The Hitchhiker’s Guide to 483s and Warning Letters – FDA Compliance Trends, Response and Prevention |Oct. 15, 2015, 1 PM EDT | Bazigos
June 10th, 2014 // 1:13 pm @ jmpickett
In this light, entertaining but rigorous Webinar by Angela Bazigos, CEO Touchstone Technologies, presenter of our other excellent webinar on writing FDA compliant SOPs, you will learn the very latest in FDA compliance trends, how to respond to an FDA 483 and warning letter, and how to prevent them from occurring at all.
Any regulatory professional who works in the pharmaceutical, medical device or biologics industry always fears getting an FDA 483 or warning letter.
But don’t panic! This highly informative webinar will help!
What You Will Learn:
- 483 and Warning Letter Policies – when and why FDA issues these documents
- Recent Trends in 483s as of 2012 – Major failure areas in the last five years
- The Number of 483s Issued by FDA in All Areas – 2012
- How to Effectively Respond to a 483
- Warning Letter Red Flags
- Why You Must Respond Effectively to a Warning Letter – FDA now goes straight to punitive action – multiple warning letters are rare
- Big Differences Between 483s and Warning Letters
- FDA Enforcement Statistics for 2011
More What You Will Learn:
- How to Avoid 483s and Warning Letters
- Remove Low Hanging Fruit – SOPs, Training, Calibration
- Pay Close Attention to cGMP Regulations – upper management!
- Do NOT Overwhelm the FDA Inspector!
- SOPs Are a Huge 483 Problem – how to make sure yours are compliant
- Calibration and Training Record Tips
- 21 CFR Part 11 Tips – Excel Spreadsheets
- How to Conduct Excellent Self-Audits
- Most Common 483 Observations and How to Prevent Them
- Importance of Responding to FDA 483 in 15 Days
- How to Write an Effective Response Letter
- Examples of Effective 483 Observation Responses
- 483 and Warning Letter Response Best Practices
- 2 Hour Webinar, Including 15 Minute Q&A
- Powerpoint Slides
- Free Recording Download of Webinar (CD available at no extra cost)
- Free Article – 21 CFR Part 11 Enforcement – Where Is FDA Headed? By John Avellanet, Cerulean Associates
- Free Guide – An Executive Guide to Quality by Design – By John Avellanet, Cerulean Associates
- Free Newsletter – FDA Digest – By Expertbriefings.com. Latest FDA regulatory news, and recent 483 and warning letter analysis – 12 issues only $399.00
- Certificate of Attendance – Webinars May Be Used for Continuing Education Credits!
About Speaker
Angela Bazigos has been accepted into the prestigious ranks of Stanford Who’s Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world.Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Complianceâ€. She has 30 years experience in the Life Sciences industry spanning project management, Quality Assurance and Regulatory Affairs. She has applied for patents aimed at speeding up Software Compliance and FDA Audits.Angela is a member SQA (Society of Quality Assurance) as well as of the SQA CVIC (Computer Validation Initiative Committee), DIA and RAPS. She provides consulting services to Pharma, Biotech, Medical Device and CRO industries on compliance matters, including strategy, submissions, quality assurance, computer systems validation, and remediation’s following action by the FDA. She also teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management.
More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research, Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is also on the board for UC Berkeley’s Haas Business School for Executive Education in Life Sciences.
Price: 1 Webinar Seat $99 (Contact Us for Multiple Webinar Seats)
