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About JD Technologies

Jerry Dalfors is the JD behind JD Technologies. A sought after consultant, teacher and manager, Jerry is also known for his industry related presentations and published work.

Jerry's CV is listed below, and can be downloaded or printed in PDF and MS Word format.

JERRY DALFORS

Jerry Dalfors Summary of Industry Experience

Mr. Jerry Dalfors has extensive (40 years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages.  He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.   He has worked with or assisted more than two dozen companies with the establishment of controlled document/quality systems, FDA briefing and submittal documents, project management of several multimillion dollar  projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training.  Each of his projects have been received and accepted by the FDA and other regulatory agencies.  Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry.

Quality Management
His initial professional employment started as a Quality Control Technician and then moved to Quality Control management in the pharmaceutical industry which established his quality attitude which resulted in a multitude of successful technical and production operations as well as helping the FDA with inspector training (QSIT), sterilization and most recently related to the new PV Guidelines for collecting and conducting proper statistical tracking of process variables that may impact product quality.  His expertise in Quality has been used to re-engineer and remediate CAPA and Change Control programs at several major pharmaceutical companies to gain FDA approval along with helping clients avoid Warning Letters and Consent Decrees. Over is career he has helped train more than 100 FDA field inspectors regarding Quality Systems, Validation and Terminal Sterilization.

cGMP Application for Design and Operation
Having participated in helping FDA inspectors comprehend the initial GMP regulations (quality control, process control, laboratory testing, sterilization, etc) has given him the expertise to ensure that the Buildings and Facilities, Equipment Design, Cleaning and Maintenance, Room Classification and HVAC Design and Control are within the cGMP regulations during design or in an on-going basis.  QbD which is based on the FDA's Target Product Profile (TPP) regulations, has been the basis of his process design and validation activities prior to QbD becoming an common acronym used by the industry.  His format for Batch Records and Batch Record Review has become the industry standard to minimize operator errors and to maximize normal operation meets quality specifications.  His responsibilities in managing production operations has given him first hand experience needed to ensure each step of a process is not only documented in accordance with GDP, but also has been developed and defined to demonstrate consistent cGMP compliance.

Project Management
Shortly after his initial success as the site head of Quality Assurance Testing, the plant manager moved him into the engineering department to manage the instrumentation, process automation and validation activities.  Since then he has been requested into a multitude of project management scenarios which have included the start-up and validation of a multimillion dollar sterile filling and lyophilization facility, a multitude of process modifications or enhancements and/or FDA remediation as well as managing the start-up of three new pharmaceutical companies which included the facility and process design, FDA submissions, implication of Quality Systems and overall operation including staffing.

Process/Production Control and Instrument Calibration
Based on his quality foundation, positions responsible for developing cGMP compliant production and process control and along with necessary monitoring accuracy (instrument calibration including operations and testing laboratories) has given Jerry a very broad exposure to ensuring cost effective applications to not only meet quality requirements but to avoid high cost issues as result of mechanical failures which also includes preventative maintenance activities in a fashion that is synergistic with quality and profitability.  His contribution to the industry as seen by a number of FDA inspectors using the statistical tracking of the process is what the FDA came out with in the latest Process Validation Guidelines.  He helped write Stage 2 and 3 which also requires a good statistical comprehension.  He also well trained and experienced in process automation to properly identify the necessary elements and the needed sequence of operations in order to generate consistent, reliable and compliant automated process control.

Documentation, Record Review and Retention of Records
Having developed and maintained the current industry standards for BPR generation, effectivity to minimize operator errors and conduct Batch Record Reviews for FDA related consent decrees has given him a broad and extensive perspective for the generation of GDP SOPs as well as ensuring the documentation meets cGMP expectations while ensuring the components of the documentation process demonstrate without debate the product meets the approved product specifications.  The overall intent of documentation management is to ensure not only compliance but cost effective management of indirect costs associated with product release.

As result of this experience, he as served as the instructor for technical writing in several different applications (SOPs, Regulatory Documents, Validation Protocols, etc.)

