While the idea of fewer inspections is a positive for industry – meaning less time will be spent with multiple regulatory agency inspections – each inspection now carries even more weight as it will be accepted by multiple agencies. Understanding both US Food & Drug Administration (FDA) and European Medicines Agency (EMA) GMP regulations is now more important than ever.
This course will be of benefit to anyone in the life sciences who is interested in 3-D printing as a method for developing a therapeutic product (e.g., medical device, drug delivery system, etc.), including those already using 3-D printing but want a better understanding of FDA’s position on the subject.
The purpose of this training is to present techniques and strategies for auditing computer systems validation documentation for compliance to applicable global regulations, plus internal policies and SOPs. Current issues including cloud systems and data integrity will be discussed.
In order to assure your firm’s data integrity, staff must be kept up-to-date on the handling of laboratory data/results – especially failing or out of specification (OOS) data. This webinar will cover the current expectations for handling OOS investigations – including the process, roles/responsibilities, and expected outcomes.
Don’t wait until an FDA inspection to learn there are deficiencies with your approach to drafting and implementing Quality Agreements! This course will provide an overview and discussion of significant portions of the guidance.
In this interactive webinar, we’ll explore a collection of conditions that can contribute to human error – including identifying the ONE condition where retraining may actually help.
This course looks at key design features and philosophies that will drive compliance to a successful conclusion. Additionally, this session will explore modern technologies of facility redevelopment that can extend the life of a facility by 10 -20 years, enhance compliance to current standards, reduce the operating risks, and provide more robust plant performance.
Most companies still show “human error” as a leading root cause to programs and issues in their organizations – even though it may not be the case. What if you could take some proactive steps at the organizational level that would address potential situations commonly seen as “human error” before they occurred?
Member of the Association for GxP Excellence (AGXPE)? Contact us to learn how you can save 25% on this course. DescriptionWho Should AttendWhat To ExpectDescription COURSE DESCRIPTION OVERVIEW In April 2016, the FDA issued its draft “Data Integrity and Compliance with cGMP Guidance for Industry.” This document quickly followed similar documents issued by other global [...]
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