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Manufacturing Quality Agreements- Qualifying Suppliers & Managing Quality in FDA-Regulated Industries
Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. In 2016, ...
- Intermediate
- 75 Mins
- Joy L. McElroy
- Dec 10, 2019
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
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
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