Ensure successful FDA/Global Site Inspections and Maximize Potential Regulatory Opportunities by establishing effective Pharmaceutical Quality System (per ICH Q10 guidance document)


Instructor: Stephanie Cooke
Product ID: 705477

  • Duration: 90 Min
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.
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Why Should You Attend:

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.

Areas Covered in the Webinar:

  • 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.

Who Will Benefit:

  • Quality management personnel
  • Quality personnel/Quality control unit personnel
  • Regulatory affairs professionals
  • Production personnel
  • Quality Auditors
  • Compliance professionals
  • Quality engineers
Instructor Profile:
Stephanie Cooke

Stephanie Cooke
Consultant, Cooke Consulting, Inc

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 broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical and biotech products, drug/device combination products and medical devices in all stages of development (INDs, NDAs, post-marketing, orphan drug submissions, 510ks, PMAs and HDEs). She also has extensive QA and validation experience, hosting many compliance audits conducted by FDA, ISO and other international regulatory bodies, conduct/management of auditing program to qualify contract manufacturers and vendors of raw materials, APIs, product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for QMS for all product types (CAPA, Complaint, Document Control systems), stability programs, as well as preparation/performance of manufacturing process validation, sterilization validation (EtO, steam, gamma), aseptic processing, qualification of cleanrooms/water systems and qualification of equipment.

Stephanie worked for Scīele Pharma from 2005-2009 and was VP of Regulatory Affairs, Quality Assurance/Validation for Scīele, leaving in 2009 to start Cooke Consulting. She also held various senior RA, QA and validation positions at Merial, Bayer, Cryolife, Theragenics and other pharmaceutical, biotech and device companies, after beginning in industry as a lab tech and as a certified as a Microbiologist. She has a BS in Biology and an M.S. in Molecular Genetics and Biochemistry.

Topic Background:

FDAs recent announcement on August 31, 2018 notified the industry about implementation of a change in FDAs structure to align field and review staff so that the agency “can make closer consideration of all elements that create risk including the drug substance, the drug product, manufacturing processes, and the state of the facilities we regulate”. In addition to FDAs recent announcement of this change in the structure of staff in order to better align itself to be able to focus more on elements that create risk and also focus on improvement and better understanding of the manufacturing process, several ICH Harmonized Tripartite Guidelines such as ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System) and others reflect the global shift in the approach to evaluating and using knowledge gained throughout all stages of the lifecycle, including post- marketing.

Knowledge gained during post-marketing, during routine manufacturing, such as information gathered in the handling of deviations through the CAPA system and information resulting from investigations arising out of this information and information from investigating instances of nonconforming pharmaceutical product should be used to continually improve product quality throughout the entire product lifecycle and the emphasis on true understanding and continual improvement of the manufacturing process and risk-based approaches have definitely changed the way in which auditing of facilities and processes is being handled.

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