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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
Allergen Cleaning, Validation & Preventative Risk Management
A three-layered approach to Allergen Management will be described, with the latest approaches for cleaning, Validation, monitoring and Preventative Controls now required under FSMA (Food Safety Modernization Act) to incorporate in your Food Safety Plan. Insigh ...
- Basic & Intermediate
- 60 Mins
- Gina Reo
- 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
Impact of Manufactured Proteins on the Food Supply Chain: Consumer, Manufacturing, Environmental, Market and Cost Changes
The world is changing. The way we eat is changing. The trend towards meatless “meat” products is just beginning. Along with this new trend are arguments about health, safety, consumer acceptance and many environmental issues focused on critical environmenta ...
- Basic & Intermediate
- 60 Mins
- John Ryan
- 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
FDA Regulations for Pharmaceutical Current Good Manufacturing Practices
This webinar will review all the sections of FDA cGMP regulations. Regulation text and examples from the instructor’s experience will be presented. Warning Letters and Inspectional Observations will be used as examples of what not to do.
- Basic
- 90 Mins
- Loren Gelber
- 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
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. Metrics for numerous departmental functional areas will be discussed; incl ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
- Dec 19, 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
Corrective and Preventive Action - Your Most Important Process
While ISO 9001:2015 assigns corrective and preventive action to clauses 8.7 and 6.1 respectively, the same process can handle both activities and support other ISO requirements such as the organizational knowledge data base. It can also be extended to exploit ...
- Intermediate
- 75 Mins
- William A. Levi
- Jan 08, 2020