CAPAs are an integral part of any continuous improvement system. So, if you don’t want your processes to become stagnant and risk falling behind innovative technologies and your competitors, you need a fool proof CAPA process.
Half of the effectiveness of your CAPA depends on how well you write it. In this advanced compliance writing webinar, you will learn how to ensure that your corrective and preventive action plans are valid. Discover the key adjustments you need to apply to your failure investigation techniques and root cause analysis to ensure your CAPAs are effective in preventing recurring issues.
Take-Aways
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Life Sciences Regulatory Consultant
Meritz & Muenz LLP
Judith Meritz has more than 30 years of experience representing pharma and medical device companies. She specializes in strategic planning and compliance mediation concerning the FDA and other international regulatory agencies. She has held key regulatory and legal positions for companies including Medtronic, Covidien, Henry Schein and the American Red Cross. She chaired the medical device practice at two Washington DC law firms. She has been the key player in interactions with the FDA and drafted inspection responses to numerous FDA 483’s and warning letters. She has led companies to achieve successful outcomes and avoid further enforcement actions. She taught at the FDA CDRH college on inspection readiness and adverse event corrective actions.