John Lauzon seeks a challenging leadership role to leverage his extensive management experience in maximizing company resources and profits. He has over 15 years of experience managing operations and ensuring regulatory compliance at the American Red Cross Blood Services. His experience includes managing inventory, developing process improvements, and serving as the Radiation Safety Officer.
Presented by Lev Feigin
Technical writers for FDA-regulated industries are always in demand. Such writers produce a wide array of documentation, from policies and procedures to quality manuals and employee training, which support good manufacturing practices and ensure compliance with FDA regulations. In this session learn what it takes to excel in the pharmaceutical and medical devices industries as a technical writer and find out what you’ll need to know about the latest documentation practices and requirements to enter the field.
Presented by Lev Feigin
Technical writers for FDA-regulated industries are always in demand. Such writers produce a wide array of documentation, from policies and procedures to quality manuals and employee training, which support good manufacturing practices and ensure compliance with FDA regulations. In this session learn what it takes to excel in the pharmaceutical and medical devices industries as a technical writer and find out what you’ll need to know about the latest documentation practices and requirements to enter the field.
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body functions independently under Department of Science and Technology of the Indian Government. NABL is registered via the societies act
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Trust, but Verify - Tips & Tools for FSMA's Foreign Supplier VerificationTraceGains
The FDA’s Food Safety Modernization Act (FSMA) rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is now final, and compliance dates for some businesses begin in 18 months. To help the food supply chain prepare, TraceGains’ will zero-in on the FSVP in its upcoming webinar: “Trust, but Verify – Tips and Tools for Foreign Supplier Verification (FSV).”
TraceGains will host FDA attorney Marc Sanchez as its guest speaker for the webinar. The session is designed to give an overview of the key provisions and tips and tools you can use to simplify compliance with the new requirements and establish a world-class FSVP.
Specifically, the webinar will cover:
Examining your current supplier program and how to identify gaps in hazard analysis;
What the FDA says about electronic record-keeping for FSV;
What involvement is expected from the executive and management level;
Third-party verification of foreign suppliers;
Risk management best practices for FSV; and,
Tips & tools to simplify compliance with FSV.
Pharmaceutical industry is a very vital segment of the
our health care system, which deals with manufacturing
and marketing of pharmaceuticals and biological
products and medicinal devices, used for the diagnosis
and treatment of diseases as well as conducts research
for development of new products for human welfare
TQM involves
building quality in a pharmaceutical product as it
involve complete records such as standard operating
procedures for every step, validation records, master
formula records and batch production records etc.
Chill Out About FSMA - It's Complex, but it's Not Rocket ScienceTraceGains
Nervous about FSMA? With such sweeping changes to the food safety landscape, it’s only natural to be a little nervous. Especially when you consider the voluminous pages of regulatory language, several rules are still pending, and FDA's plan to develop and offer training to industry is still unfolding. In response to these challenges, TraceGains has developed a new webinar series on FSMA readiness with FDA attorney Marc Sanchez to help make the tasks ahead a little less daunting.
The webinar “Chill Out about FSMA - It’s Complex, but it’s Not Rocket Science,” is designed to give an overview of FSMA's key provisions and the implementation timeline. Specifically, guest speaker Marc Sanchez will:
Interpret the rules and guidance published FDA on assembling a qualified food safety team;
Discuss how to analyze exiting quality and safety systems and identify gaps; and,
Offer strategies to document training and implementation of a FSMA-compliant food safety plan.
Fda initiative on process analytical technologyVaishaliMundhe1
Process Analytical Technology is used to describe optimal applications of process analytical chemistry tools, feedback process control strategies, information management tools and process / product optimization strategies to the manufacture of pharmaceuticals.
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body functions independently under Department of Science and Technology of the Indian Government. NABL is registered via the societies act
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Trust, but Verify - Tips & Tools for FSMA's Foreign Supplier VerificationTraceGains
The FDA’s Food Safety Modernization Act (FSMA) rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is now final, and compliance dates for some businesses begin in 18 months. To help the food supply chain prepare, TraceGains’ will zero-in on the FSVP in its upcoming webinar: “Trust, but Verify – Tips and Tools for Foreign Supplier Verification (FSV).”
TraceGains will host FDA attorney Marc Sanchez as its guest speaker for the webinar. The session is designed to give an overview of the key provisions and tips and tools you can use to simplify compliance with the new requirements and establish a world-class FSVP.
Specifically, the webinar will cover:
Examining your current supplier program and how to identify gaps in hazard analysis;
What the FDA says about electronic record-keeping for FSV;
What involvement is expected from the executive and management level;
Third-party verification of foreign suppliers;
Risk management best practices for FSV; and,
Tips & tools to simplify compliance with FSV.
Pharmaceutical industry is a very vital segment of the
our health care system, which deals with manufacturing
and marketing of pharmaceuticals and biological
products and medicinal devices, used for the diagnosis
and treatment of diseases as well as conducts research
for development of new products for human welfare
TQM involves
building quality in a pharmaceutical product as it
involve complete records such as standard operating
procedures for every step, validation records, master
formula records and batch production records etc.
Chill Out About FSMA - It's Complex, but it's Not Rocket ScienceTraceGains
Nervous about FSMA? With such sweeping changes to the food safety landscape, it’s only natural to be a little nervous. Especially when you consider the voluminous pages of regulatory language, several rules are still pending, and FDA's plan to develop and offer training to industry is still unfolding. In response to these challenges, TraceGains has developed a new webinar series on FSMA readiness with FDA attorney Marc Sanchez to help make the tasks ahead a little less daunting.
