What is the process of registering with 247compliance.com webinars?

You can register for our events and webinars through a simple registration process. Choose a program of your choice and fill in a simple, hassle-free registration form to get started.

Is there an option of purchasing a recorded webinar?

Yes. Besides purchase of live webinar sessions, you can also make a purchase of recorded webinars.

What is the payment methodology for 247compliance.com?

247compliance.com accepts all modes of payment – MasterCard, Visa and American Express credit/debit cards.

How secure is my online transaction with 247compliance.com?

Your online transactions with us are extremely secure. We operate on a safe and reliable platform and hence your data is safeguarded from misuse, unauthorized disclosure or access, destruction, modification or loss.

A webinar is a live meeting that takes place over the web. The meeting can be a presentation, discussion, demonstration, or instructional session. Participants can view documents and applications via their computers, while shared audio allows for presentation and discussion.

What is a recorded session?

Recorded audio and video of a WebEx session alone with presentation where the speaker explains his area of expertise (Note: This does not include the live session)

How long does an average webinar span?

The duration of an average webinar extends anywhere between 60 minutes to 90 minutes.

How do I receive confirmation of my registration?

Upon registration, you will receive confirmation intimation through email. At the end of the registration process, we will send you an invoice letter.

Software Validation for the New FDA Inspections

By: Edwin Waldbusser

Recorded Session

Duration
60 Minutes

Training Level
Intermediate to Advanced

Email Reminder

Transcript

($179) - Transcript

Recorded Session

($239) - Downloadable Session

Training CD

($350) - Training CD

For multiple location please contact our customer care team
Contact: +1-661-336-9555.

Webinar Details

The imperative aspect of Software Validation is the backbone of the software industry that deals with software authenticity, efficiency, and removes any invalidated bug that might risk the endurance of your software. This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis invalidation. How software requirements are used in validation will be described. This course is not a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

WHY SHOULD YOU ATTEND?

Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements, analyses, and tests that the FDA feels are necessary to prevent user injuries. These requirements were developed after analysis by the FDA of many recalled medical devices. In this webinar, you will learn the requirements in addition to functional tests that are required to produce a validated software product.

AREA COVERED

Software Validation more than testing
Requirements traceability
Risk analysis
Unit, Integration, and System testing
Algorithm validation
Challenges to the software
Configuration management

LEARNING OBJECTIVES

In this webinar you will learn the requirements in addition to functional tests that are required to produce a validated software product, also this webinar will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product.

WHO WILL BENEFIT?

Engineer
Engineer Management
Software Engineer
Programmer
Quality Assurance
Regulatory

Software Validation more than testing
Requirements traceability
Risk analysis
Unit, Integration, and System testing
Algorithm validation
Challenges to the software
Configuration management

Engineer
Engineer Management
Software Engineer
Programmer
Quality Assurance
Regulatory

SPEAKER PROFILE

Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.