Stephanie Cooke is the President & CEO of Cooke Consulting, Inc., using her 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biopharmaceutical, medical device and nutraceutical firms. Her b Read more
This webinar will discuss the requirements for handling deviation based on GMPs, ICH guidance documents and other relevant guidance. It will also explain ICH Q8, Q9, and Q10 guidance documents and will provide best practices to ensure compliance with these documents in regards to handling deviations and nonconforming products.
This webinar will address the handling of deviations in the manufacture of the final drug product and will address the global requirements for handling of deviations and for nonconforming products, as well as the direction of relevant ICH and FDA guidance and other relevant documents will be discussed.
In addition, the increased focus on nonconforming product handling, as well as handling of deviations and increased focus on improved process understanding and opportunities to implement continual process improvement throughout product lifecycle and risk-based systems will be discussed.
• Review of agency actions when these issues are not appropriately handled and consequences.
• Criteria for handling deviations and nonconforming products to be in compliance with current requirements and practices, based on ICH Q8, ICH Q9, ICH Q10, GMP and other appropriate documents
• Understand the application of systems to assure that your process is consistently producing product that meets specifications through appropriate implementation of CAPA system, Change Management system
• Handling of non-conforming product, including all SOPs that are required to be in place that define the need for an investigation of nonconforming product, notification of persons or organizations responsible for the nonconformance, procedures defining the documentation of the evaluation and investigation of nonconforming product.
• Procedures describing the rework of nonconforming product that are required to be in place prior to encountering a need to rework and reevaluate your product will be defined, including SOPs stating the procedure for retesting and reevaluation of nonconforming product after rework to ensure that the product meets its approved specifications and to evaluate potential adverse events following rework of a nonconforming product, as well as documenting all aspects of nonconforming product rework will be discussed.
• Identifying compliance of your CAPA or Systems for handling deviations or information resulting from process and product issues which can be used to continually improve product quality will be discussed.
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Quality management personnel
• Quality personnel/Quality control unit personnel
• Regulatory affairs professionals
• Production personnel
• Quality Auditors
• Compliance professionals
• Quality engineers