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FDA Establishment Inspections - What to Expect?

 
 

In this FDA Inspection webinar attendees will learn about the FDA inspection process & the effective techniques how you and others behave and interact with FDA inspectors during an

FDA Establishment Inspections - What to Expect

 

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  • 1x Person - Unlimited viewing for 6 Months

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  • One CD or USB is for usage in one location only

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  • LIVE + RECORDED VERSION

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  • LIVE + TRAINING CD or USB

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About The Event

FDA Establishment Inspections - What to Expect?

 
 
In this FDA Inspection webinar attendees will learn about the FDA inspection process & the effective techniques how you and others behave and interact with FDA inspectors during an FDA Establishment Inspections.

Why Should You Attend:

The Food, Drug, and Cosmetic (FD&C) Act gives FDA the authority to conduct inspections at drug and medical device manufacturing facilities as well as other regulated industries. Those companies manufacturing drugs and higher risk medical devices, are prime candidates for inspections. Facilities having historical significant violations, are also FDA inspected.

If you are in any regulated business you will at some time experience an inspection by the U.S. Food and Drug Administration (FDA). According to the Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Depending upon the inspection type and the circumstance, inspections may occur more frequently. The outcome of those inspections can have a grave significant impact upon your business even if you and your colleagues have done everything “right.” How you and others behave and interact with FDA inspectors can have an impact on the results reported. Interacting with inspectors is not an natural behavior, effective techniques must be learned and mastered if those inspections are to have positive outcomes.

Areas Covered in the Webinar:

  • The inspection process – what to expect
  • Importance of truthfulness
  • Importance of knowledgeability and confidence
  • FDA Tricks to elicit information
  • Arguing and challenging
  • Behavior during the inspection
  • Importance and role of documentation
  • Effective communication skills
  • Being deceptive
  • Opinion versus fact
  • Phrases never to say
  • Handling adverse findings during the inspection

Who Will Benefit:

This is an all-inclusive webinar benefiting all individuals within the organization but particularly those in positions of management and supervision. Vice Presidents, Directors, Associate Directors, Managers and Supervisors as well as associates in ALL functions will benefit from this organization. Significantly, compliance and regulatory who spearhead the inspections and are responsible for compliance readiness, as well as training that should be building on-going training around this subject should also be included.

Instructor Profile:

Charles H Paul

Charles H Paul
President, C H Paul Consulting Inc

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars in a variety of related subjects from documentation development to establishing compliant preventive maintenance systems. The firm works globally completing projects throughout the EU, UK, South America, and Asia.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.