In his first ever podcast interview, Ken Christie, Chief Operating Officer of VTS Consultants, joins Heidi Schalk on the Business Growth Spotlight. With twenty years in aseptic manufacturing and twenty five years in consulting, Ken helps regulated manufacturers prepare for FDA inspections, respond to observations, and keep pace with expectations that rise as technology and equipment design evolve.

Ken shares why clients choose a consulting partner for honesty, a real understanding of their business, and a fair scope of work, and why he personally vets every consultant before they reach a client site. Drawing on more than 250 supplier audits worldwide, he explains how an audit reveals the truth about leadership commitment and how a company operates when the FDA isn’t at the door. His clearest sign of a healthy quality culture is leadership with manufacturing experience that thinks problems through instead of reaching for a quick fix. Quality, as Ken puts it, starts at the top.

About Ken:

EXPERIENCE:

1998 – Dec. 2025Chief Operating Officer

Directed company’s growth strategies, managed multiple client projects, assured client’s satisfaction of services and consultants placed on projects, along with acting as a material subject expert on the qualification of manufacturing equipment, utilities, processes, and sterile products produced through aseptic processing.

Routinely performed vendor/supplier and GxP quality system audits (GMP, GLP, ISO, tissue banks (AATB) and GCP), and evaluated regulatory compliance needs for clients. Provided senior level reviews of quality systems relating to pharmaceuticals, biotechnology, APIs, medical devices processes and cosmetics. Provides compliance direction for addressing regulatory issues associated with FDA 483 audit observations, CAPA investigations, warning letters and consent decrees. Accomplishments include working on consent decree remediation issues for aseptically produced products, assisting clients in Japan, Dubai, Spain, China, and India by addressing audit observations and corrective actions dealing with sterilization. Performs PAI’s (pre-approval inspections) against current standards as found in the FDA’s ‘Pre-Approval Inspection Compliance Program #7346.832. Performed over 250 supplier audits ranging from slaughterhouses, tissue banks, clinical trials to testing laboratories for verification of meeting cGMPs, ISO standards,  21 CFR regulations (210-211, 820, 1271, Part 11, etc.) and corporate expectations.

Seasoned industry speaker and trainer at professional conferences on a global basis on various cGMP issues along with being an “industry trainer” for various professional organizations such as ISPE, the Institute of International Research (IIR) in the US, IPA and AAPS of Canada and Shanghai NovoSciences. Topics covered include cGMPs for sterile products, Role of QA Professionals, Change Control, Environmental Monitoring and Quality Systems for Medical Devices to name a few. Author of several articles dealing with the Challenges of Aseptic Processing.

To connect with our guest, click on the links below:

LinkedIn:  https://www.linkedin.com/in/ken-christie-4980135/

Website:  www.vtsconsults.com 

Connect with me:

LinkedIn:  https://www.linkedin.com/in/heidischalkcoaching/

Website:  https://hlhgrowthsolutions.com  

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