Search Trainings
Implementing the New Usability Engineering Standard – IEC 62366-1 and IEC/TR 62366-2: Guidance on Application
Part 1, IEC 62366-1:2015, “Application of the new Usability Engineering Standard to Medical Devices”, defines a 9-stage process to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety.This usability engineering (huma ...
- Intermediate
- 90 Mins
- John E. Lincoln
- May 22, 2019
Medical Device Software: Verification, Validation & Compliance
This course is essential for Medical Device companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for approval ...
- Basic & Advanced
- 60 Mins
- Nancy Knettell
- May 23, 2019
Knock, Knock, Who’s There? Preparing for an FDA Inspection
Are you ready for that knock on your door? Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage i ...
- Intermediate
- 90 Mins
- Susanne Manz
- May 30, 2019
Implementing a Robust Data Integrity Program
Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during co ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Jun 04, 2019
Technical Writing: A Detailed Process
Provides step-by-step instructions to produce excellent written presentations Learn how to balance between being precise enough to cover the subject matter yet general enough to apply to other locations and/or projects Learn how to deal with reviewers and ...
- Basic & Intermediate
- 60 Mins
- Robert Peoples
- Jun 04, 2019
Understanding Human Error in Manufacturing: Methodology for Investigations
As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of process deviations in manufacturing environments. Sadly, little is known about the nature of these events mainl ...
- Intermediate
- 90 Mins
- Ginette Collazo
- Jun 05, 2019
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
The various regulatory agencies have expectations that suppliers and vendors will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented w ...
- Basic & Intermediate
- 90 Mins
- Joy L. McElroy
- Jun 05, 2019
21 CFR Part 11 Conformance for Medical Devices
Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient sa ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
- Jun 06, 2019
FAA Drug and Alcohol Testing Requirements - How to Comply with Title 14 Code of Federal Regulations (CFR) part 120 and 49 CFR Part 40
This webinar will provide an emphasis on how to easily understand the FAA requirements relative to drug and alcohol testing and how to prepare for an FAA audit of an FAA approved Drug and Alcohol program. Federal Aviation Authority (FAA) regulations 14 CFR Pa ...
- Basic & Intermediate
- 60 Mins
- Mont Smith
- Jun 06, 2019
Effective Batch Record Review
In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a suitable reviewer of ...
- Intermediate
- 60 Mins
- Danielle Delucy
- Jun 11, 2019