Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Event Details

Filter
WorldWebinar

How to prepare for and host an FDA inspection and respond to 483’s


Add this event to your calendar: iCal   Google Calendar

Details

OVERVIEW

In this webinar you will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the FDA inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and techniques for responding to 483s and warning letters. How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them.

WHY SHOULD YOU ATTEND

FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483’s than a disorganized company.  If a 483 is received knowing how to respond will lessen chances of receiving an FDA warning letter.

AREAS COVERED

  • Personnel preparation
  • Procedure to follow during FDA audits -what to do/ what not to do
  • Facility requirements to support FDA inspection
  • Behavior during inspection-what not to sign
  • Internal/ mock audits
  • 483s/ FDA Warning Letter response

LEARNING OBJECTIVES

Learn how to handle an FDA inspection efficiently. Also learn effective strategies to avoid 483s as well as for responding to an FDA warning letter.

WHO WILL BENEFIT

  • Engineering personnel
  • Engineering management
  • Quality/ regulatory Management
  • Corporate Management
  • Manufacturing Management
  • Division management
  • Legal counsel

For more detail please click on this below link:

https://bit.ly/2xDpkDI

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 

Prices

Live Session for one participant $129 Corporate Live Session Group – Max 10 Participants from one location. $299 Recorded Session Get unlimited access to the link for six months. $149 Training DVD or USB Flash Drive MP3 files, PDF presentation and reference manual will be delivered on a CD $249 Super Combo Offer 1 Live and Recorded webinar $199 Super Combo Offer 2 Live and Training CD $299

Contact

Training Doyens
support@trainingdoyens.com

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.