James Begani
President

Jim, a graduate of Clarkson University, has over 20 years industrial cGMP experience, ranging from manufacturing of active pharmaceuticals ingredients, parenteral production to biopharmaceutical application. He is experienced in chemical and bioprocess development and optimization; pilot plant operations; clinical material manufacturing; and biopharmaceutical fermentation and purification. Jim has been involved in all phases of the cGMP process; utility and facility design; commissioning; qualification and validation; and certification. His specific involvement in the above area included process definition; facility layout and planning; design and specification review; construction quality control, and validation planning. He has reviewed and designed vaccine downstream processes, aseptic fill facilities, and equipment to improve efficiency and provide for sterile processing.


Jim also has vast experience in the generation of cGMP document for both equipment and utilities, including qualification protocols, SOPs and reports. He possesses a comprehensive understanding of designing and implanting facility operation plans that comply with FDA, UK and EU regulations.
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Sandra Dixon
Director of Quality

A graduate of the University of Kansas, Sandra holds a Bachelor of Art in Microbiology.  She has over 20 years experience with Quality Assurance, Quality Control, Manufacturing and Regulatory Affairs for human and veterinary pharmaceuticals, biologics, vaccines, solid/oral dosage forms and food science.  She has a proven track record of interfacing with regulatory agencies serving as the primary coordinator for FDA and Health Canada inspections and has a working knowledge of USP, 9 CFR, 21 CFR, Health Canada and related guidelines. 
 
Sandra has written and implemented Quality Systems Manuals and other Tier I- IV Documents including Master Validation Plans, Site Reference Files, HACCP Plans, Qualification Protocols and Standard Operating Procedures.  She has extensive experience auditing laboratory, manufacturing, warehousing and quality systems and has developed process flow diagrams for both systems and processes.  Sandra has performed risk assessments and GAP analysis on validation programs, manufacturing processes, and quality systems.  She has developed and implemented extensive training systems for cGMP compliance.
 
Sandra has managed daily activities and developed Systems for Analytical and Microbiological Laboratories and specializes in microbiological control of aseptic processes and water systems. She has implemented solid microbiological monitoring programs for effective contamination control in aseptic areas and validation of cleaning processes.
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Arlen Johnson
Senior Specialist – Regulatory

A North Dakota State University graduate, Arlen holds Bachelor of Science in chemistry.  He has over 15 years experience in Quality and Regulatory with diverse projects in Medical Device Manufacturing, Aseptic Processing, industrial coatings and application systems.  Arlen has successfully submitted product applications for 510k submissions, NDA/ANDA submissions, EN 46001 (ISO13485), CE marks according to EC MDD93/42 and Master Device Records for DEKRA approval.  He has implemented and enforced of cGMP, Quality Systems, and MDD 93/42.  Arlen has a proven record of interaction with regulatory agencies acting as a primary FDA coordinator and responding to 483. 
 
Arlen co-managed a project construction and validation of a 5,000 square foot Class 10,000 clean room facility and assisted in the relocation of the manufacturing facility, including production line design, warehouse material flow arrangement, and energy requirements.  He managed the environmental validation of the new production facility and the process validation of new production line.  Arlen has a diverse knowledge of manufacturing, having managed Regulatory Affairs, Quality Assurance, Quality Control and Manufacturing.
 
Arlen has formulation and product/process development skills in diverse areas of wound dressings, food, drilling fluids, industrial polymers and multi-component chemical products.  He has created packaging designs for Class II sterile medical devices encompassing cost, efficiency, marketable quantities, compliant labeling and package presentation.
 
Arlen holds a certification as a Sicherheitsbeauftager fur Medizinproducte.
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Joseph Kupec
Project Manager

A graduate of Pennsylvania State University, Joe has over 13 years domestic and international (EU) industrial cGMP experience including: bulk chemical, solid dosage, parenteral, and biopharmaceutical applications.  He has extensive experience in conducting audits of bulk, solid dosage, parenteral and biologic pharmaceutical facility processes, utility systems, analytic laboratories, calibration, and maintenance programs. 
 
Joe has a solid background in design review, commissioning management, and execution of qualification protocols for process equipment, utility systems, and facilities.  His areas of expertise include HVAC systems, purified water systems, WFI systems, clean steam systems, CIP/SIP systems, compressed gas systems, Lyophilizers, Depyrogenating Tunnels, and Cold rooms.
 
Joe is process oriented and excels in creating process flow diagrams and generations/review of critical assessment reports. His attention to detail allows a full assessment that is critical to the effective Master Validation Plans and Project Plans that he has written.
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Hamid Amellal
CSV Manager

Hamid holds a Bachelor of Science in Electrical Engineering from the University of Massachusetts and has taken several post graduate engineering courses from Boston University. Hamid has an extensive computer validation background in an FDA regulated environment.  He is certified in FDA Auditing of Computerized systems and is certified in 21 CFR Part 11.  He has been responsible for overall Protocol development of IQs, OQs and PQs and also has engineered changes to existing equipment and processes to support internal manufacturing processes.

Hamid was responsible for the design, procurement, documentation, commissioning and validation of process controlled pharmaceutical/biotechnical equipment.  He has experience from simple PLC to complex robotic system validation.  Systems that Hamid has validated are diverse; from HVAC systems, warehouse management systems, computer controlled manufacturing systems, and laboratory LIMS systems.  Hamid generated remediation plans to describe processes, resource, and milestones that bring computerizes systems such as ICOS Stopper Washer and Pressure Monitoring System into compliance with 21 CFR Part 11.  He has prepared Gap Analysis and Risk Assessments in regards to 21 CFR Part 11 bound computerized systems.

Hamid has experience in operating systems such as DOS, Windows, OS/2 SunOS, HPUNIX, ALPHA, and VAX/VMS RSX-11 for PDPs and programming languages such as data structure and C, C++, JAVA, UNIX Shell, FORTRAN, Assembly.  He has developed and customized database reports and integrated them into core application software.
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