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Equipment Validation, Tracking, Calibration and Preventive Maintenance
Jeff Kasoff, RAC, CQM
Director Of Quality
Medivators
Friday, 4th September, 2015
01:00 PM EST | 10:00 AM PST
FDA’s General Controls for Medical Device Manufacturers
Sheila J. Ramerman, RAC
Founder
SJR Associates
Friday, 18th September, 2015
02:00 PM EST | 11:00 AM PST
FDA approvals of Orphan Drugs and Rare Diseases: An evolving competitive landscape
Lori B. Pereira
Founder & Principal
Spectra Health Solutions
Friday, 25th September, 2015
01:00 PM EST | 10:00 AM PST
Total Engagement - Ensuring that the Management Review Meeting is more than just a piece of paper
David Dabbs
Director of Quality Assurance
Quality BioResources
Friday, 2nd October, 2015
01:00 PM EDT | 10:00 AM PDT

FDA PMA Submissions – Contents, Process, Pitfalls
Sheila J. Ramerman, RAC
Founder

How FDA Trains Its Investigators to Review CAPA, and What You Can do to Prepare
Jeff Kasoff, RAC, CQM
Director Of Quality