Distributors may purchase multiple copies of packages to distribute to learners, and follow their progress. Bulk discounts are below.
| Quantity | Price per voucher |
|---|---|
| 1+ | $0.00 |
| Q&A Session Schedule |
| Q&A |
| Chapter 1: Introduction |
| Introduction by Maria Oyaski | ||
| Regulatory Authority Meetings by Kevin Barber | ||
| CMC/Quality System Design & Development by Scott Burian |
| Chapter 2: Early Development |
| Good Laboratory Practice by Brenda Faiola | ||
| Good Clinical Practice by David Jensen | ||
| Clinical Protocols and Clinical Development Plans by Nicholas Kenny, Jack Modell, Ben Vaughn | ||
| Combination Product Overview by Judy Hauser |
| Chapter 3: Regulatory Procedures |
| Investigational Device Applications by David Jensen | ||
| 510(k)_PMA_Canada_EU_International by Ken Butz | ||
| Medical Device Special Programs by Kevin Barber |
| Chapter 4: Specific Product Types |
| Device Classification by Maria Oyaski | ||
| MedicalDevice_DesignProcess_DesignControls by Cheng Li | ||
| In-vitro Diagnostic Reguations by Maria Oyaski | ||
| Medical Device Software by Sheila Hemeon-Heyer (2020) |
| Chapter 5: Late Development |
| Pharmacovigilance and Risk Management by Lisa Hornick | ||
| Prescription Product Labeling by Theresa Scocco and Joseph Watson | ||
| Compliance_Inspections_Enforcement by Drew Barlow | ||
| Post Marketing by Karin McIntosh |