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Validity : 15th Apr'24 to 25th Apr'24
Responding to FDA 483s and FDA Warning Letters - Best Practices
This presentation will use humor to describe:
- Why the FDA issues such citations
- What is a 483 and what does it look like
- What is a Warning letter and what does it look like
- What is the difference between a 483 and a Warning Letter
- What they mean for your company
- How to respond to 483s and Warning Letters to avoid escalation by the FDA
- How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters
Overview of the webinar
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical/biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
Who should attend?
- CEO
- Regulatory VP
- Quality VPs
- IT VPs
- Regulators
- Regulatory Affairs professionals
- Quality Managers
- Quality Engineers
- Small business Owners
- GxP Consultants
Why should you attend?
A fun way to present this serious topic!!
Whether your business can affect drug safety and effectiveness, Cosmetic and Medical specialized and consumer products your business is regulated by the FDA. With the FDA regulating a trillion worth of products each year, it is no wonder that audits by the FDA are perhaps the most intimidating of all events at a regulated facility.
483’s and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection. In 2011 alone, there was 9288 product recalls, 16 Injunctions and 15 seizures. Can you afford not to be prepared?
Faculty - Mz.Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.