Laboratory Controls
Having been the laboratory testing manager and having had to validate all the critical test methods, laboratory control and the associated LIMS applications to ensure Part 11 compliance is standard practice for Jerry

Validation
Jerry is one of the primary GURU's in the validation arena.  Having worked within the industry rather than being an outside contractor and having trained hundreds of FDA field inspectors has given him significantly better expertise for developing and managing validation requirements than most have today.  He has generated literally thousands of validation protocols for most every aspect of the pharmaceutical industry (facilities, utilities, equipment, processes and test methods) beginning with the end in mind - finish the project on time and under budget as well as defining what will be required for the ongoing PPQ protocol required for the new PV guidelines.  Also worked with Paul Motis with the FDA coming up with the very first electronic BPR which became Part 11.

Reprocessing and Rework
This has been a significant issue with the FDA relative to proper pre-definition and validation.  As result he has helped several companies define their reprocessing and rework activities to ensure proper or compliant activities that may affect product quality.

Customer Complaints
Monitoring complaints is a significant component of the Quality System and statistical monitoring of the process to identify variables that may be occur during the production process that may affect product performance.  Jerry has included this in the multiple annual report generation as well as deviation and CAPA systems to ensure a thorough perspective of identifying product quality variables to the Continuous Quality Improvement program is effective as well as CAPA effectiveness.

Regulatory Submissions
Jerry has generated a multitude of regulatory submissions as well as acting as the customer representative with the FDA for a number of projects.  Some companies do not allow contractors or individuals to have direct contact with the FDA, while others do.  In those situations, he has demonstrated a very effective working relationship with the FDA to make the approval process most efficient.  Jerry has never received a 483 observation on any of the work he has done in the industry and has helped many companies respond to their 483s without having a "non-acceptable" response.

Education and Training
B.S., Microbiology - Weber State College - 1969
MBA - 55 hours (incomplete MBA due to relocation to NC and could not transfer – only needed the thesis to finish)
Statistics (5 graduate courses with a focus on experimental design for proper statistical design of validation activities, quality control, quality assessments and clinical evaluations.
Process Control, Metrology (Electrical Technology and Instrument Calibration) and Automation (computer programming) as independent industry related courses

Corporate Positions
Quality Control Technician
Quality Assurance Manager.
Director Technical Operations
Validation Manager
Validation and Instrumentation Manager
Project Engineer and Qualification Manager
Process Engineer and Sterilization Manager
Senior Technical Specialist
Marketing Manager
Division Director and VP of Pharmaceutical Operations


Full Time Professional Experience

ALLIANCE PHARMACEUTICAL CORP. - SAN DIEGO, CA - 1988-1994

Title:     Div. Dir., Pharmaceutical Operations
Function:     Responsible for the construction, startup and operation of the Corporate Headquarters, two pilot facilities (with clean rooms and hot WFI Loops), Quality Control Laboratories and Vivarium.  Processes fully integrated using PC/PLC based automation and document generation.

Organized and set-up temporary manufacturing (clean room, filling and rotary terminal sterilization) facilities in Ireland and Germany to produce clinical materials for evaluation in Europe.

Responsible for the development and implementation of new methods, Quality Systems and procedures for manufacturing, sterilization and microbiological testing of unique new emulsion products and oral imaging agents.

Managed the equipment procurement and transfer of technical manufacturing operations to sister venture operation in Germany for European production, clinical evaluation and marketing.

Directed 5 departments (Pilot Operations, Microbiological Operations, Transfer Operations, Facility Operations and Validation Operations) with staffing of 30+ people and an annual operating budget in excess of $3 million.

CETUS - EMERYVILLE, CA - 1988

Title:          Manager, Validation within the Quality Unit
Function:   Responsible for establishing a validation department to support the new manufacturing facility as well as completing the validation efforts in a contractual arrangement with the design/build construction company.

Participated in the development of purification and cleaning procedures for the production of relatively complex fermentation products (IL-2 and TNF)

Provided direction for the compilation of the Functional Requirements for the fermentation process control systems (loops, alarms, data acquisition, etc.) which included production, CIP/SIP and waste sterilization.

Organized and directed efforts of multidisciplinary professionals including quality control, using in-house as well as outsourced resources, for the successful validation of the pilot plants and manufacturing facility.  A $1.5 million project that met all FDA inspections without a 483.

Successfully prepared and presented the Validation Master Plan and corresponding program to the FDA prior to completion of construction and assisted with the presentation of the construction plans.

