This Webinar will focus on how to use SMART goals as a framework to draft submission-ready GCP and/or GVP CAPAs that not only adequately address observations but are also practical given your organization’s unique goals and challenges. Anecdotes and examples will be provided to lend context, and tools shared to give you the confidence to write successful CAPAs.
How CAPAs are written is key for gaining agreement with internal Quality Assurance Groups, clients and/or regulatory authorities. Poorly-written CAPAs can lead to confusion and – worst of all – repeated observations. In a pharmaceutical GCP and GVP environment, just about any group, team, or individual can find themselves in the hot seat during audits and regulatory inspections. Despite all audit and inspection readiness efforts, an outcome of zero audit observations are rarely seen. Companies are less likely to receive an official list of minor inspection observations to which they must respond; however, we all dread being handed major or critical observations from regulators.
If faced with that scenario, after the initial shock of your observations wears off, robust Root Cause Analysis (RCA) is conducted and an appropriate Corrective and Preventative Action (CAPA) is determined. After all that work, one of the worst possible outcomes is having a repeat major or critical audit or inspection observation because your CAPA failed to address the issue.
This Webinar will provide specific instruction, tips, and tools on how to use SMART (Specific, Measurable, Achievable, Results Oriented, and Time-Bound) goals as a framework to draft submission ready GCP and/or GVP CAPAs that:
At the completion of this session, you will be able to
This course will benefit employees of all levels within biopharmaceutical companies that are developing and executing global and/or domestic CGP and/or GVP-regulated clinical research and development programs and trials. Senior managers responsible for overall clinical research and development strategy will benefit as well as employees managing clinical trials, clinical (and postmarking) safety, clinical and PV quality assurance, the inspection process, and/or develops/manages processes that fall under GCP and GVP expectations. This includes personnel in:
CEO, PDC Pharma Strategy
Penelope Przekop is a Pharma R&D & PV Quality Systems Engineer and Quality Assurance/ Systems & Compliance Consultant with more than 25 years of experience in Pharmaceutical & Biotech GXP Global Quality Systems. My growing consulting focus is the development and implementation of practical, risk-based quality systems/compliance strategies for pharma and biotech companies that support corporate goals not only during development but also through submission, product launch and beyond.
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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