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Course Syllabus
This course syllabus is a general plan for the course; deviations
announced to the class by the instructor may be necessary.
In .pdf format
Contents:
UGA Faculty and
Staff
Course Instructor:
Name: Saundra
Granade, M.S. Microbiology, Pharmaceutical Industry Consultant
Email:
sgranade@rx.uga.edu
Phone
& Fax: 706-310-0086
Program Director:
Name: David W.
Mullis, Jr., Ph.D., RAC, Director Regulatory Affairs Graduate Education
Program
Email: mailto:dmullis%20@rx.uga.edu
Office
location: B2340 Gwinnett University Center
Office hours: Mon. &
Fri. 9:00 am to 2:00 pm , Tues 9:00 am-Noon
Phone & Fax:
678-407-5181
Course Support (including technical
support):
Johnna Hodges, M. Ed., Program Manager
Email:
jhodges@rx.uga.edu or Phone &
Fax: 678-407-5180
Angie McVey, Program Coordinator
Email: amcvey@rx.uga.edu or Phone & Fax: 678-407-5277
When emailing faculty and staff, please allow a reply time of 24-48
hours if you submit your email during the week. If you submit a question
over the weekend, please allow additional response time.
Course Instructional
Staff:
Saundra Granade, M.S. Microbiology, Pharmaceutical Industry
Consultant
College of Pharmacy
University of Georgia
Robert C. Coleman
Investigator, National Drug Expert
Food and
Drug Administration
Course Description:
PHAR
6030 is one of the core courses required for the certificate program
and/or for the Master of Science College of Pharmacy with emphasis in
regulatory affairs. This course provides an overview of FDA guidelines and
cGMP’s. The primary goal of this course is to provide students with a
focused exploration of the regulatory guidances and how they are applied
in the pharmaceutical and biotechnology industries.
This course will provide students the opportunity to understand the
application of the regulations to manufacturing processes in establishing
quality systems that ensure compliance to product and process
commitments.
Prerequisites: Permission of Department
Course
Objectives:
Upon completion of PHAR 6030, students will be
able to demonstrate:
1. An understanding of FDA Guidelines including:
- Describing the purpose of the various guidelines and policies
- Discussing the ramifications when the regulations are not followed
- Summarizing the requirements for submissions and inspections
- Explore, describe, & discuss the interpretative aspects of the
guidance’s and how they can be applied to manufacturing operations
2, An understanding of cGMP’s and their application to the healthcare
industry including:
- A history of cGMP’s
- Principles and approaches in Medical Devices
- Principles and approaches in Pharmaceutical Drug products
- Principles and approaches in Veterinary products
- Application of cGMP’s in Europe
- General quality assurance principles to be applied to
manufacturing operations
3. An understanding of Freedom of Information:
(Through navigational
techniques)
How to utilize the electronic reading room, including
sourcing reference documents, results of inspections and regulatory
memorandum
4. An understanding of filing requirements for new products and
processes; including the impact of FDA guidelines, policies and cGMP’s
though the reading assignments and presentations.
5. An understanding of the Quality System Inspection Technique
including:
- Definition of the types of inspections
- Definition of quality systems and how they are to be
monitored
6. An understanding of how changes in manufacturing are to be
controlled.
7. An understanding of Pharmaceutical cGMPS for the 21st Century — A
Risk-Based Approach
Course Materials and
Recommended Reading:
Materials and Readings:
Other readings will be through access to documents available through
the FDA web site. These will be referenced throughout the on-line course
materials.
Materials: A variety of materials and methods will be employed
in providing the information for PHAR 6030. Instructional techniques to be
utilized will be digital and live lectures, PowerPoint presentations,
reading materials and interactive exercises.
Assignments:
A. Review the following three assignments. Choose two of the
three.
- Identify a warning letter for a manufacture.
Prepare a report that includes which guideline(s) the firm was out of
compliance with. What systems need to be enhanced to improve the
manufacturing processes. Define what types of actions need to be taken.
- Review an EIR for a manufacture. Write a summary report detailing
the compliance issues and what systems need to be in place to prevent
reoccurrence.
- Review the warning letters for 2003 or 2004 for one of the following
agencies. Identify if there is a trend. What systems need to have focus
to resolve the issues? What types of actions should be taken.
B. Design of a drug product.
You are to design a pharmaceutical drug, device,
biologic, combination product or veterinary product to manufacture. This
can be done as an individual or as partners (no more than 2 people per
team). A process flow diagram should be prepared to include
identification of systems that need to be in place to successfully pass
a cGMP inspection. Identification of the regulatory guidelines and
policies that you need to provide the minimum requirements for
compliance should be noted throughout your development process. A
presentation is to be prepared to introduce your product. The
presentation is to include but not limited to:
- Process flow diagram
- Quality Systems required to support compliance shall be
identified and a brief definition of system purpose, controls and
monitoring is to be provided for each of the following:
- Manufacturing Systems
- Materials Systems
- Packaging and Labeling Systems
- Facilities and Equipment Systems
- Laboratory Controls Systems
Presentations will be made to the class.
