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Implementing a Bullet Proof Quality System for FDA Audit Success

Tuesday, June 23, 2020 10:00 AM PDT | 01:00 PM EDT

Training Duration = 60 min              Sponsored by ComplianceOnline

Click Here to register $199.00

Click Here to register and receive  recording $349.00

This webinar will provide an overview of the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness. It will also provide an understanding of the quality system inspection techniques (QSIT) requirements for documents controls, production and process controls, packaging and labeling controls and more.

Why Should You Attend:

This webinar will offer an overview of FDA expectations for medical device and combination product manufacturers for auditing their facility’s quality system. It will also cover key audit elements which will help attendees to set up their documentation in order to implement a bullet proof quality system to come out of FDA audits successfully.

Upon completion of this webinar, attendees will get an insight into all aspects of FDA audit requirements for medical devices so that they can prepare well and come out of the FDA audits without observations that can tarnish their product quality and marketing reputation.

Areas Covered in the Webinar:

  • Getting to know your Quality System (QS) in its entirety to fulfil FDA requirements for your QS
  • Familiarizing yourself with your products from R&D to cGMP production and documentation of the evolution of your commercialized product
  • Getting all your paperwork prepared per GDP (Good Documentation Practices) as evidence in order to withstand FDA scrutiny at the FDA audit
  • Understanding QSIT ( Quality System Inspection Techniques) requirements for:
    • Document Controls, Personnel and Training
    • Supplier and Purchasing Controls, Receiving and Shipping Inspections
    • Production and Process Controls and Corrective and Preventive Actions
    • Packaging and Labelling Controls, Test Equipment, Testing and Laboratory Controls, Out of Spec Testing Requirements

Instructor Profile:

Meena Chettiar is currently working as a Principal Product Development Quality engineer at Freudenberg Medical in Minnesota, USA. Meena has worked in several capacities over the past 20 years in several high level Quality and Regulatory Management positions at pharmaceutical and medical device companies such as ProMed Pharma, Covidien, Teva Pharmaceuticals and NAMSA. She has also worked as QC lab supervisor at Land O’ Lakes in Minnesota and for Agriculture and Health Canada in several technical capacities for about 10 years.