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FDA Guidelines for IoT (Internet of Things) Wireless Medical Devices
Samuel Santiago, PhD, MBA
Executive Director
Global Biotech Strategies
Friday, 6th May, 2016
01:00 PM EDT | 10:00 AM PDT
FDA PMA Submissions - Contents, Process, Pitfalls
Sheila J. Ramerman, RAC
Founder
SJR Associates
Thursday, 12th May, 2016
02:00 PM EST | 11:00 AM PST
What you need to know about FDA's de novo Process
Sheila J. Ramerman, RAC
Founder
SJR Associates
Friday, 13th May, 2016
02:00 PM EDT | 11:00 AM PDT
FDA approvals of Orphan Drugs and Rare Diseases: An evolving competitive landscape
Lori B. Pereira
Founder & Principal
Spectra Health Solutions
Friday, 20th May, 2016
01:00 PM EST | 10:00 AM PST
FDA and Medical Device Advertising in the 21st Century
J. Lawrence Stevens, RAC
FDA Regulatory Expert
Consultant, One Way Consultants, LLC
Friday, 20th May, 2016
01:00 PM EDT | 10:00 AM PDT
Biopharmaceutical Method Transfer – Using a Quality System Approach to Address FDA Method Transfer Concerns
Jeffrey Staecker, PhD.
Principal Consultant
BioPhia Consulting
Friday, 20th May, 2016
01:00 PM EDT | 10:00 AM PDT

Equipment Validation, Tracking, Calibration and Preventive Maintenance
Jeff Kasoff, RAC, CQM
Director Of Quality

How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare
Jeff Kasoff, RAC, CQM
Director Of Quality
No news available.