Presentations may be as individuals or in groups of two individuals. The
presenters will defend their product and processes with respect to
Quality systems identified. Each presentation will be challenged during
their presentation for compliance to cGMP’s.
The presentations are due on or before July 23, 2005.
Presentations will be made on July 30, 2005.
Presentations should be delivered as though you are a regulatory
affairs profession and are communicating this information to the general
management and/or FDA. Your presentation should be in line with business
dress and etiquette.
C. Audit Checklist
cGMP’s ensure consistency in manufacturing products. The inspection
guides and cGMP’s assist the investigators in performing inspections of
facilities as well as reviews of applications and data. You are to
develop an audit checklist that addresses the minimum requirements as
identified in 21 CFR 211, Current Good Manufacturing Practice for
Finished Pharmaceuticals
Prepare and audit checklist utilizing the 21 CFR 211, Current Good
Manufacturing Practice for Finished Pharmaceuticals. The checklist is to
use the following format:
|
Section of CFR |
Definition |
Audit Points |
|
211.22 |
Responsibilities of quality control unit |
- Quality assurance personnel are responsible for final
release of product to market.
- Materials are received, evaluated for acceptance, and
released for use by a quality unit.
- A quality system is in place for the tracking and
accountability of approved, quarantined and rejected materials.
- The quality unit is responsible for the control over
quarantined and rejected materials
- The quality unit is responsible for the approval process for
procedures and specifications related to the manufacture of the
product.
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Web Exercises:
During most weeks of the course, you will be
required to complete web exercises that involve searching for and
reviewing materials on the FDA web site. The goal of these exercises is
to help you to become familiar with references available on the web and
to help you to become familiar with the FDA web site, search tools and
techniques that can be used to access compliance requirements.
At the conclusion of each module, you will be required to submit an
exercise that will gauge your level of knowledge on the recently
presented material. These exercises may be on-line quizzes and small
written assignments to be submitted using the WebCT submission tool.
Important: For any written exercises and assignments
(papers, presentations, etc), use of outside resources must be noted as
a reference using either footnotes or endnotes and a bibliography.
Each student is also required to participate in WebCT bulletin board
and chat room discussion as directed by the instructor. The discussion
board is for asynchronous postings and discussions while the WebCT chat
room is for synchronous discussions. For those synchronous discussions,
you will be advised a head of time on the date and time that you should
be online.
Grading:
Grading:
100-point scale Grade:
| 100-94 = A |
93-90 = A- |
89-88 = B+ |
87-84 = B |
83-80 = B- |
79-78 = C+ |
77-74 = C |
73-70 = C- |
69< D |
59< F |
Grades will be based on each student completing the three assignments
made during the course including web exercises, workbook, discussion
boards and quizzes, as applicable.
May 21, June 25, and July 30 are mandatory class
participation.
- On line Class Participation ( Web Exercises and Quizzes) 20%
- Workbook, Comparison of cGMP’s and Regulations 20%
- Assignments as noted above in the assignment section
A – 10%
B – 30%
C – 20%
All papers must be proofed for spelling errors, grammar, and
punctuation.
Policies and Academic Honesty:
All academic work must meet the standards contained in A
Culture of Honesty. Each student is responsible to inform themselves
about those standards before performing any academic work. A Culture of
Honesty is the University of Georgia's policy and procedures for handling
cases of suspected dishonesty and can be found online at www.uga.edu/ovpi . UGA
Student Honor Code states "I will be academically honest in all of my
academic work and will not tolerate academic dishonesty of others."
Important: For ALL assignments (papers, presentations,
etc), use of outside resources must be noted as a reference using either
footnotes or endnotes and a bibliography.
WebCT Quiz Policies and
Information
Missed Quizzes: You will have a
specific length of time to take an online quiz. Absences or failure to
turn in a quiz by the deadline will result in a failing grade for the
respective test unless there is a bona fide emergency involving the
student or an immediate family member. If such a case occurs, the student
must contact the UGA Regulatory Affairs Graduate Education Program
as soon as possible at (678) 407-5277 or email jhodges@rx.uga.edu.
WebCT Quiz Helpful Hints:
Quizzes will be posted on WebCT.
See WebCT quiz link for exact submission deadlines. In Quiz View, you can
change the size of the frames if needed. Be sure to "Save Answer" for each
quiz question before submitting. Do not use browser's navigation buttons
while using the quiz module. If you lose your connection or close your
browser while taking a quiz, your "saved answers" will be saved until the
next time you open the quiz.
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