Preparing for FDA Audits and Responding to FDA 483s in Pharmaceutical and Medical Device Industries

Duration: 60 Minutes
During this information-packed webinar, quality and regulatory professionals in the FDA regulated pharmaceutical and medical device industries will learn the key steps for being inspection ready for FDA audits, which can make or break your company based on how your Quality Management System (QMS) can withstand the scrutiny by the FDA auditors. The presenter who has participated in several FDA audits in both Pharmaceutical and Medical Device industries at the senior management level and as a facilitator of the FDA audits has a tremendous insight into the FDA Audit process.
FDA Audit Process
Instructor: Meena Chettiar
Product ID: 508860
Objectives of the Presentation
  • Bullet proof your quality system through careful preparation for the FDA visit
  • Learn want to expect during the FDA audits
  • Learn how to respond to major non-conformances presented as 483s by the FDA auditors
  • How to respond to the FDA 483s, learn and grow from them
  • How mock QSIT audits performed by experienced auditors can escalate your preparedness
  • In summary learn what to expect from FDA audits, how to respond to FDA 483s and warning letters with confidence and nurture your quality system on an ongoing basis
Why Should you Attend
  • FDA regulated Pharma and Medical Device industry's top management, Quality Directors, QA/QC Managers, Senior Quality and Manufacturing Engineers and QA and Regulatory Personnel should attend this session to learn about what FDA Inspectors look for when they audit your company.

  • Preparation and planning that is indispensable to make this audit painless and what is expected of you when you are handed out a non-conformance as a 483 is the key reason for you to attend this unique session packed with practical information. The presenter will share her experiences from the several FDA audits that she has been fortunate to be part of in the FDA regulated industries in the United States and her experience in preparing companies for FDA pre approval and follow up inspections before and after 483s. The earlier you learn the FDA rules and expectations; the better off you will be in setting up and maintaining a bullet proof quality system.

Areas Covered
  • General information on FDA audits including sample 483s
  • How can you prepare for FDA audits right from your product design stage
  • Documentation requirements for all elements of your QMS
  • What can one do during the audits to show off your quality and compliance to FDA inspector
  • Mock FDA audits and QSIT audits for pharma and device industries respectively
  • How can you recover from FDA 483s and use them to learn and grow your product compliance and extend the lessons learned to your entire product line
Who will Benefit
  • VP of Quality
  • Director of QA/QC
  • Manufacturing Directors and Managers
  • Regulatory and Compliance professionals
  • Quality and Manufacturing Engineers
  • R&D and product development professionals
  • FDA Consultants
  • Public Relations Professionals
  • Sales and Marketing Executives
  • Manufacturing Executives
  • Design Engineers
  • Third Party Consultants
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ms. Chettiar has a very strong background in Quality in the FDA regulated industries. Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A. SC in Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar is also very knowledgeable in Clinical Research auditing for medical devices and pharmaceutical products.

Meena is currently working as a Senior Associate at NAMSA and is the Founder and Principle Consultant of MNQ Consulting Services LLC. Meena has worked as Quality and Regulatory Manager at ProMed Pharma, Medical and combination device manufacturer, a Senior Supplier Quality Engineer for Covidien with drug coated balloons and guide wires, for Baxter Bio Surgery, as a Senior Quality Manager at Teva Pharmaceuticals for over 10 years and as QC lab supervisor at Land O' Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years. Meena has performed mock QSIT Audits and has responded to several FDA 483s.

Meena has played a key role in quality system implementations in the food, pharmaceutical, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US, Canada, Puerto Rico and Costa Rica. Meena is the Chair elect for MNASQ (American Society for Quality) this year. Meena is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence).

Meena has served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana and is very passionate about Installation and growth of Quality Systems in general.
View More