New Seminars by ComplianceOnline - Sponsored posting

SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations: 2-day In-person Seminar - Cambridge, MA June 20/21

Computer System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar - San Francisco, CA  - June 20/21  and  Philadelphia, PA - Sept 26/27

The Sunshine Act - Have you seen the light? What you need to know to get prepared for August 1, 2013. The clock is ticking. Get prepared now, before it's too late! : One-day In-person Seminar - River North, IL June 21

Conducting Effective Investigation of Out-of-Specs and Atypical Laboratory Data: One and a Half day In-Person Seminar - Philadelphia, PA  July 11/12

A Comprehensive View of FDA Regulations for Medical Devices: 2 - Day In-Person Seminar - Boston, MA July 30/31 

Understanding and Implementing the Medical Device Directive: 2-Day In-person Seminar - Boston, MA Aug 1/2

Root Cause and Root Cause Analysis and Out-Of-Specification (OOS) Training: 2-day In-person Seminar - London, UK Aug 15/16

Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina): 2-day In-person Seminar - Philadelphia, PA Aug 22/23

GMP Compliance for Quality Control and Contract Laboratories: 2-day In-person Seminar - San Diego, CA Aug 26/27

Analytical Instrument Qualification and System Validation: 2- day In-person Seminar - Cambridge, MA Aug 29/30

Importing Medical device to US - Best Practices White Paper

The FDA does not recognize regulatory approvals obtained in other countries, therefore foreign firms that manufacture medical devices imported into the United States need to comply with applicable US regulations before doing so.

• Importers should ensure that they comply with the following:
• Establishment is registered with the FDA
• Devices have been listed with the agency
• Devices are manufactured in compliance with FDA's Quality System Regulations or QSR
• Adverse events related to medical devices are reported in a compliant manner
• Premarket Notification (510(k)) or Premarket Approval have been obtained from the FDA for any device to be imported into the US
• Foreign manufacturers should have a designated agent in the US.

In addition to FDA regulations, the importers must also comply with Customs and Border Patrol (CBP) requirements.

To get a detailed account of all regulations and best practices for medical device import download this free whitepaper on medical device import.

Also you can attend the seminar -FDA's Import Requirements and Managing the Import of FDA Regulated Products: 2-day In-person Seminar

Webinar Implementing GLP in Contracting Laboratories

It must be understood that in contract laboratories the GMP or GLP compliance lies with the study sponser, and hence it becomes necessary to know what are the roles and responsibilities of key Management, Supervisors, Scientists, Principal Investigators, Regulatory, QAU and other personnel in GLP facilities, contract laboratories.

Here are some webinars to refer.
http://www.gmptrainingsystems.com/files/u2/pdf/GLP_1.pdf
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=700870

webinar Related to Electronic Health Records (EHRs)

Using Electronic Health Records and Claims Databases for Rapid-Response Pharmacovigilance Studies

WEBINAR: ELECTRONIC HEALTH RECORDS SYSTEMS at $99
Leveraging EHR Stimulus Funding During Contract Negotiation