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Webinar on FDA Foreign Inspections

 
  July 18, 2014  
     
 


Compliance Trainings, Canada
July 23, 2014


FDA’s applies U.S. regulatory requirements to foreign manufacturers during an inspection under strict time constraints. A successful inspection requires thorough preparation and practical logistics that can make or break the outcome. If you are not prepared, a failed inspection means that the FDA is likely to refuse the entry of the firm’s products. The webinar covers what FDA does and what you should do to prepare for an inspection, how you should manage the inspection as it takes place and what to do if you have problems. Firm’s that end up with inspectional observations or a Warning Letter have a lot of work to do in a very short time frame. The webinar will provide a “quick start” guide for what you should do to survive a regulatory disaster.

FDA’s import program has become complex and sophisticated. A successful import business requires a working knowledge of critical import requirements and what to do when a requirement is not met.

You will learn what the FDA regulatory hurdles are, how they work and how you can work with them in an efficient and effective way. You will also learn how the U.S. Customs and Border Patrol and FDA work in tandem.

Areas Covered in the Session :

How FDA prioritizes inspection assignments

How FDA prepares for inspections

A firm’s logistical preparation of an inspection

How to inter-act with the FDA on-site

How to respond to problems “observed” by FDA or a Warning Letter

How to manage import refusals and detentions

Who Will Benefit:

Foreign Manufacturers and Holding Companies

Initial Importers in the U.S.

Foreign Exporters

U.S. Initial Importers

U.S. Customs Import Brokers

International Regulatory Affairs Managers

Financial Planning Managers

Business Planning Executives

Business Acquisition Executives

Owners of New or Developing Import/Export Firms

International Trade Managers

Sales and Marketing Managers

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

 
 
Organized by: Compliance Trainings
Invited Speakers:

Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program. He is “of counsel” at Olsson Frank Weeda (OFWLAW) in Washington, DC and licensed to practice in Massachusetts and the District of Columbia.

 
Deadline for Abstracts: July 22, 2014
 
Registration:

For more enquiries contact us

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

To register this webinar visit

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

E-mail: suzzane.d@compliancetrainings.com
 
   
 
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