Health Canada 2015 - FDA Vs Health Canada
Date2015-06-10
Deadline2015-06-10
VenuePalo Alto, USA - United States
KeywordsElectronic business records tr; Compliant record management; E-records management program
Topics/Call fo Papers
This training program will elucidate the similarities and differences between the FDA and Health Canada promulgations of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.
Why Should You Attend:
For the life science industry, interaction with various regulatory agencies is a must. Successful interactions lead to first time approvals for licensure as well as minimum to no observations during inspections. Successful interactions lead to successful outcomes.
This webinar will be the first step in unraveling the keys to successful interactions with the US FDA and Health Canada officials. The training will discuss similarities and differences between the two agencies. Compliance in these areas have been shown to lead to successful FDA and Health Canada inspections and this course will explore cultural considerations that have been proved to be helpful.
Areas Covered in the Webinar:
Short History - FDA
Short History - Health Canada
Similarities between FDA and Health Canada
Differences between FDA and Health Canada
Cultural Considerations
Successful Interactions
Who Will Benefit:
Regulatory Affairs
Inspection Readiness/Preparedness
Sr. Directors/Directors
QA Specialists (Senior Level)
Compliance Professionals
Quality System Consultants
Instructor Profile:
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining quality management systems that are cohesive and properly interact with all areas of the organization.
During these 20 years, Ms. Dunston has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, she has worked with US FDA agents to ensure compliance for her clients.
Her international experience has assisted global organizations such as Johnson and Johnson, The Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has offered trainings on procedures from the V-suite to the manufacturing floor. Ms. Dunston works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
For Registration - http://www.complianceonline.com/fda-versus-health-...
Note: Use coupon code 232082 and get 10% off on registration.
Why Should You Attend:
For the life science industry, interaction with various regulatory agencies is a must. Successful interactions lead to first time approvals for licensure as well as minimum to no observations during inspections. Successful interactions lead to successful outcomes.
This webinar will be the first step in unraveling the keys to successful interactions with the US FDA and Health Canada officials. The training will discuss similarities and differences between the two agencies. Compliance in these areas have been shown to lead to successful FDA and Health Canada inspections and this course will explore cultural considerations that have been proved to be helpful.
Areas Covered in the Webinar:
Short History - FDA
Short History - Health Canada
Similarities between FDA and Health Canada
Differences between FDA and Health Canada
Cultural Considerations
Successful Interactions
Who Will Benefit:
Regulatory Affairs
Inspection Readiness/Preparedness
Sr. Directors/Directors
QA Specialists (Senior Level)
Compliance Professionals
Quality System Consultants
Instructor Profile:
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining quality management systems that are cohesive and properly interact with all areas of the organization.
During these 20 years, Ms. Dunston has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, she has worked with US FDA agents to ensure compliance for her clients.
Her international experience has assisted global organizations such as Johnson and Johnson, The Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has offered trainings on procedures from the V-suite to the manufacturing floor. Ms. Dunston works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
For Registration - http://www.complianceonline.com/fda-versus-health-...
Note: Use coupon code 232082 and get 10% off on registration.
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- Effective Strategy for Medical Device Recalls. - By Compliance Global Inc
- Best Practices for Quality Risk Management for the Pharmaceutical Industry. - By Compliance Global Inc
- Software Verification and Validation in Medical Industry - By Compliance Global Inc
Last modified: 2015-06-05 15:23:18