The expectations for quality remain the same for batches produced continually vs. bath-to-batch. However, the quality unit must transition to a very different control strategy to ensure product quality. This webinar will discuss quality and compliance considerations for continuous manufacturing as per the FDA draft Guidance for Industry (Quality Considerations for Continuous Manufacturing, February 2019) and with input from other FDA Guidances and ICH documents. The content is intended for small molecule solid oral drug products, but concepts can be applied to other products.
Are you ready to assure product quality when your company recognizes the financial value in continuous manufacturing? The FDA expects you to factor in previous guidances on quality by design, risk management, and process analytical technology setting up a complex matrix of expectations. During an inspection, you will need to be able to speak to all of these requirements and to assure investigators that you have set up an excellent risk-based control strategy for continuous manufacturing.
Continuous pharmaceutical manufacturing can greatly increase efficiency, saving time and money over batch-to-batch processing. This includes the potential for fast product release through real time release testing and computer-based batch records with automated quality assurance decisions.
It can be daunting for a quality assurance department to transition to the new challenges of quality assurance for continuous manufacturing. The hazards identified and the control strategy can be completely different. In particular, the quality unit must ensure that batches are defined appropriately, raw materials are traceable, control parameters are adequately set, process disturbances are handled correctly, process validation is acceptable, the cleaning frequencies and processes are adequate and validated, and changes (including scale-up) are managed appropriately.
This webinar will teach you how to build quality into the design of your process, how to know when your process is in control, how to manage testing and release, and how to manage changes. It will also highlight ways to meet the challenges to product quality and to compliance inherent in continuous manufacturing processes.Areas Covered in the Webinar:
Senior Consultant, Quality GMP Solutions LLC
Peggy Kwoka has more than thirty years of experience in pharmaceutical, cosmetic consumer health and medical device industries including twenty years in Quality Assurance management and consulting. She has managed or provided expertise for more than ten US FDA inspections.
Peggy is currently working with pharmaceutical companies to develop effective quality systems through her consulting firm, Quality GMP Solutions, LLC. She focuses on improving her client’s manufacturing and quality processes to enhance their regulatory compliance profile. She previously held quality assurance management roles at Colgate-Palmolive Company and GlaxoSmithKline.
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. FDATrainingAlert 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.
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