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Live Webinar on FDA Adverse Event Reporting for Drugs and Medical Devices

 
  August 27, 2014  
     
 


Compliance Trainings, Canada
2014-09-25


This web seminar presents an overview of FDA’s Adverse Event Reporting Systems for Drugs and Medical Devices. Adverse Event Reporting for Investigational Drugs/Medical Devices and post-approval Adverse Event reporting will be covered. Attendees will receive information about FDA Adverse Event regulations and how to interpret and comply with the various regulations.

This is a must attend webinar for those personnel that require an understanding of the regulations governing  FDA’s Adverse Event Reporting for Drugs and Medical Devices.

Areas Covered in the Session :

FDA Adverse Event Reporting Systems

Investigational Adverse Event Reporting

Marketed Product Adverse Event Reporting

Adverse Reporting Definitions

Safety Reports and Unexpected Adverse Device Effects

Who Will Benefit:

Regulatory Affairs Personnel

Quality Personnel

Clinical Personnel

Research Personnel

Laboratory Personnel

Manufacturing Personnel

Legal Personnel

Auditors

Clinical Research Associates

Personnel who require a general understanding of the FDA’s  Drug and Medical Device Adverse Event Reporting requirements.

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:

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: 2014-09-25
 
Registration:

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

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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