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Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is effectively and clearly documenting procedures and work instructions that are easy to understand and execute. This article presents the requirements for documenting QMS procedures and work instructions, and then introduces methods to effectively and clearly do so.
This two-part article explores the use of various tools and the emergence of intelligent solutions in the industry.The first part provides an overview of how technological advancements and data analytics are critical in enabling regulators and the life sciences industry.
Who is ultimately responsible for quality/the quality management system at a life science company: (A) all personnel working for the company, (B) the quality assurance department, or (C) company management (including top executives)? Note your answer somewhere before reading this article.
Most manufacturing strategies today include some level of support from an outsourcing service provider such as a CMO or contract testing lab. There has been a great deal of discussion regarding the elevated role these providers play in the drug development process. Today’s CMO is likely to not only execute critical development activities but also provide insight based upon their own experiences with multiple processes.
The FDA guidance Medical Device Accessories – Describing Accessories and Classification Pathways, clarifies much of the confusion regarding accessory classifications, making now a good time to conduct a gap analysis to identify a thorough list of your current and future accessories, and to determine the guidance’s applicability to each.
Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process.
Thanks to our relationship with LSTI and an outstanding team here at Accelovance, we have built a training program that is able to be leveraged moving forward to address an industry need.
My main reason for taking the course was to re-evaluate quality agreements and how to improve our current template. Coming out of this, I would like to compare a few of our supplier quality agreements against the structure and checklist given in the course to see how they align.
Cook Pharmica LLC
All parts of the training were useful, including the topics of Documentation, Change Control and Revisions. I will now review our current Quality Agreement to make sure the requirements are included, and if not, add them.
I took the course to get a better understanding of FDA requirements. As an ISO 9001 registered organization, we need to control and cooperate with suppliers and this gave me some ideas on more formal ways to do that. The webinar was easy to attend with clear audio.