home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops  
 

Webinar On 510(k) Preparation, Submission and Clearance: Dos and Don'ts

 
  May 11, 2015  
     
 


Compliance Trainings, Online
2015-05-18


Description :

FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program. 

This webinar will provide great opportunities to get familiar with how to best prepare for a 510(k) for a successful submission and clearance: in particular, recent trends including Dos and Don’ts. 

Based on speaker’s recent experience, he will discuss 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 presentation will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. 

In this presentation, the speaker 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 presentation is a must for regulatory professionals working in medical device industry including those who are interested in the topic.

Areas Covered in the Session :

Laws And Regulations

Definitions

Device Classification

Predicates

Recent FDA Final 510(k) Guidance

When a 510(k) Is Required

510(k) Requirements

Substantial Equivalence: Factors to Consider and Special Considerations

Addressing e-Copy And RTA Policy Requirements

Common Mistakes for eCopy and RTA Policy Requirements

Common 510(k) Pitfalls: How to Prevent Them: Dos and Don’ts

What to Ensure While Preparing for a 510(k) Application

Responding to FDA’s Request of Additional Information.

Resolving Different Opinions and Interpretations

Best Practices for 510(k) Contents and Format

PASS-IT Recommendations: Dos and Don’ts

 

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

 
 
Organized by: Compliance Trainings
Invited Speakers:

Speaker Profile

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

 
Deadline for Abstracts: 2015-05-18
 
Registration:

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1514

E-mail: suzzane.d@compliancetrainings.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.