Search Trainings
Advertising and Promotional material compliance and review process
The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, stra ...
- Basic & Intermediate
- 90 Mins
- Peggy J.Berry
- Aug 21, 2019
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 ...
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
- Aug 27, 2019
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 ...
- Basic & Intermediate
- 90 Mins
- Susanne Manz
- Aug 28, 2019
FDA Compliance and Mobile Applications
We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system do ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Sep 03, 2019
Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Documentation - The Requirements
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivitive documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements currently being phased out and the new EU MDR Technica ...
- Intermediate
- 90 Mins
- John E. Lincoln
- Sep 10, 2019
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 ...
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
- Sep 10, 2019
Top Process Validation Mistakes - And How to Avoid Them
Validation is an important element of the Quality System Regulations and ISO13485.This course will cover the essentials of validation. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes.You’ll learn t ...
- Intermediate
- 90 Mins
- Susanne Manz
- Sep 11, 2019
How to Implement an Effective Human Error Reduction Program
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. For example; The CFR - Code of Federal Regulations Title 21 Subpart B_Organizat ...
- Basic & Advanced
- 90 Mins
- Ginette Collazo
- Sep 12, 2019
Using Kanban JIT Systems to Run a Startup Plant
Attend this webinar to learn how to set up and use kanbans, JIT, pull system, and drum-buffer-rope in medical device and biotechnology manufacturing start-up operations. Also, attendees will learn elements of lean documents and lean configuration, sterilizatio ...
- Basic & Intermediate
- 90 Mins
- José Mora
- Sep 12, 2019
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
This interactive webinar explains how to configure and validate a GxP compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ...
- Basic & Intermediate
- 75 Mins
- David Nettleton
- Sep 12, 2019