Kenneth Christie
COO, VTS Consultants, Inc
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Prior to joining VTS, Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility in Rochester, MI. While there, he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. Additional responsibilities included routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.
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Recorded Webinar
Quality Assurance Requirements, Responsibilities and Expectations
This webinar first highlight the regulatory requirements of the quality system as found in both the US FDA regulations and those found in the Health Canada GMPs. The webinar will also examine the differences between Quality Assurance and Quality Control and the responsibilities of each. Quality System topics to be covered in addition to the regulatory requirements include personnel training, data integrity and quality expectations for laboratories, handling of deviations and OOS results, maintenance of an effective quality system through the establishment of CAPA and change control procedures and the importance of routine internal audits and audits of critical suppliers. Finally, the webinar will focus on the need to establish and adhere to procedures that address all of the topics listed above.
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Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production
This course will focus on three major points: The regulatory requirements for environmental monitoring, Main issues with environmental monitoring programs such as monitoring locations and the justifications for them, the types of sampling, and the establishment of operational limits, the handling of excursions and what are some of the common deficiencies cited by regulatory auditors.
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Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Learn more about FDA's current audit techniques and the most commonly cited GMP deficiencies that you have to watch out for. The webinar instructor, an FDA and GMP training expert, will help attendees analyse a system of risk assessments to determine audit frequencies.
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Good Documentation Practices: What Helps Make Your Controlled Documents Compliant
While there is no official requirement for "good documentation practices" it is a "current" industry practice that is reviewed and cited by federal regulators, corporate and third party auditors when audited. Since legal and controlled documents are subject to the recording of information and the signing and dating of such information by the person responsible, good documentation practices are expected to assure they are accurate, legible and traceable to name a few. It is well known that the FDA considers anything that is not properly documented to have never occurred, but how you document results is just as important. In addition, the lack of such good practices is routinely cited in FDA 483 observations, yet they should be some of the very first and basic topics covered during employee training.
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Supplier Qualification - Important Part of Quality Systems and Supply Chain Management
This webinar is important to the industry as all the regulations require quality assurance of the materials, components, and services that impact or are used for the final product configuration. In addition, supplier qualification is a critical portion of the quality system requirements (21 CFR 820), and companies must demonstrate control over their suppliers and the materials or services provided by them. This webinar will review the regulatory aspects of this program such as purchasing controls, evaluation of suppliers, contractors and consultants along with discussion of recent deficiencies found during their review by the inspectors.
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Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production
Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations when sampling methods yield positive results. Whether environmental monitoring is used simply to verify a state of cleanliness within a packaging area or during the production of sterile products, the assurance for sterility or area cleanliness is dependent not only on cleaning and sterilization methods used, but also with the control of the environment in which they are produced.
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Quality system requirements for cleaning, maintenance and calibration programs
This webinar is of importance to industry since the programs listed are some of the basic GMP expectations and found in many regulatory requirements. As a regulatory requirement, preventative maintenance, calibration and cleaning programs are what help assure that the validated state of equipment, utilities and systems remain in a state of control.
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How Best to Prepare to Host a Regulatory Audit
The term “audits” and what it implies, whether performed by regulatory auditors, internal audit teams or third party customers, often invokes both anxiety and questions as to how best to prepare for them. The more a company prepares for an audit, the more likely the results will be to their benefit.
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Validation Requirements for Sterile Products
The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few.
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Sterilization Processes: The Methods, Parameters and Deficiencies Often Cited
The sterilization of products or components is achieved through a variety of methods. This webinar will cover the common methods of sterilization, the terminology and the critical parameters associated with each. In addition, this webinar will also highlight recent deficiencies cited by the FDA regarding sterilization methods and their validation. This is a good basic course for those getting involved with performing and understanding sterilization cycles.
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The Basic Requirements for Developing IQ and OQ Protocols
Current regulatory requirements state the need to prove and document that equipment, systems and utilities are verified to perform their desired functions. This verification and documentation comes in the form of qualification protocols that verify proper installation, adequate support utilities, operation over its entire range, and acceptable performance according to established procedures and operational setpoints.
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FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies
In preparing for a regulatory audit, two very important sources of information to seek include knowing what the auditors will look for as areas of focus and what have been the most commonly cited drug GMP deficiencies. These items will help companies to better evaluate their own practices, address similar deficiencies that may have been found during internal audits and to prioritize their efforts so as to make sure they do not become another statistic of the top 10 most drug cited GMP deficiencies for 2012-2013.
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