Webinar On Best Practices for 510(k) Drafting and Submission: Dos and Don'ts

From this webinar you will learn best practices for adequately putting your 510(k) together for your successful submission to the FDA, compliant with the FDA’s eCopy and RTA policy.

This session will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. 

David will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared. 

This session is a must for regulatory professionals working in medical device industry including those who are interested in the topic.

Areas Covered in the Session :

Statute(s) and regulations

Definitions

Device classification and how to identify predicates: key factors

510(k) program: when the requirement is of 510(K)

Regulatory requirements

510(k): requirements, contents and format

Substantial equivalence: special considerations

The task of addressing e-Copy and RTA policy requirements

Some of the common mistakes for RTA policy requirements

Applicable standards and guidance

Common pitfalls and how to prevent them: dos and don’ts

What to ensure while preparing for a 510(k) application

Response to FDA’s request of additional information

Resolving some of the different opinions and interpretations: dos and don’ts

Speaker’s practical, actionable and sustainable solutions (PASS)

Best Practices to achieve compliance and to stay compliant: dos and don’ts

PASS-IT suggestions and recommendations

Who Will Benefit:

Medical device quality and compliance professionals

Pharmaceutical compliance professionals

Quality

Regulatory affairs

CEOs

VPs

Attorneys

Clinical affairs

Research & Development

Consultants

Contractors/subcontractors

Anyone interested in the 510(K) matters

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 : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1354