We use cookies to personalise content and ads, to provide social media features and to analyse our traffic. We may also share information about your use of our site with our social media, advertising and analytics partners. Read more about our Privacy Policy.

I got it!

Webinar On FDA Inspection Preparation and Readiness

The Top 20 Most Common GMP Deficiencies for Device Manufacturers

Description : This webinar is intended to discuss FDA inspection practices and the most common deficiencies for medical device manufacturers including in vitro diagnostic device manufacturers. This presentation is further intended to help you prepare for and manage an FDA inspection in a proactive and effective manner. The top twenty (20) common deficiencies are based on the speaker’s analysis of 483s issued for the past seven (8) years.Areas Covered in the Session :Applicable Laws and RegulationFDA Manuals and Inspection GuidesHosting an FDA InspectionField Management DirectivesInspection Types and CategoriesInspection ClassificationFDA Forms 482 and 483Top Twenty (20) Most Common Deficiencies During FDA Inspections for Device ManufacturersHow to Identify Gaps between FDA Expectations and Firms’ Current Level of ComplianceWhat/How to Prepare for and Manage an FDA InspectionHow to Communicate Before, During and After inspection: Dos and Don’tsCommon Mistakes and How to Prevent ThemHow to Most Effectively Use Close Out MeetingResponding to 483s, If IssuedHow to Communicate with Emotional IntelligenceEmployee TrainingActual FDA Inspection Case Studies (Reports)Speaker’s PASS-IT Suggestions/RecommendationsConclusionWho Will Benefit:Quality AssuranceManufacturingRegulatory AffairsResearch & DevelopmentClinical AffairsSenior ManagementConsultantsContractorsCompliance OfficersAnyone Interested in the FDA InspectionPrice tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For more information and enquiries contact us atCompliance Trainings5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada  Customer Support : #416-915-4458 


19 Mar 2015 @ 01:00 pm

19 Mar 2015 @ 02:00 pm

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar

Organised by

Compliance Trainings (deactivated)

Premium Events in Science

Other Events in Science

Similar Webinars in Science

Recent Publications in Science

Recent Videos in Science

Recent Speakers in Science

Aleksandra Zivanovic
Social media manager


Paul Moss


Sri Krishnan
Keynote Speaker


Recent News in Science

📣New edition of ERC Magazine! This time we explore: 🔸scheme helping ERC grant applicants 🔸why researchers change c… https://t.co/ll9GnLBZ2l

@ERC_Research - 15 Jan 2021 13:59

ERC grantee Stylianos Choulis of @CyUniTech and his team explored new material and processing innovations that coul… https://t.co/br0qjwI71k

@ERC_Research - 15 Jan 2021 11:46

Support collaboration b/w ports of #Helsinki + #Tallinn via the #TWINPORT projects with over €51.5 m from… https://t.co/5QSnqBdPRi

@inea_eu - 15 Jan 2021 11:16

Premium EventsLearn more ..