to the industry as all the regulations require quality assurance of the materials, components, and services that impact or are used for the final product configuration. In addition, supplier qualification is a critical portion of the quality system requirements (21 CFR 820), and companies must demonstrate control over their suppliers and the materials or services provided by them. This webinar will review the regulatory aspects of this program such as purchasing controls, evaluation of suppliers, contractors and consultants along with discussion of recent deficiencies found during their review by the inspectors.
A common approach to defining the level of control for suppliers is a risk-based approach where the higher the risk, the greater the level of control exerted. This can then be translated into whether or not on-site audits, mail-in audits or no audits are required. The webinar will provide a check list of items to be evaluated when selecting a potential supplier, and the topics to be included in a supplier agreement to answer the questions of what, when, how and who. Attendees will be given ample opportunity to ask questions regarding their current approach or to share ideas for improvement.
Attendees will walk away with not only the regulatory requirements for supplier agreements but a template of topics to use to evaluate or develop their own agreements.
- Current regulatory requirements for supplier agreements as found in 21 CFR 820
- Common topics to evaluate when conducting a risk-based supplier qualification
- Typical things that should be covered in supplier agreements and the quality standards that should be examined
- Review of the typical “tools” that companies should use to assure control of their suppliers and issues relating to the handling of changes
- Engineering Departments
- Manufacturing Departments
- R&D Departments
- Quality Departments
- Operations Departments
- Supply Chain Departments
- Purchasing Departments
- cGMP auditors