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Webinar On Medical Device Single Audit Program (MDSAP)

 
  January 16, 2015  
     
 


Compliance Trainings, Canada
2015-01-28


Description :

Every regulatory and quality professional working for a medical device company should attend this webinar to understand MDSAP objectives, MDSAP advantages and disadvantages and its implications for medical device companies.

The main goal of the MDSAP is to provide a more effective, efficient and less burdensome regulatory oversight of the quality management systems of medical device manufacturers. The implementation of the MDSAP is intended to allow for a single audit that will satisfy the regulatory requirements of FDA, TGA, Health Canada and Anvisa. 

 This webinar will provide valuable assistance to regulatory affairs and quality professionals working for or with medical device companies.

Areas Covered in the Session :

What is MDSAP

IMDRF Overview

MDSAP Objectives

MDSAP members

MDSAP Pilot Audit Process

MDSAP Advantages and Disadvantages

MDSAP implementation timelines

Who Will Benefit:

Professionals who will benefit from this training are in:

Senior Management

Middle Management

Manufacturing

Operations

Consultants

Quality Assurance

Regulatory Affairs

Documentation Department

Quality Auditors

Auditing Organizations

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

Suzan S. Davis is the President and CEO of Global Regulatory Partners-LLC that provides regulatory affairs, quality, safety and quality services to life science companies.

Suzan has 24 years of experience working in regulatory affairs and quality assurance assisting many biotech, pharmaceuticals and medical device companies such as Olympus, Smith and Nephew, Pfizer, EMD Sereno, Genzyme and GSK, register their medical devices in US and outside US and also implement and maintain their quality system properly.

During her career, Suzan prepared and submitted many 510(K), PMAs and design dossiers for CE marking. She has also conducted many ISO 13485 and quality system audits for multiple medical device companies in US, EU, Latam and Asia. She helped many medical device companies implement the appropriate quality systems and be in compliance with FDA and ISO 13485 requirements.

Suzan Davis has a Pharm.D from Pharmacy college in Paris, a Master in Regulatory Affairs and an MBA from Northeastern University in Boston. She is also a certified quality auditor by ASQ.

 
Deadline for Abstracts: 2015-01-28
 
Registration:

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1470

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

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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