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Webinar On The FDA Medical Device Approval Process: Preparation of 510(k)s, IDEs, PMAs

 
  December 11, 2014  
     
 


Compliance Trainings, Canada
2015-02-05


Description :

This web presentation presents an overview of the requirement to obtain FDA permission to market a Medical Device products.

We will discuss the regulatory requirements and the various FDA submissions, the 4 types of 510(k)s and the contents of each. We will also discuss the contents and requirements for IDEs and PMAs, guidelines for each aspect of research are provided, as well as information on the structuring of submissions and post-approval documents. Attendees will get a better understanding of the FDA Medical Device Approval Process and the underlying scientific and regulatory principles involved. The course enables regulatory affairs professionals to provide the FDA with necessary information and obtain product approval.

Areas Covered in the Session :

Navigate the FDA medical device approval system

Preparing contents of the 4 types of 510(k)s

Preparing contents of an IDE

Preparing contents of a PMA

Non-significant risk devices

Significant risk devices

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Manufacturing Personnel

Auditors

Legal Personnel

Personnel who require an understanding of the FDA Medical Device Approval Process

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=MD1405

 
 
Organized by: Compliance Trainings
Invited Speakers:

Speaker Profile

Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements.

 
Deadline for Abstracts: 2015-02-05
 
Registration:

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

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