Kenneth Christie
Kenneth Christie
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, APIs 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.
Mr. Christie was the Validation Manager at Parke-Davis’ Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had 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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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... -
Current Regulatory Requirements for Aseptically Produced Products
The manufacture of sterile products, whether by aseptic means or terminal sterilization, requires a thorough understanding of applicable regulations by the FDA and those by the EU if selling your products overseas. In addition, there are various guidance documents... -
Regulatory Expectations for Environmental Monitoring Programs
Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing... -
Requirements for IQ, OQ and PQ Quality Protocols
Current regulatory requirements state the need to prove equipment, systems and utilities are verified to perform their desired functions. This verification comes in the form of qualification protocols that verify proper installation, operation over its entire range, and acceptable... -
Internal Audit – How Best to Perform Them
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... -
Sale!
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Sterilization Processes – The Methods, Parameters and Deficiencies
The sterilization of products or components is achieved through a variety of methods. This webinar will cover the common methods of sterilization such as saturated steam, radiation, dry heat, ethylene oxide, the terminology and the critical parameters associated with... -
Effective Change Control Program – Challenges and Regulatory Requirements
This webinar will provide the attendees with a better understanding of the importance of a change control procedure, what areas inspectors tend to look for during an audit and the challenges that change control programs present to companies in... -
Sale!
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Sale!
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Sale!
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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... -
Good Documentation Practices – What Helps Make Your Controlled Documents Compliant
Officially there is no requirements as per the FDA and other regulatory bodies for “good documentation practices”, however, it is a “current” industry practice and if often reviewed and cited by auditors during audits. All legal and controlled documents... -
Basic Requirements for IQ, OQ and PQ Quality Protocols
Current regulatory requirements state the need to prove equipment, systems and utilities are verified to perform their desired functions. This verification comes in the form of qualification protocols that verify proper installation, operation over its entire range, and acceptable... -
FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
A successful audit is dependent on understanding what we could expect from regulators. This can be observed by looking at the focus of recent inspections within the industry. Such case studies will help companies to analyze their own practice... -
How to be Well Prepared 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... -
Sale!
Effective Change Control Program – Challenges and Regulatory Requirements
This webinar will provide the attendees with a better understanding of the importance of a change control procedure, what areas inspectors tend to look for during an audit and the challenges that change control programs present to companies in... -
How to be Well Prepared 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... -
The Good, the Bad and the Ugly Aspects of Change Control. Which One Describes Your Company’s Program?
This webinar will provide the attendees with a better understanding of the importance of a change control procedure, what areas inspectors tend to look for during an audit and the challenges that change control programs present to companies in... -
Sterilization Processes: The Methods, Parameters and Deficiencies
The sterilization of products or components is achieved through a variety of methods. This webinar will cover the common methods of sterilization such as saturated steam, radiation, dry heat, ethylene oxide, the terminology and the critical parameters associated with... -
FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
The success of an audit by federal regulators does not always depend on the level of training provided to staff and department employees, but also in understanding the focus of recent inspections within the industry. Such information provides a... -
Regulatory Expectations for Environmental Monitoring Programs
Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing... -
Regulatory Expectations for Environmental Monitoring Programs
Description: Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when... -
The Good, the Bad and the Ugly Aspects of Change Control. Which One Describes Your Company’s Program?
Description: This webinar will provide the attendees with a better understanding of the importance of a change control procedure, what areas inspectors tend to look for during an audit and the challenges that change control programs present to companies... -
Sterilization Processes: The Methods, Parameters and Deficiencies
Description: The sterilization of products or components is achieved through a variety of methods. This webinar will cover the common methods of sterilization such as saturated steam, radiation, dry heat, ethylene oxide, the terminology and the critical parameters associated... -
FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Description: The success of an audit by federal regulators does not always depend on the level of training provided to staff and department employees, but also in understanding the focus of recent inspections within the industry. Such information provides... -
FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Description: The success of an audit by federal regulators does not always depend on the level of training provided to staff and department employees, but also in understanding the focus of recent inspections within the industry. Such information provides... -
Sterilization Processes: The Methods, Parameters and Deficiencies
Description: The sterilization of products or components is achieved through a variety of methods. This webinar will cover the common methods of sterilization such as saturated steam, radiation, dry heat, ethylene oxide, the terminology and the critical parameters associated... -
The Good, the Bad and the Ugly Aspects of Change Control. Which One Describes Your Company’s Program?
Description: This webinar will provide the attendees with a better understanding of the importance of a change control procedure, what areas inspectors tend to look for during an audit and the challenges that change control programs present to companies... -
Regulatory Expectations for Environmental Monitoring Programs
Description: Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when...