Expert Connection

For senior executives who want a deep dive into all things quality.

Title Format Length Faculty Description
Quality Systems Training for Devicemakers - Module 9 eLearning 8 hours Christine Nelson CDRH trainer Christine Nelson explains CAPA requirements of Part 820. Includes quiz.
Secrets of Medical Device Complaint Management Video 3 hours Dan O'Leary In-depth look at complaint management requirements and how they impact other systems.
Quality Systems Training for Devicemakers - Module 8 eLearning 8 hours Christine Nelson CDRH trainer Christine Nelson explains compolaint management requirements of Part 820. Includes quiz.
The Auditable Complaint File Video - MDQC 2015 47 minutes Connie Hoy 2015 MDQC video
Writing a Flawless 483 Response eLearning 10-minutes John Avellanet How to respond effectively to a 483 within the 15-day deadline.
Face to Face with FDA Investigators Video 2.25 hours Lori Lawless et al Lori Lawless explains investigators' training and inspection processes and leads panel of current and former FDA investigators in answering attendees' questions.
Inspection Preparation Training for Drugmakers Video 2.5 hours Fred Branding Guide to building an inspection preperation plan.
Secrets of QSIT-based Medical Device Inspection Preparation Video 3 hours Tim Wells Coaches devicemakers at all levels on how to understand QSIT and use its ever-changing nuances to pass their next inspection.
Best Practices in FDA 483 and Warning Letter Management Video - Inspection 2014 1.25 hours Elaine Messa 2014 Inspections Summit presentation.
Effective Management of Front and Back Inspection Rooms Video-Inspection  2015 1.5 hours Julie Larsen et al 2015 Inspections Summit presentation.
Flawless FDA Inspection Handling and Response Video-Inspection  2015 3 hours John Avellanet Inspection Summit 2015: Preconference workshop; 3 parts
Data Analysis Techniques for Device Manufacturers Video-Inspection  2015 3.25 hours Dan O'Leary Inspection Summit 2015: Preconference workshop; 2 parts
Quality Systems Training for Devicemakers Module 4 - Design Control eLearning 8 hours Christine Nelson FDA-produced training session on design control. Includes quizzes.
Quality Systems Training for Devicemakers Module 5 - Material Control eLearning 8 hours Christine Nelson FDA-produced training session on material control. Includes quizzes.
Quality Systems Training for Devicemakers Module 6 - Production and Process Control eLearning 8 hours Christine Nelson FDA-produced training session on production and process control. Includes quizzes.
GMP Training for Drugmakers Video 4 hours Seth Mailhot Introduction to the 10 sections of Part 211 and what each means. Video segmented by section.
Quality Systems Training for Devicemakers - Introduction eLearning 8 hours Christine Nelson FDA-produced training session on general quality system requirements. Includes quizzes.
Quality Systems Training for Devicemakers - Scope and Management eLearning 8 hours Christine Nelson FDA-produced training session on building and managing a quality system. Includes quizzes.
Recall Management for Devicemakers eLearning 10-minutes Pamela Forrest Explains key concepts in recall management, including clarifying conflicting regs, and when/how to report to the FDA. Includes quiz.
Quality Systems Training for Devicemakers Module 3 - Documents, Records and Change Control eLearning 8 hours Christine Nelson FDA-produced training session on documentation and recordkeeping. Includes quizzes.
Data Integrity: Is Complacency Putting You at Risk Video-Inspection  2015 1.5 hours Vicky Stoakes et al 2015 Inspections Summit panel presentation.
Insider's Guide to Supplier Quality Success Video 6 hours Martin Browning Instruction on making sure your suppliers meet the same quality standards the FDA expects of you. Emphasis on the FDA’s current inspection trends. 
Secrets of Successful Quality Agreements Video 3 hours Steve Scharf and William Reiss How to build a supplier quality agreement and the 24 elements it should contain.
Quality Systems Training for Devicemakers Module 7 - Process Validation eLearning 8 hours Christine Nelson FDA-produced training session on validating processes. Includes quizzes.
Combination Products Video-Inspection  2015 53 minutes Elaine Messa 2015 Inspections Summit presentation explaining FDA's new approach to combo products.
Quality Systems Training for Devicemakers Module 10 - FDA Certificates eLearning 8 hours Christine Nelson FDA-produced training session on requirements for export certificates. Includes quizzes.
Cautionary Tales Video-Inspection  2015 38 minutes Vicky Stoakes 2015 Inspections Summit presentation on real-world examples of GMP deficiencies.
A Day in the Life of FDA Field Investigators Video-Inspection  2015 1.5 hours Steve Niedelman et al 2015 Inspections Summit panel presentation of current and former FDA investigators discussing how they work.
Former Investigators Tell All: 10 Best and Worst Things to Do Video-Inspection  2015 1.5 hours Steve Niedelman et al 2015 Inspections Summit presentation.
How to Assure Your Seven Subsystems are in Compliance and Linked Together Video - Inspection 2014 48 minutes Lori Lawless  2014 Inspections Summit presentation on how devicemakers should  structure their quality systems.

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