Search Trainings
How to Write Sop'S that Avoid Human Error
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...
- Advanced
- 90 Mins
- Ginette Collazo
- Dec 11, 2019
Most Common Problems in Computer System Validation (CSV) and Compliance
This seminar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.This is critical in order to develop the appropri ...
- Intermediate
- 90 Mins
- Carolyn Troiano
- Dec 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
- Dec 12, 2019
MDSAP - How To Implement MDSAP - Requirements Into Your ISO 13485 Quality Management System?
This course will give an introduction into the Medical Device Single Audit Program (MDSAP). The introduction will give an overview of the program definition, the requirements for the quality management systems defined by the member states of this program (Aust ...
- Intermediate
- 90 Mins
- Dr. Dr. h.c. Fr
- Dec 12, 2019
Risk Management - Principles of Lean Documents and Lean Configuration
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device. During all phases of a project, any new consid ...
- Basic & Intermediate
- 90 Mins
- José Mora
- Dec 18, 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
- Jan 08, 2020
Non-conforming Material and Failure Investigations
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material.You’ll learn where non-conforming material can occur and ...
- Intermediate
- 90 Mins
- Susanne Manz
- Jan 09, 2020
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
- Jan 09, 2020
Avoiding Death by CAPA – What you need to know
CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. ...
- Basic & Advanced
- 90 Mins
- Susanne Manz
- Jan 13, 2020
Validation Master Plan - Written and Unwritten Requirements
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Validation Master Plan, evaluating its elements ag ...
- Intermediate
- 90 Mins
- John E. Lincoln
- Jan 15, 2020