The webinar “Chill Out about FSMA - It’s Complex, but it’s Not Rocket Science,” is designed to give an overview of FSMA's key provisions and the implementation timeline. Specifically, guest speaker Marc Sanchez will:
Interpret the rules and guidance published FDA on assembling a qualified food safety team;
Discuss how to analyze exiting quality and safety systems and identify gaps; and,
Offer strategies to document training and implementation of a FSMA-compliant food safety plan.
Fda initiative on process analytical technologyVaishaliMundhe1
Process Analytical Technology is used to describe optimal applications of process analytical chemistry tools, feedback process control strategies, information management tools and process / product optimization strategies to the manufacture of pharmaceuticals.
Mapa conceptual que describe de forma detallada lo que significa la gerencia de proyectos, sus características y procesos. Así como, el funcionamiento del ciclo de vida de los proyectos.
"No dia 16 de outubro comemorou-se na nossa escola o "Dia da Mundial da Alimentação". Esta comemoração, que teve início em 1981, é na atualidade celebrada em mais de 150 países como uma importante data para consciencializar a opinião pública sobre a questões da nutrição e alimentação. Posto isto, a turma H do 6.ºano da nossa escola elaborou trabalhos muito criativos, na disciplina de Ciências Naturais, sendo estes expostos na sala dos professores e na biblioteca da nossa escola."
1. John Lauzon
563 Bourne Rd Plymouth, MA 02360
(781) 708-6171 lauzonjohn@yahoo.com
J. Lauzon Page 1
OBJECTIVE
My Professional objective is to join an organization in a challenging leadership role, allowing me to leverage
my extensive management experience, creative problem solving and lean management skills with a growing
company to achieve optimum utilization of its resources and maximize profits.
2001 – TD American Red Cross Blood Services Massachusetts Region, Dedham, MA
08/2011 – TD Northeast Region Distribution Manager / Radiation Safety Officer
Responsible for union department of 34 staff and four supervisors at two locations while directing the
processes of storage and distribution of blood products, irradiation, and temperature monitoring of all
regulated areas.
Manage daily inventory of over 20,000 units while working cross functionally to meet the need of 200
customers across four states.
Developed corrective action presentation which resulted in 100% problem reduction from FY14 to FY15
and was adopted for use system-wide for overall compliance.
Spearheaded new process to bring in new customers which showed profit of $10K within a 4 month
period.
Coordinated a volunteer work force to lower operational costs and increase revenue by $5,000 in a two
month period
Radiation Safety Officer for both Massachusetts and Vermont locations; authored, audited and
maintained compliance with all Nuclear Regulatory Commission regulations
Developed and implemented new customer on-boarding process in order to ensure customer needs were
met while also maximizing current route schedules
Identified and opened new collection site to ensure seamless pickup and delivery of products and
supplies
Successfully provided operational support during deployment of new software system at 4 distribution
sites (Columbia, Puerto Rice, Rochester, and St. Paul)
02/2009 – 08/2011 Manufacturing Manager, Quarantine and Labeling
Responsible for union department of 45 staff and four supervisors while overseeing the processes of
pheresis manufacturing, sample tube management, irradiation, quarantine, labeling, disposal
management, and freeze, wash, and deglycerolization of red blood cells.
Established and organized weekly interdepartmental meetings to reduce products in quarantine
Worked cross functionally to successfully implement strategic initiatives through change control
processes
Maintained control of blood products by reducing work in progress inventory and ensuring accuracy of
electronic and physical inventories
Designed and implemented a new bacterial detection process that resulted in increased productivity and
subsequent platelet apheresis sales
Responsible for procedural development for the Freeze/Wash/Deglyc task including analyzing current
processes, problem data, CFR Regulations, customer needs and non-value add processes with the goal
of standardization
Radiation Safety Officer for the Massachusetts Region; Procedure development and implementation to
ensure compliance with all state and federal regulations.
2. John Lauzon
563 Bourne Rd Plymouth, MA 02360
(781) 708-6171 lauzonjohn@yahoo.com
J. Lauzon Page 2
04/2007 – 02/2009 Regulatory Manager, Hospital Services and Distribution
Worked cooperatively with other managers to establish long range planning in order to achieve business
goals
Served as a member of the Regulatory Committee which reviewed draft documents with Biomedical
Headquarters before release and implementation across the system
Prepared department for audits with Food and Drug Administration, Occupational Safety and Health Act
standards, and internal Quality Assurance reviews and inspections.
Ensured continued regulatory compliance by overseeing problems, quality control, corrective actions and
internal audits.
05/2006 – 04/2007 Operational Compliance/Quality Assurance Specialist
Identified and assessed quality risks in processes and procedures according to regulations and guidelines
Facilitated root cause analysis, develop corrective action plans, and monitored for effectiveness
Identified opportunities for standardization and process improvements in order to improve quality
Lead internal compliance audits, provided support for external audits, and composed audit reports
Reviewed and approved regional procedures, change controls, validations and critical control points in
operational documents
Represented the Quality Department on projects, work groups, and process improvement efforts both
within the department and within other areas of oversight
02/2002 – 05/2006 Production Supervisor, Quarantine and Labeling
Responsible for a shift of 15 staff while overseeing the production of 470,000 blood products and
ensuring compliance with industry regulations and Red Cross standards including SQuIPP, CLIA and
CFR requirements
Designed and supervised the renovation of a 4.7 million dollar production lab with staff safety and
efficiency of work flow as the primary goals
EDUCATION
05/2000 Saint Joseph’s College, Standish, ME – Bachelor of Arts: Biology, Minor: Chemistry
CERTIFICATIONS/SKILLS
Radiation Safety Officer
Computer competent with Microsoft Windows, Word, Excel, and Internet Navigation
Proficient in CFR/FDA, AABB and Nuclear Regulatory Commission requirements
Directing operations in a GMP environment
REFERENCES
Available upon request