KABI-VITRUM - CLAYTON, NC - 1984 - 1988

Title:          Validation/Instrumentation Manager and Director of Technical Services
Function:   Organized and directed the formation of the technical engineering group responsible for all process automation, evaluation of new equipment, validation and instrumentation.

Guided a vendor, production and electronics team through a total redesign and replacement of the control and documentation systems used for the critical sterilization of emulsion products.  Served as a major contributor in the design and construction of a new production facility which includes R&D laboratories, administration, utilities, shipping and receiving, etc.

Developed statistical models using experimental design methods to be used in place of 'traditional' methods often found to be inadequate in demonstrating appropriate probabilities of sterility assurance.

Prepared and maintained department budgets which included control of timelines and significant capital spending.

CUTTER LABORATORIES - OGDEN, UT and CLAYTON, NC - 1972 - 1984

Title:          Quality Assurance Testing Manager - (UT)
                  Project Engineer, Qualification - Validation (UT)
Instrumentation, Metrology Manager - (UT)
Process Engineer, Sterilization - Validation (NC)

As QC/QA Testing and Release Manager had the responsibility for managing the testing and final release of all incoming raw materials, final products (LVPs and Medical Devices) and environmental monitoring of the manufacturing facility.  Our laboratory was instrumental in ushering in the LAL testing for final product release and the participated in the industry forum establishing the particulate standards for parenteral solutions and medical devices.  Managed a staff of approximately 35.

Responsible for the establishment and organization of the industry’s first sterilization validation program (continuous sterilization of LVP’s) in conjunction with the instrumentation and biological monitoring of the process to arrive at the what later became known as the Process Fo – the correlation between the D-value of the spore and the temperature profile of the process.  Served as the lead member of a sterilization development program which later became an industry standard to be used by the FDA as a field training exercise for inspectors.  Developed and implemented the use of continuous monitoring of ETO concentration during the sterilization of medical devices

Designed the sterility testing process that has now become the industry standard initially marketed by Millipore.  Developed a variety of unique devices for monitoring temperatures, performing more accurate sterility tests, gathering and analyzing data, and implementing the applications at a highly practical level on the shop floor.

THIOKOL CHEMICAL CORP, BRIGHAM CITY, UT - 1968 – 1972 –  Quality Control technician verifying the quality attributes of solid rocket propellants including the initial Shuttle motors - Used CAPA before it entered the Pharmaceutical Industry and conducted the first cleaning validation for manually cleaned components.

Served as the lead member of a sterilization development program which later became an industry standard to be used by the FDA as a field training exercise for inspectors.
EDUCATION

B.S., Microbiology - Weber State College - 1969
Business Administration - 55 hours (incomplete MBA due to relocation to NC)
Extensive course work in;
Statistics, Process Control / Automation, Experimental Design and SQL
Variety of industry related short courses

FACULTY

Johnston Technical College, Smithfield, NC
Production Planning
Univ. Of California, San Diego (UCSD)
BioMedical Manufacturing Technology
Steering Committee, Engineering and Science - UCSD Extension

PUBLICATIONS

Terminal Sterilization of Perflourocarbon (PFC) Emulsions: Difficulties and Possible Solutions

"We Can Fix the Documentation Later", ISPE, 1999

PRESENTATIONS

Novel Sterilization of PFC Emulsions
PDA Annual Meeting - 1993
In-house versus Contract Manufacturing, BioTechnology Transfer Seminar
Biomanufacturing Issues in the University Cirriculum
Biotechnology Symposium - California State University - 8th Annual
Validation - Practical Strategies and Methodologies - 1996
Pharmaceutical & Biotechnology Contract Manufacturing - 1996
Mfg. Execution Systems (MES) - A Strategy for ISO-9000 Compliance
Western Manufacturing Automation Show - 1996
Validating BioPharmaceutical Utilities, IIR Conference - 2000
Organization and Management of Controlled Document Systems, Chairman, IIR Conference - 2000
Statistical Tools for Validation - IIR Conference 2001

MEMBER

Parenteral Drug Association (PDA)
International Society of Pharmaceutical Engineer (ISPE)
Instrument Society of America (ISA)

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