clear

Please log in or sign up with

OR ENTER EMAIL
Please enter your email!
Please use valid email format!
Your email is too long.
clear

Some things are a mystery.
Would you like to sign up?

{{ email }}

Please enter your First Name!
Your First Name is too long.
No special Characters allowed!
Please enter your Last Name!
Your Last Name is too long.
No special Characters allowed!
Please create a password!
Password has to be at least 8 characters
Your Password is too long.
I agree to the Eventcombo Terms & Conditions
Please accept the Eventcombo Terms & Conditions
{{signupError}}
clear

Please enter the password for

{{ email }}

Please enter password!
{{loginError}}
Remember Me
clear

We sent an email to reset your password to

{{ email }}

Please enter password!
Password did not match.
clear

Please create a new password for

{{ email }}

Please create a password!
Password has to be at least 4 characters
Your Password is too long.
Please create a password!
Password has to be at least 4 characters
Your Password is too long.
Passwords did not match, please retype
clear

Congrats, you have a shiny new password!

clear

Congrats, you have successfully Registered!

{{LoadingMessage}}

clear
{{InfoMessage}}
clear

Error

Something went wrong. Please try again later

Sorry!

This event has been cancelled.

{{eventInfo.CheckoutText}} CheckOut {{eventInfo.CheckoutText}}

Ensuring Your Site is Ready for an FDA Inspection

{{selectedVenueName}} Select a different venue? {{venue.VenueName}}

location_on {{selectedVenue.Address}}
schedule {{eventInfo.EventDateTimeInfoString}} Select a different date? {{date.Description}}
{{eventInfo.PriceRange}}
favorite {{eventInfo.FavoriteCount}} thumb_up {{eventInfo.VoteCount}}

OVERVIEW

Although an effective Quality Management System should always be inspection ready, many medical device companies make basic mistakes during FDA inspections leading to 483s and even warning letters.  This webinar will help you create an inspection readiness plan, so you are well prepared for an FDA inspection.

WHY SHOULD YOU ATTEND

An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. But good preparation can ease the stresses and lead to much more favorable results. This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection.  If you’ve had a recall, an increase in MDRs, or it’s been more than 2 years since your last inspection, you can especially benefit from this webinar.

AREAS COVERED

•  FDA Inspection approach
•  Ensuring your site is ready for an FDA inspection
•  Inspection preparedness strategy and planning
•  Key roles during an inspection
•  SME (Subject Matter Expert) training
•  FDA audit preparation checklist
•  How to manage an FDA inspection
•  Common mistakes to avoid
•  How to respond to inspection observations

LEARNING OBJECTIVES

This webinar can help you manage inspections efficiently and effectively.  You’ll learn about the FDA’s inspectional approach, focus areas, and what documents they will be asking for.  A professional, polished, responsive approach sets a good tone for an inspection.  You will learn how to present information about your quality system in the most competent and professional manner.

WHO WILL BENEFIT

•  Quality Engineers
•  Compliance Specialists
•  Compliance Managers and Directors
•  Management Representative
•  Quality Managers and Directors
•  Business Leaders wishing to present a professional and compliant organization
•  Cross-functional leaders wanting to make sure their organizations are well prepared
•  Anyone involved with an FDA or NB inspection

SPEAKER

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.

Use Promo Code XMSNY19 and get flat 20% discount on all purchases.

To Register (or) for more details please click on this below link:

http://bit.ly/39xKBA7

Email: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

Speakers

{{speaker.SpeakerName}}
{{speaker.Title}}
{{speaker.Description}}

Sponsors

Frequently Asked Questions

{{faq.Question}} keyboard_arrow_right
View All

{{SocialPostFeed.SocialFeedTitle}}

#{{hashtag}}

replay
Reply
star
Retweet
star
Favorite
delete
Delete
Remove FEED from this event Remove FEED from all events
delete Delete Remove FEED from this event Remove FEED from all events
Training Doyens

Training Doyens

{{ i.title }}

{{eventInfo.TicketsTitle}} ({{eventInfo.RemainingTickets}} remain) Got Code?

Tickets are available for {{selectedVenue.VenueName}} on {{selectedDate.Description}}.
{{venue.VenueName}} {{date.Description}}
done

{{eventInfo.AccessPromoCode}}, code applied successfully.

close
{{ticket.TicketName}}
{{ticket.SourcePriceText}} {{ticket.TypeName}} (+{{ticket.FeeText}} FEE)
{{ticket.VenueName}} {{ticket.StartDateFormatted}} {{ticket.DateInfoString1}}
{{ticket.DateInfoString2}}

{{ticket.TicketDescription}}

This is a members-only ticket! Become a Member
{{item}} event_seat {{eventInfo.CheckoutText}}
Sold OUT
{{cartDealMap.dealoff}} {{cartDealMap.dealdetails}}
{{cartDealMap.dealdesbold}} {{cartDealMap.dealdessmall}}
thumb_up {{cartDealMap.dealthumbsup}}
Total: {{eventInfo.TotalPriceText}}

{{eventInfo.SaleCloseMessage}}

Bundle Your Order And Save ?

Buy together and save money! We have exclusive deals to make your event experience more convenient, cheaper and fun.

format_list_bulleted{{Dealbox.Text}} deals list

Teams

Teams are subsets of attendees who collaborate in the event with each other. Each team has its own members. When an event attendee purchases a ticket, they are not automatically added to a team; each attendee must join a specific team within an event.

{{member.BuyerName}}

Event Comments

clear

Share event with friends

Please enter friend's email.
Please use valid email format.
Your email is too long.
Please enter your message.
Your message is too long. Only 255 characters allowed.
clear

Send message to organizer

Please enter your email.
Please use valid email format.
Your email is too long.
Please enter your name.
Your Name is too long.
Please enter your message.
Your message is too long. Only 255 characters allowed.

{{LoadingMessage}}

clear
{{InfoMessage}}
clear

This is a members only event. If you are a new member, you will automatically be able to view this event if you are logged in.

clear

This is a private event, please enter event password

Please enter password!
{{privateLoginError}}
clear
Do you want to cancel your reserved ticket(s)?