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132 results of "Life Sciences x" and "Clinical Research x"
Live Webinar

Mobile Medical Apps(is it a FDA regulated device) and Cyber Security

This webinar will explain how to determine if your app is a medical device and if it will be subject to FDA requirements.The FDA approval process for a new app will be explained including FDA requirements for software validation which are more extensive than j ...

Live Webinar

Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ

This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol ...

Live Webinar

How to Properly Investigate OOS Results

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and ...

Live Webinar

Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF)

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements.  Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdicti ...

Live Webinar

Human Error Reduction Techniques for Floor Supervisors

Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...

Live Webinar

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 ...

Live Webinar

Sponsor's responsibilities for an Active Investigational New Drug (IND)

This webinar will shed light on all the sponsor’s responsibilities for an Active Investigational New Drug application (IND). Alongside this presentation would detail each of the sponsor’s activity in greater detail including timelines to implement the same. Wh ...

Live Webinar

Adverse Event Reporting and Product Recalls

This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint hand ...

Live Webinar

Stability Studies and Estimating Shelf Life with Regression Models

Manufacturers of foods, drugs, consumer goods, and other products must determine the shelf life of their products so that customers know when the product can be expected to perform as intended. Many approaches are available to quantify the "shelf life" and the ...

Live Webinar

Supply Chain Security Procedures and Training to Support Customs and Trade Partnership Against Terrorism (C-TPAT) Compliance

The market for counterfeit and contraband, or “pirated” products can be divided into two important areas. The primary market provides consumers with counterfeit and contraband products. These consumers believe they have purchased genuine products. However, the ...