FDA Drug Inspection Trends and Remediation Strategies: Process Validation Live Webcast
FDA has issued a number of process validation-related Warning Letters in 2017. This webcast will review a number of Warning Letters and provide specific remediation strategies for each situation, so that your company can be prepared for regulatory agency inspections in 2018.
Live Webcast Recording
Why Should You Attend
FDA has issued a number of process validation-related Warning Letters in 2017. This webcast will review a number of Warning Letters and provide specific remediation strategies for each situation, so that your company can be prepared for regulatory agency inspections in 2018. Topics will include:
- Developing an ongoing program to monitor process control and detect variation
- Determining when revalidation is necessary
- Writing a Warning Letter response to FDA-inadequate versus an adequate response
- FDA expectation: Components of a “data-driven and scientifically sound program”
- Review of key components for an effective validation program, including
- Written procedures/SOPs
- Management commitment
- Validation Master Plan
Who Will Benefit
Professionals directly involved in the development and manufacturing of drug products, biologics and medical devices, including:
- Quality Assurance/Quality Control
- IT Professionals
- Technical Operations
- Process Development
For Customer Care and Group Discounts – Please Contact Us
Phone: (+1) 844.686.5750
Danielle DeLucy is an industry veteran and specializes in the areas of Quality Assurance and Quality Systems as a consultant. Prior to this role, Danielle has been in the industry for 15 years, serving in numerous quality management roles, such as the Director of Product Quality, with oversight of sterility assurance practices and numerous filling and packaging operations. Danielle began her career as a Quality Control pharmaceutical microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the quality management arena, including leading many regulatory health inspections, and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who: 1) are faced with Warning Letters and consent decrees; 2) wish to improve GxP practices; and 3) need to establish more robust quality systems.
Registrants may cancel up to two working days prior to an on-line course or webinar start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. On-site training can be cancelled up to ten business days prior to training. Windshire will be compensated for any travel cancellation fees. Courses and webinars may be cancelled due to unavoidable factors. Registrants will be notified if a cancellation occurs. Attendees can choose between the recorded (on-demand) version of the webinar or a full refund for any Windshire cancelled webcast.
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