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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
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
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
Cannabinoids as Drugs
This webinar will discuss the current status of cannabinoids as medical products in the United States. The focus will be on what we can learn from the FDA approval of Epidolex (Cannabidiol) oral solution 100 mg/mL. How to obtain research information will be pr ...
- Basic & Intermediate
- 90 Mins
- Loren Gelber
- 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
Post marketing responsibilities for pharmacovigilance in the European Union (EU)
There is comprehensive regulation around the safety of medicines in the EU and marketing authorization holders have extensive responsibilities in this area for the drugs they market. The presentation will provide information on the requirements for pharmacov ...
- Intermediate
- 90 Mins
- Janet Jepras
- Jun 18, 2019
Good Documentation Practices (GDPs) for FDA-Regulated Computer Systems
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s C ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Jun 19, 2019
Device Changes and the 510(k) – Hardware and Software
This webinar will evaluate two recently published U.S. FDA Guidance Documents on device changes: 1) “Deciding When to Submit a 510(k) for a Change to an Existing Device Final Guidance for Industry and FDA Staff”; and 2) “Deciding When to Submit a 510(k) for a ...
- Intermediate
- 90 Mins
- John E. Lincoln
- Jun 19, 2019
Practical Implementation of Pharmaceutical Quality Risk Management (QRM)
Recognize the purpose and value of Quality Risk Management (QRM), as well as how it applies to your job Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions Identify key QRM terminolog ...
- Basic & Intermediate
- 60 Mins
- Steven Laurenz
- Jun 19, 2019