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189 results of "Life Sciences x" and "FDA Compliance x"
Live Webinar

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 ...

Live Webinar

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 ...

Live Webinar

Onboarding New or Transferred Employees in a GMP Environment

The objective of the course is to enable attendees to: Define the onboarding process in the context of regulatory compliance Interact with Human Resources to create a coordinated onboarding strategy that covers both their requirements and quality requireme ...

Live Webinar

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 ...

Live Webinar

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 ...

Live Webinar

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 ...

Live Webinar

FDA Case Scenarios – Best Practices for Managing Inspection Situations

Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard to manage properly. In this webinar, you will hear about real li ...

Live Webinar

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 ...

Live Webinar

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 ...

Live Webinar

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 ...