This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.
Why Should You Attend:
Good Manufacturing Practice regulations, which have the force of law, require that manufacturers, processors, and packagers of medicinal products take proactive steps to ensure that their products are safe, pure, and effective. cGMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors.
Personnel involved in cGMP must have documented training of current Good Manufacturing Practices (cGMP) training. This webinar will focus on the FDC Act and 21CFR federal regulations as applied to cGMP and provide an overview of the US FDA regulations for compliance.
Areas Covered in the Webinar:
Companies in the pharmaceutical and medical device space are required to have control over their supply chain and suppliers. Suppliers make changes to their product, production or location on a routine basis. The manufacturer needs to assess the impact of those changes on their product and or production before introducing the vendors product into their manufacturing process. This webinar will discuss setting up good supplier agreements so change notifications are received and how to do a proper impact assessment of those notices before accepting altered product.
All companies in the pharmaceutical and medical device space are required to have control over their supply chain and suppliers. Inadequate assessment of changes to supplier material, production or location can have impact on final product, process and/or regulatory impact. This training will highlight ways to assess the impact of supplier changes to help mitigate impact.
Areas Covered in the Webinar:
- Regulatory Expectations
- FDA
- ISO
- Supplier Agreements
- Continuing guarantee statements
- Supplier Change Notices
- Assessments of Supplier Change Notices
- Procedures
- Team
- Triage
- Types of changes
- Low/No Impact Changes
- All other changes
- How to determine which is which
- Full impact assessments of changes which do not fall into the Low/no impact category
- Level of work based on risk
- Team approach
- Tools
- Determination of acceptability of change
- Acceptable change
- What to do if change is not acceptable
Instructor Profile:
Kelly Thomas
Head Of Quality Assurance, Veru Inc
Head Of Quality Assurance, Veru Inc
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.