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Costas B. Chantzis, John Donohue
and Barry Graziano are your tried, tested and proven consultants
and experts because they have 27, 29 and 35 years, respectively, of
impressive and verifiable industrial accomplishments in the medical
device, pharmaceutical, biotechnology, life science, healthcare and
industrial goods markets. Check it out here
or ask to speak with anyone of them. You got nothing to loose BUT lots
to gain!!!
Feel free to download our company's brochure.
Our services include:
- Business/Operational Excellence
- Continuous Process Improvements
- LEAN Six Sigma Operations
- Manufacturing and Operational Improvements
- Quality and Productivity (Process/System) Improvements
- Six Sigma Operations
- Baldrige Business Transformation
- Process Modeling, Simulation, Design,
Development and Optimization
- Process Troubleshooting
- Supply Chain Management
- Intellectual Property Audits
- Technology Audits
- Business Due
Diligence Audits
- Research and Development, Technology
Transfer and Remediation
- Training
Our Business
Excellence record includes:
Summary:
Costas
B. Chantzis, pharmaceutical, medical device, biotechnology, life science,
healthcare, industrial goods markets consultant, expert. He
has had an impressive and verifiable list of industrial accomplishments
for 27 years in business / operational excellence, Six Sigma,
Baldrige business transformation, continuous process improvement, re-engineering,
turnaround, validation, regulatory compliance, intellectual property and
business due diligence, research and development, technology transfer,
process/system improvement and remediation, models/templates for due diligence
of regulatory compliance and operational excellence comprising systems
of quality, facility and equipment, materials, production, packaging and
labeling, laboratory controls as well as intellectual property, product’s
commercialization phases, cost of quality, performance and productivity,
manufacturing plants, and business entities, biomaterials, material
surface treatment, tribology, colloids, cutting tools, membranes, powders,
gels, fluid pumping and processing, aseptic filling, lyophilization, sterilization
and packaging, process
analytical technology, quality by design, quality function deployment, design
controls, system/component impact assessment, critical process parameters,
critical quality attributes, deviation investigation, corrective action
and preventative action (CAPAs), quality risk assessment, quality risk
management, PMA, 510K and IDE, modeling, statistics, Six Sigma and Baldrige
performance, lean manufacturing quality and productivity tools with
an impressive and verifiable list of accomplishments in pharmaceuticals,
medical devices, biotechnology, life science, healthcare and other industrial
sectorprojects.
–Twenty-seven
years of experience in business / operational excellence, Six Sigma, Baldrige
business transformation, continuous process improvement, re-engineering,
turnaround, validation, regulatory compliance, intellectual property and
business due diligence, research and development, technology transfer,
process/system improvement and remediation with an impressive and verifiable
list of accomplishments in pharmaceuticals, medical devices, biotechnology,
life science, healthcare and other industrial sectors
–Have
leading edge knowledge in biomaterials, material surface treatment, tribology,
colloids, cutting tools, membranes, powders, gels, fluid pumping and processing,
aseptic filling, lyophilization, sterilization and packaging
–Have
developed proprietary models/templates for due diligence of regulatory
compliance and operational excellence comprising systems of quality, facility
and equipment, materials, production, packaging and labeling, laboratory
controls as well as intellectual property, product’s commercialization
phases, cost of quality, performance and productivity, manufacturing plants,
and business entities
–Have
thorough know-how in process
analytical technology, quality by design, quality function deployment, design
controls, system/component impact assessment, critical process parameters,
critical quality attributes, deviation investigation, corrective action
and preventative action (CAPAs), quality risk assessment, quality risk
management, PMA, 510K and IDE, modeling, statistics, Six Sigma and Baldrige
performance, lean manufacturing quality and productivity tools
–Have
helped such companies as Eli Lilly, Purdue Fredricks Laboratories, Johnson
& Johnson, Schering-Plough, Sharp (Pharma. Contract Manufacturer),
B. Braun, Alcoa, Minolta, B. F. Goodrich, Kimberly Clark, Abbott Laboratories,
Medtronic, Cardinal, and numerous start-up ventures realize millions of
dollars in quantifiable benefits
Barry Graziano, pharmaceutical,
medical device, biotechnology, life science, healthcare, industrial goods
markets consultant, expert. He
has had an impressive and verifiable list of industrial accomplishments
for 35 years in regulatory
compliance, quality risk assessment, quality risk management, fda, internal
and external audits, process analytical technology (PAT), Drug/Device
quality assurance and regulatory affairs: New product validation and design/transfer
including design reviews. Experience leading global quality system software
implementation/ validation projects. Extensive FDA/ISO/QSR training, auditing
(developed internal and external audit programs) and procedure development.
Twenty years experience with customer complaint investigation and resolutions
that yielded increased market share. Expert in applying Quality Improvement
Principles such as Corrective Action and Preventative Action (CAPA) to
a large variety of processes, primarily chemical based, also includes biological,
woven / non-woven textiles, stainless steel devices, tablet, capsule, Large
Volume Parentals (LVP's), Small Volume Parentals (SVP's), rubber, glass
and plastics. Responsible for QA and validation of class 100 environments,
Ethylene oxide, Cobalt 60 sterilization processes. Provided strategic leadership
for re-engineering and quality improvement that yielded significant competitive
advantage. Proven cost cutter, systematic problem preventer, and inspirational
people developer/educator.
35
years experience in Drug/Device quality assurance and regulatory affairs:
New product validation and design/transfer including design reviews. Experience
leading global quality system software implementation/ validation projects.
Extensive FDA/ISO/QSR training, auditing (developed internal and external
audit programs) and procedure development. Twenty years experience with
customer complaint investigation and resolutions that yielded increased
market share. Expert in applying Quality Improvement Principles such as
Corrective Action and Preventative Action (CAPA) to a large variety of
processes, primarily chemical based, also includes biological, woven /
non-woven textiles, stainless steel devices, tablet, capsule, Large Volume
Parentals (LVP's), Small Volume Parentals (SVP's), rubber, glass and plastics.
Responsible for QA and validation of class 100 environments, Ethylene oxide,
Cobalt 60 sterilization processes. Provided strategic leadership for re-engineering
and quality improvement that yielded significant competitive advantage.
Proven cost cutter, systematic problem preventer, and inspirational people
developer/educator.
John Donohue, pharmaceutical,
medical device, biotechnology, life science, healthcare, industrial goods
markets consultant, expert. He
has had an impressive and verifiable list of industrial accomplishments
for 29 years in Analytical Laboratory Test Services for Regulatory Compliance
projects. His regulatory compliance record includes:
Summary:
John Donohue is Director of Laboratory
Test Services for TechnoBusiness Solutions. He is well known in the medical
device industry since 1978. He has developed several successful methods
for predicting the shelf life of products such as the failure or breakage
of polymeric delivery systems, the chemical and physical effects of sterilization
and radiation, and the dramatic entry of Metallocene Polymers into industry.
John has had numerous publications in MDDI magazine, Medical Plastics and
Biomaterials magazine, and has been a regular speaker at the ANTEC, Worldwide
Metallocene Conference, and the Specialty Polyolefins Conference. One of
John's unique abilities is the combined and synergistic use of analytical
instrumentation, chemistry, and knowledge of industrial practice to solve
material and/or processing problems that disrupt product development and/or
production. His favorite machine is a FTIR Microscope and can literally
do wonders with it by using it as a powerful secret weapon to uncover root
causes to complex industrial material, manufacturing and product problems.
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