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
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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)
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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