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:
Who Will Benefit:
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.
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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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