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Webinar On The FDA 510(k) and Q-Submission: Best Practices

 
  December 11, 2014  
     
 


Compliance Trainings, Online
2015-02-04


Description :

This webinar will provide an opportunity to get familiar with an FDA's process to communicate with the industry early in the process for sustainable 510(k) preparation and submission.

This webinar is intended to discuss how to put together a pre-submission (Q-submission) to obtain FDA feedback on your proposed questions, which will be helpful and useful for your device design, preclinical and clinical study plan and design, if applicable.

The speaker will discuss contents and format for a Q-submission and 510(k)compliant with the FDA's eCopy and RTA policy, helping you streamline your dialogue with the FDA for maximum benefits while preparing for a 510(k) submission in a least burdensome, effective manner.

In this webinar, 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 webinar 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 Predicates

510(k) Program

When 510(k)s Are Required

Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.

Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format

Substantial Equivalence: Factors to Consider and Special Considerations

Addressing e-Copy And RTA Policy Requirements

Applicable Standards and Guidance

510(k) Contents And Format

Common Pitfalls and How to Prevent Them

What to Ensure While Preparing Your Q-Submission and a 510(k) Application

Responding to FDA's Request of Additional Information.

Resolving Different Opinions and Interpretations

Best Practices for a Q-submission

Best Practices for a 510(k) Preparation, Submission and Clearance

Speaker's Practical, Actionable and Sustainable Solutions

Conclusions

Who Will Benefit:

Regulatory Affairs

Research & Development

Quality Assurance

Quality Control

Quality System Management

CROs

Consultants

Contractors/Subcontractors

Senior management

Anyone interested in 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

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1358

 
 
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: 2015-02-04
 
Registration:

 

https://compliancetrainings.com/siteengine/Login.aspx 

E-mail: suzzane.d@compliancetrainings.com; uttam@compliancetrainings.com
 
   
 
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