By Amanda McFarland, M.Sc., Senior Consultant at ValSource, Inc.

Plot A Successful Course: Critical Risk Assessments With CDMOs – Amanda McFarland

By ValSource’s Marc Glogovsky & Paula Peacos

PDA Technical Report No. 88, written by ValSource’s Marc Glogovsky & Paula Peacos, along with other industry experts, presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the test, as opposed to providing methods for analysis of batch acceptability.

The distinct areas where microbial data is collected and inspected for deviation investigations are the focus of this document, including:

1) Roles and responsibilities of personnel, especially microbiologists, in the laboratory investigations and cross-functional teams responsible for manufacturing investigations,

2) Conducting laboratory investigations, and

3) Conducting manufacturing investigations.

The roles of other contributors to deviation investigations required for effective root cause analysis, such as representatives from manufacturing, process engineering, and quality assurance, are also briefly described.

This technical report promotes a lifecycle approach, but greater emphasis is placed on laboratory and manufacturing investigations of marketed drug products.

Full Technical Report available for download by February 13, 2022.

Guest Column Article by Tiffany Baker, Danica Brown, and Amanda McFarland of ValSource, Inc.

Guest Column Article by Tiffany Baker, Danica Brown, and Amanda McFarland of ValSource, Inc.

By John Weisgerber, ValSource Senior Project Manager

At ValSource, we only use certified labs to calibrate our test standards, adhering to NIST traceable standards. John Weisgerber, ValSource Senior Project Manager, outlines the key advantages of using an accredited lab for equipment calibration.

This is the 4th episode in our series focused on Advanced Therapeutic Medical Products (ATMPs) that includes cell and gene therapies. Specifically, we’ll be discussing ATMP/CGT and working with third parties. Providing their knowledge are 3 ValSource colleagues who have a wealth of experience: Ryan Murray, Steven Langille, and Darius Pillsbury.

You may select three officers and three board members who will take seats on the PDA Board of Directors. Vote soon, the election runs from Sept 7 – Nov 15. Vote for ValSource Senior Microbiology Consultant Marc Glogovsky for PDA Board of Directors!

By: Steve Langille

By Krunal Patel, ValSource Validation Consultant

The way we work has changed post-pandemic. With remote work and services on the rise, our team is beginning to assess the importance of electronic execution in CQV projects to plan for efficient delivery in the future. Krunal Patel, ValSource Validation Consultant, is applying lessons learned and current pain points to contribute toward development of a process that allows for electronic execution on CQV projects.

ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today proudly announced the hire of Jessica Chiaruttini, Ph.D. Jessica’s extensive FDA experience and diverse skill set brings added value to ValSource’s growing team of talent.