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Webinar On The 510(k) Program: Substantial Equivalence In Premarket Notifications

Education

(Free Press Release) This webinar is a must for those personnel that require an understanding of the FDA's 510(k) substantial equivalence determinations.

Webinar On The 510(k) Program: Substantial Equivalence In Premarket Notifications


      

This guidance was released on July 28, 2014. FDA developed this document to provide guidance about current review practices for premarket notifications (510(k)) submissions. FDA's intent is to identify, explain and clarify each of the critical decision points in the decision making process FDA uses to determine substantial equivalence. The intent of this document is to enhance the predictability, consistency and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies and practices underlying FDA's 510(k) review process.

This webinar is a must for those personnel that require an understanding of the FDA's 510(k) substantial equivalence determinations.

Areas Covered in the Session :

510(k) Regulatory Framework

510(k) Policies

510(k) Practices

510(k) Critical Decision Points for Substantial Equivalence

 

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Laboratory Personnel

Manufacturing Personnel

Legal Personnel

Clinical Research Associates

Personnel who require a general understanding of the FDA's 510(k) program for determining substantial equivalence

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada

Customer Support : #416-915-4458

Email : This e-mail address is being protected from spambots. You need JavaScript enabled to view it

For more information about this event please visit

 

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1229




Webinar On The 510(k) Program: Substantial Equivalence In Premarket Notifications

Source: Press Release

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