Week 1 Lecture File - lms.manhattan.edu
Download
Report
Transcript Week 1 Lecture File - lms.manhattan.edu
Manhattan College
Fall 2012
Class 1
Agenda
• Introduction
• Review Syllabus
• Break
• Module 1: Industry Regulations Overview
Introduction
Robert Lechich Background
Pharmaceutical and Biotech Industry (over 25 yrs)
Manufacturing/Operations: API, Solid Dosage, Sterile, Biotech and
Packaging
Quality Assurance
Process Engineer, Facility and Maintenance Management
Plant Automation, Info Management
Supply Chain Management, Contract Manufacturing
Academic
BE Chemical Engineering
MS Technology Management
Graduate Certificate in Quality Assurance/Regulatory Affairs
Certificate in Supply Chain and Logistics
Certifications
CPIM, CPIP, CSCP, Six Sigma Master Black Belt, PMP
Societies
AICHE, ASQ, CSCMP, APICS, ISPE, PMI
Introduction
Students
Name
Background (Academic, Work Experience, etc.)
Mention something interesting about yourself
Reason for Taking Course
Introduction
Syllabus
Introduction to Course
Learning Goals and Objectives
Learning Philosophy
Pedagogy
Required Readings
Additional Requirements
Assignments
Introduction to Course
Industry Regulations
Need for Regulations
Regulations Overview
Impact on Industry
Introduction to Course
Quality Systems
Product Quality
Concurrent Engineering/Design for Quality
Quality Function Deployment
Quality Control, Inspection and Testing
Training and Documentation
Change Control, Quality Risk Management, Quality
Audit
Validation, Process Monitoring and Control
Quality Organizations and Culture
Introduction to Course
Quality Improvement Techniques
Total Quality Management
Reliability Engineering
Business Process Engineering
Lean Six Sigma
Learning Goals and Objectives
Understand different industries needs of regulations and
how they apply to firms especially in the process industries
Understand and how to apply quality management
principles to a variety of situations such as chemical,
cosmetics, drug, medical device, food and dairy industries
Understand quality improvement and lean six sigma
concepts to the areas of process design, operations and
support services
Introduction
Learning Philosophy
Learning is supported by collaboration between
instructor and students.
Active participation is required. Learning is not equal to
teaching.
Support multiple ways of student learning.
Pedagogy
Lecture
Readings
In Class Discussions (Participation)
Homework
Case Studies (Participation)
Individual Exams (Midterm and Final)
Required Readings
Akao, Yoji, Quality Function Deployment
Gryna, Frank M., Quality Planning and Analysis: From Product
Development Through Use
George, Michael et al., Lean Six Sigma Pocket Toolbook
Nash, Robert., A. Wachter, Pharmaceutical Process Validation
Tobin, John J., G. Walsh, Medical Product Regulatory Affairs
Excerpts from Government Regulations (Provided by Instructor)
Excerpts from Lean Six Sigma literature (Provided by Instructor)
Case Studies (Provided by Instructor)
Additional Requirements
Case Studies
Additional Supplemental Readings will be provided
Access to Statistical Software: Minitab, JMP, etc.
Assignments
Class Participation/Exercises
Homework, Case Studies
Midterm Exam (In Class)
Final Paper/In Class Presentation
Final Exam (In Class)
10%
20%
20%
20%
30%
Questions???
Module 1
Why are Regulations necessary?
Regulations Overview
Regulations Comparison across Industries
Government and Industry Perspectives
Why are Regulations Important
Competing forces between individuals
Considerations beyond the individual or the single
firm
Protection of
Humans
Commerce (free market)
Society
Physical Environment (air, water, land)
Regulatory Overview
Congress creates laws
i.e. Consumer Products Act, Food, Drug and Cosmetic
Act
Federal department write regulations to implement
authority of laws
(international, country, local region/state)
Code of Federal Regulations (US)
Sections dealing with different areas
Title, Section Examples
Title 21 Food and Drugs
Title 29 OSHA
Title 40 EPA
Regulatory Overview
Common Regulations
Product Safety
Environment Protection
Occupational Safety and
Health
Unique Regulations
DOE
USDA
Food
Drug
Cosmeti
cs
Medical
Devices
Nutraceu Fine
ticals
Chemica
ls
FDA
FDA
FDA
FDA
FDA
Depends
EPA
EPA
EPA
EPA
EPA
EPA
OSHA
OSHA
OSHA
OSHA
OSHA
OSHA
USDA
Energy
EPA
DOE
Regulatory Overview
Entities Involved
Government Agencies
Standards Organizations
Professional Societies
Lobby Groups
Industry Firms
Government Perspective
Legislative Branch
Created departments supporting specific areas
Department of Energy
Department of Defense
Food and Drug Administration
Environmental Protection Agency
Violations of the Regulations (and underlying law)
Fines, sanctions, closures, and jail time
Government Perspective
Federal Agencies support self-monitoring and
reporting
Needs far out way the capacity of agencies
Voluntary updates to the agencies
Globally
Different Countries with different laws and regulations
Same intentions though
Barriers and Harmonization across borders
Standards Bodies
Develop standards for technical, process or testing
International Bodies
International Standards Organizations (ISO)
Institute of Electrical and Electronics Engineers (IEEE)
National Bodies
ANSI, NIST, ASTM
Independent organization
ASME, USP/NF
Usually Adopted by Industries to ensure regulations
are met or to simplify business activities
Professional Societies
Develop Guidelines or Guidances
Help firms to meet the legal requirements
Usually are not put into law
Could be developed and supported by the government
agencies
Examples
International Conference on Harmonization (ICH)
Drug Development and Quality Perspectives
Cosmetic Industry Excipients (Check it)
Lobby Groups
Role to actively support their industry to Congress or
other government organizations on behalf of the
industry
Examples
PhARMA: Pharmaceutical Industry
Americal Chemistry Council: Plastics
Personal Care Products Council: Cosmetic Industry
Industry Perspectives
Strategy to support regulations
Product Innovation
Establish Customers
Manufacturing and Supply Chain
Establish Goals
Financial goals
Environmental Impact
Industry Perspectives
Organization Structure
Separate Quality and Manufacturing departments
Regulatory and legal departments
People Responsibilities and Training
Train personnel in safe operations
Processes (Business and manufacturing)
Check and Balance
Documentation requirements
Technology
Select technology that meet regulations
Technology establishes new regulatory expectations
Is there ever too much regulation?
Can too much regulation become a problem for
industry, can businesses survive
Will regulation protect the individual, society or both
Need to continually ask the question to ensure proper
level to balance industry and society/environment/etc.
What about ethics?
Does ethics play a part in developing regulations?
The relationship between ethics and creating law
Doing the right thing from a society standpoint translate
into clear regulations?
Regulations enforces ethics or maybe would is
interpreted into law!!!
Homework Assignment No. 1
Pick industry from list.
Food
Dairy
Drug
Cosmetic
Medical Devices
Nutraceuticals
Fine Chemicals
Plastics
Energy
Water/Wastewater
Biotechnology
Air Pollution
Homework Assignment No. 1
Research the area and write a one-two page paper covering
the following questions:
1.
2.
3.
4.
5.
Describe the major U.S. regulations influencing that area?
Select one other country or region and cover its regulations?
What government agencies are involved? (hint: maybe more than
one)
How does it impact the product?
How does it impact the manufacturing process?
Be prepared to lead class discussion next week (no
presentation is required but must submit paper to
instructor
Homework Assignment No. 2
Critique the GMO case study
Use the guidance provided in class and in the syllabus