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Resume of CHL
Consultant
EXPERTISE AND SERVICES
Chemist, Biotechnology Consultant, Product and Process Validation Consultant, Quality Assurance Consultant, Accident Investigation, Accident Reconstruction, Specialist, Forensic Analysis, Investigation, Product Liability, Expert Witness Testimony, Consulting ServicesExpertise in pharmaceuticals and biotechnology consulting, quality assurance, quality control management, cGMP compliance, process validation, technology transfer, cleaning validation, particulate matter control and visual inspection, aseptic process design, facility and critical utility validation, HACCP, risk assessment, and organizational assessment.
This associate offers specific expertise relative to new facility start up, automated vial filling line, process validation audits, FDA compliance, analytical instrument validation, generic solid dosage manufacturing, modified release solid dosage, tablet and capsule manufacturing processes validation, process failure resolution, aseptic filling facilities, regulatory compliance, API cleaning validation, filtration process validation, analytical and microbiology laboratory audits, and new equipment integration.
Extensive knowledge regarding parenterals, sterile jellies, oral liquids, ointments sterile suspensions, HVAC Systems, environmental control systems, sterilization processes, clean in place, lyophilization, blow fill seal technology, barrier isolation technology, product sample analysis, raw material analysis, product stability, and API manufacturer audit
PRINCIPAL INDUSTRIES SERVED
Biotechnology, Chemistry, Manufacturing, Pharmaceuticals
EDUCATION
M.B.A., Clark University
M.S., Chemistry, University of Georgia
B.S., Chemistry, Georgia Tech
PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.
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Providing chemistry consulting, biotechnology consulting, product and process validation consulting, quality assurance consulting, and related expertise to a wide variety of clients.
Speak to this experienced, world-class expert now.
- Call (317) 735-7236
- E-mail chl@rapid-response-consulting.com
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Product Development, Process Validation Manufacturing Consultant
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Solid Dosage Form
Organizational Assessment evaluated the Product Development and Process Validation groups of a large generic solid dosage manufacturing organization in Canada in preparation to begin the development of generic drugs for sale in United States.
Process Validation Protocol Design (Modified Release Solid Dosage) Assisted a manufacture in the design of a validation program for the manufacturer of a Modified Release Capsule.
Organizational Assessment Analyzed the start-up plans (timeline and personnel requirements) for a new manufacturing facility in the United States.
Validation Report Design - Developed statistical procedures and report format for the validation of immediate release tablet and capsule manufacturing processes.
Technology Transfer Provided Technical guidance for the transfer and scale up of compressed tablet from one facility to another. This also included the investigation and resolution of a process failure.
Aseptic Processing
Technology Transfer (Lyophilized SVP) Managed the transfer of a lyophilized product from one third party manufacturer to a new manufacturer. This included the management of a cycle enhancement study. Designed and executed an experimental plan to evaluate a manufacturing problem with another dosage form manufactured by another third party manufacturer.
New Facility Validation (Blow-Fill-Seal) Managed the validation of a new facility for the aseptic manufacture of a sterile Blow-Fill-Seal product. This project included all Process Validation.
Aseptic Validation Program (LVP) Advising a manufacturer in the development and execution of an aseptic Validation program. This project included the preparation of the Aseptic Summary Report for the NDA submission.
Aseptic Facility Remodeling and Requalification (Lyophilized SVP) Advising a foreign manufacturer on the redesign and requalification of an aseptic filling facility.
Aseptic Facility and automated vial filling line - project timeline development and preparation of project validation Master plan.
Facility Validation Assessment Program Advised a Parenteral Manufacturer in the development and execution of a Validation Assessment Program to prepare the facility for a Pre-Approval Inspection.
Technology Transfer and Process Validation Audit Conducted an audit of the process development and process validation activities for the manufacture of an aseptically filled biological product and provided recommendations to insure compliance with applicable FDA guidelines and additional process controls.
Validation Program Restructuring Assisting a foreign manufacturer in the development of a sound validation program, assessing cGMP deficiencies, developing plans for the manufacture of Primary Stability Batches in support of an NDA, and preparation for a Pre-Approval Inspection by the FDA.
Particulate Matter Control Program Developed a program to reduce the particulate matter reject levels in small volume parenteral products and enhance the particulate matter inspection processes.
Eisai Inspection System Performance Qualification Developed Performance Qualification Protocols for Eisai EIS 596 Inspection System for the particulate and cosmetic inspection of solution containing vials and provided technical supervision during the execution. Prepared the Validation Summary Document, which was included in the Supplemental Application to the FDA.
Biotechnology, Quality Assurance, Validation Consultant
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Validation Training Program Developed and presented a tailored training program for engineers and technicians beginning a Product Validation program for the Bioprocess manufacture of an active pharmaceutical ingredient.
Quality Assurance Systems - Assisted a biotech firm in the development of quality assurance systems and provided external review of facility and Process Validation.
Master Plan for the Validation of Analytical Instruments - Developed a Master Plan for the validation of Analytical instruments used in the manufacture and control of biological products.
Position Paper on Filtration Developed a position paper in preparation of an FDA Pre-approval Inspection which defined the companies philosophy on the control and validation of various filtration processes.
Active Pharmaceutical Ingredients
API Cleaning Validation Program Advised an API manufacturer on the development of a cleaning validation program for a multi-product facility.
Cleaning Validation Master Plan Developed a cleaning validation master plan for the synthesis and purification systems for the solid phase manufacture of Olignucleotides.
Pre-Approval Inspection Readiness Audit Conducted audits of Analytical and Microbiology laboratories in preparation for a Pre-approval Inspection. The Inspection was completed without any 483 Observations.
Manufacturing Process Problem Resolution Assisted a manufacturer the identification of process improvements and the development of a series of experiments to verify process improvement.
Validation Management, Astra USA
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Managed the Validation function for a major parenteral manufacturer with experience including the start up of two new facilities, several facility renovations, numerous new equipment integration, and the transfer of twenty Generic products from the Product Development group into the manufacturing facilities. The dosage forms included parenterals, sterile jellies, oral liquids, ointments and sterile suspensions.
The breadth of validation experience has included such disciplines as: technology transfer, HVAC systems, environmental monitoring and control systems, sterilization processes, clean in place, aseptic processing, lyophilization, cleaning validation master plans, product validation master plans, facility validation master plans, particulate control, blow fill seal technology, barrier isolation technology.
Analytical Laboratory Management, Astra USA
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Has managed a Quality Control Analytical Laboratory that was responsible for the analysis of all bulk and finished product release samples, raw materials, product stability and complaint samples. The responsibilities of the laboratory included: laboratory investigation of out-of-spec results, problem investigation, method transfer, method development for product troubleshooting, qualification of secondary reference standards, auditing of API manufacturers.
Quality Assurance Manager, Norwich Pharmacal
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Managed the Quality Control and Quality Assurance functions for the manufacture of APIs, solid dosage forms and suspensions. Responsibilities included: all analytical and microbiological laboratory functions, internal audits, external audits, batch release, problem and deviation investigation, cGMP training.
PROFESSIONAL AFFILIATIONS
Parenteral Drug Association
International Society of Pharmaceutical Engineers
American Chemical Society
American Society for Quality
PUBLICATIONS
Numerous presentations on topics related to aseptic manufacturing validation maintenance, environmental monitoring and new facility validation, process simulation, operator intervention optimization, and author of article on aseptic pharmaceutical processes validation.
Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.
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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax