PHAR 6100 – Quality Assurance Quality Control 1

Course Syllabus

PHAR 6100 Quality Control and Quality Assurance

Spring 2016 CRN: 24-160

This course syllabus is a general plan for the course; deviations announced to the class by the instructor may be necessary. Contents:

UGA Faculty and Staff

Disability Statement

Course Description

Course Objectives

Course Materials and Recommended Reading

Equipment

Assignments and Quizzes, etc.

Assignments

Major Research Project

Method of Instruction

Participation and Attendance Policy

Real-time attendance policy

Class Meetings

Grading

Assignments, Quizzes, etc.

Academic Honesty

Other Policies

Communication

Topical Outline and Course Calendar

UGA Faculty and Staff

Instructor

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Course Support (including technical support)

When emailing faculty and staff, please allow a reply time of 24-48 hours. If you submit a question over the weekend, please allow additional response time. For assignment grades to be returned, please allow at least 72-business hours.

Disability Statement:

The University of Georgia Regulatory Affairs Program is committed to providing reasonable access and accommodations for people with disabilities upon request. If you have a disability and require reasonable accommodations, please contact the instructor by phone, email or an appointment during office hours. If you plan to request accommodations, please also consider registering with the Disability Resource Center.

Disability Resource Center, Division of Student Affairs The University of Georgia, 114 Clark Howell Hall, Athens, GA 30602-3338 (706)542-8719 (voice); (706)542-7719 (fax); (706)542-8778 (tty); email: pbertot@uga.edu and URL: http://drc.uga.edu/ UGA Gwinnett Campus Representative is Dr. Laura Crawley, 678-985-6805, email: lcrawley@uga.edu.

Course Description: PHAR 6100 is one of the core courses required for the Master of Science degree from the College of Pharmacy with an emphasis in Regulatory Affairs. This course provides an overview of FDA guidelines and cGMPs as they relate to Quality Assurance and the Quality Control Laboratories. The primary goal of this course is to provide students with a focused exploration of the regulatory guidance and how they are applied in the pharmaceutical, device, combination and biotechnology industries.

This course will provide students the opportunity to understand the application of the regulations to Quality systems and their relationship to the Quality Assurance and Quality Control functions supporting manufacturing processes.

Credit Hours: 3 credit hours

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Prerequisites: Permission of Department Course Objectives Upon completion of PHAR 6100, students will be able to demonstrate:

1. An understanding of the difference between Quality Control and Quality Assurance.

2. An understanding of what is involved in the establishment of a Quality Systems Manual.

3. An understanding of FDA/ISO Guidelines and standards including: a. The purpose of guidelines, policies, points to consider b. The ramifications when the regulations are not followed c. The purpose of the various guidelines and policies d. The requirements for submissions and inspections e. Explore, describe and discuss the interpretative aspects of relevant

guidances and how they can be applied to establishing quality systems supporting the quality assurance and quality control activities supporting manufacturing.

4. An understanding of cGMPs and their application to Quality Assurance and Quality Control systems supporting the healthcare industry including:

a. Pharmaceutical control laboratories b. Principles and approaches in Medical Devices c. Principles and approaches in Pharmaceutical Drug d. Principles and approaches in Biologics e. Principles and approaches in Combination Products f. Principles and approaches associated with investigations g. Principles and approaches Good Laboratory Practices h. Principles and approaches in method development and validation i. EP/BP/JP/USP, use and certification j. General quality assurance principles to be applied to manufacturing

operations k. Technical requirements l. PAT

5. An understanding of the quality systems as they apply to manufacturing processes focused on application of quality assurance methods.

6. An understanding of the Quality System Inspection Technique and its application to quality assurance and quality control systems.

7. An understanding of Record and Data management.

8. An understanding of various methods of data assessment

Operating System: Remember, we are a PC-based program. If you use an Apple Computer to develop your course work it is YOUR responsibility to ensure that your

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assignment is accessible. You can do this by preparing a PC-formatted version of your assignment. Our office does not support the Apple environment. Course Materials and Recommended Reading Materials: A variety of materials and methods will be employed in providing the information for PHAR 6100. These may include audio lectures, PowerPoint presentations, reading materials and interactive exercises.

Readings: There is no required textbook for this course. The readings will come from a bibliography list and many of these will be available from the internet or library. Typically, the instructor will provide a recommended reading list on a weekly basis. Reading assignments will be through access to documents available through the FDA website and referenced throughout the course materials.

Equipment: For this course, you should have access to a computer microphone. This course may require use of a computer microphone. Either a built-in or external USB microphone is acceptable. Please familiarize yourself with how to use it.

Assignments and Quizzes, etc.

IMPORTANT for ALL CLASSES: As Regulatory Affairs or Clinical Trials professionals and as UGA Graduate Students, our program expects that each assignment be submitted as though you were submitting this task to your Board of Directors, FDA, or other managing body. With this in mind, when you submit a research paper or written assignment, be sure that you:

1. Follow the assignment directions; 2. Paginate your documents; 3. Use your computer’s spell-checking and grammar features; 4. Proof-read your document for typographical and grammatical errors 5. Put your name on the paper or assignment. 6. Finally, be sure that you cite all references for those ideas and quotes that are

not your own. All assignments submitted late automatically lose a letter grade. For each full day beyond the date due an additional letter grade is lost. Assignments: All assignments and papers MUST BE submitted using the eLC Assignment tools. This is mandatory. This is the only way to officially track your work. Email your assignment ONLY if you receive special permission, but you must then follow up with a submission via eLC. Take care also to submit the assignment to the correct submission tool. If you are late turning in your assignment, and can no longer submit your assignment, contact the course support person before emailing your assignment. Final course grades are noted in eLC (unofficial) and the ATHENA (official) system.

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1. Assignments are found within the eLearning Commons system, Assignment Dropbox tool.

2. Saturday, January 9, 2016, we will have a live session as a course

introduction. During that time, you will verbally present your Autobiographical Summary. The purpose of this session is for all of us to get to know one another and for me to gather some background on each of you. Please be prepared to present a brief autobiography to share with your class and the instructor. Areas to include (you may add more) are as follows:

Current employer Describe your role or position How did you achieve your current position? What interests you most about Regulatory Affairs specifically QC

& QA? What are the principle “take always” that you want for this class? What are your career goals within the next 2 and 5 year periods Share something unusual about yourself with the other class

members You will also be posting the autobiography PRIOR to Jan. 9 within eLC for my reference. Details of the teleconference including the call in information are found in the calendar section of this syllabus.

3. Web Exercises: Weekly web assignments involve searching for and reviewing materials on the FDA website. 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 online quizzes and written assignments uploaded in eLearning Commons (eLC).

Major Research Project You will be given a detailed scenario from the instructor that you will use to illustrate the learnings from this course.

a. Presentation: You will present your project both in PowerPoint® presentation format with a pre-recorded audio portion and via a written report. You will be supplied a template for the PowerPoint® presentation. You will record your presentation via Blackboard Collaborate Classroom which is linked in the eLC class.

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Each presentation is to be no longer than 20 minutes in length when recorded. For every minute over 1 letter grade will be lost. You should do the presentation as though you were presenting to your professional colleagues who are very detail oriented but are now in management. All PowerPoint Presentations are due on or before Thursday, April 28, 2016 by 11:59 pm. If you fail to turn in your presentation by this due date, you will be required to present without benefit of your presentation.

Presentations will be recorded using the Blackboard Collaborate system and posted in eLC for viewing. b. Paper: Your paper should be double spaced, 12 point font and be 10-15 pages in length excluding tables, graphs, pictures and references. REFERENCE CITATIONS - Remember to properly document any referenced materials, including websites (including FDA), books, articles, quotes, etc. Failure to cite referenced works or materials is considered a violation of UGA’s Culture of Honesty Policy and could result in failure from this course. The style we recommend is the AMA style (The American Medical Association). It covers medicine, health, and biological sciences. You can use this website, http://www2.liu.edu/cwis/cwp/library/workshop/citama.htm, to view examples.

This research paper is due on or before Tuesday, April 26, 2016 by 11:59 p.m. via eLC Assignment Dropbox tool. Remember to paginate your document. Papers and Presentations turned in without references lists or bibliographies are unacceptable. It will be considered a violation of UGA’s Culture of Honesty Policy to turn in a research project without noting your sources and you may receive a failing grade for the course.

Using Wikipedia as a sole source is unacceptable. If you use Wikipedia, you must cite it AND provide other academic resources for your research. 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.

When required by the instructor, each student is required to participate in online discussions as directed by the instructor. The discussion board is for asynchronous postings and discussions. Teleconferences may also be scheduled during the semester.

Method of Instruction: e-Learning Commons is the course management system that is the primary method of instruction for the delivery of both asynchronous and synchronous content. The live sessions will be indicated in the course calendar. Attendance at these sessions is required. Each session will be held on a Saturday from 9:00 am – 11:00 am. Students should be prepared to discuss or answer any questions

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that they may have or the instructor poses relative to the modules covered to that point. Students may also be asked to present a topic during the live sessions and function as the subject matter expert for Q&A. Participation and Attendance Policy: Student success is dependent upon active participation in all instructional activities. Online courses are no different. However, participation is defined in a different manner. Student "attendance" in online courses is defined as active participation in a) real-time (live) sessions; b) the submission and completion of course assignments by the posted due dates; c) completion of quizzes, tests and other assessments; and d) communication with the instructor. Real-time (Live) sessions are defined as course webinars, face-to-face meetings, teleconferences and chat sessions, all activities that are scheduled ahead of time requiring real-time participation. Students who fail to maintain active participation will have their grades negatively impacted. From the Instructor: All students are responsible for knowing the University’s policy on academic honesty. All academic work submitted in this course must be your own unless you have received my permission to collaborate and have properly acknowledged receiving assistance. It is my responsibility to uphold the University’s academic honesty policy and to report my belief of dishonesty to the Office of the Vice President for Instruction. Netiquette: In this course, and all the courses in the program, you will be required to interact with students and faculty electronically, either through email or eLC Discussion Boards or Chat Rooms. Please follow these simple guidelines of network etiquette.

Please always be respectful of classmates’ opinions and ideas. If you disagree on a topic, do so respectfully and with tact. These discussions are monitored by faculty and often your grade will depend on your participation and the quality and content of your posting. Should you be disrespectful, this may impact your grade.

Do not post anything off-topic in the designated discussion, email or chat topic areas. In each course, there will be a section referred to as the “Coffee Shop” for off-topic discussions. This discussion area is for topics related to Regulatory Affairs, but may not be directly related to your specific course. At no point are you to use any class email addresses, distribution lists or eLC programs for soliciting.

Take care when using humor or sarcasm in emails, discussions and chats. Humor and sarcasm are often hard to convey electronically. It is safest to avoid using it; but if you chose to add humor, consider using emoticons like,,.

As a University of Georgia Graduate Student, you are expected to make every effort to attend pre-scheduled real-time classes in which you are enrolled. As a distance learning student, real-time course participation is infrequent. Thus, when a real-time class meeting is scheduled, you are expected to attend. Real-time attendance policy: Without prior approval from the instructor, a student who does not participate in a real-time class meeting will not be allowed to make-up in-class activities and will be given a grade of 0 (zero) per absence. Examples of excused absences include major illness, bereavement, and religious observances.

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Class Meetings: Please note that Ms. Akelewicz will be available for additional individual and group teleconferences (additional to the published syllabus) upon request. If the group would like to participate in a live discussion, a request in the form of an 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 become familiar with references available on the web and to help you learn some search tools/techniques when faced with new product issues. Some of these exercises may include brief essays that require you to synthesize, interpret or draw conclusions about the materials that you have been reading and receiving during class sessions.

Grading: Grading will be based on the following scale:

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

Table 1: Grading Scale

Assignments, Quizzes, etc.: Grading will be based on each student completing assignments that are made during the course including web exercises, and quizzes, as applicable, and a major project: Company Profile plus its presentation to the class. The following provides weighting for each activity:

Online/Class Participation 20%

Exercises and Quizzes 30%

Final Project (includes PowerPoint presentation & Paper)

50%

TOTAL 100% Table 2: Course Activity scale

Please note that the presentations will be graded on three (3) levels:

Level 1 – For every minute over 20 minutes, a letter grade will be lost. Level 2 – The presenter’s grade will be based on illustrated level of knowledge, solutions offered, level of innovation & cost considerations for the solutions.

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Level 3 – The presenter’s grade will be based on a comparison to other class members work.

Academic Honesty: All academic work must meet the standards contained in A Culture of Honesty. Each student is responsible to inform him or herself 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/honesty. UGA Student Honor Code states "I will be academically honest in all of my academic work and will not tolerate academic dishonesty of others." Be sure to review the section in eLC on Academic Honesty. Prohibited conduct includes “submitting for academic advancement an item of academic work that has been submitted (even when submitted previously by that student) for credit in another course, unless done pursuant to authorization from the instructor supervising the work or containing fair attribution to the original work.” Therefore, you may not submit substantially similar assignments for credit in other courses unless you receive the instructor’s permission to rework that assignment. 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 Instructor or the UGA Regulatory Affairs Graduate Education Program as soon as possible at

Other Policies: This is graduate school and most students are employed full-time, have families and have positions that may require travel. As such, the following policies will be followed for the semester:

Assignments with prior permission to be late will be accepted without penalty. Permission is given freely for international travel. If your international travel interferes with your meeting assignments/quizzes, contact the instructor or course support contact at least 2 weeks prior to travel about your assignment being late before you travel. Domestic travel has been accepted as an excuse on a limited basis. Contact the instructor with any questions.

Assignments without prior permission to be late will lose a letter grade for the day due and any additional day. Experience has shown it is not in your best interest to not turn in or complete an assignment or quiz.

All assignments and papers MUST BE submitted using the eLC Assignment Tool. This is mandatory. This is the only way to officially track your work. E-mail your assignment or paper ONLY if you receive special permission, but you must then follow-up with a submission via eLC. Take care also to submit the assignment or paper to the correct submission tool. If you are late turning in your

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assignment or paper, and can no longer submit your assignment, please contact the course support person before e-mailing your assignment.

Communication: Because we are a distance learning program, the easiest way to communicate with the department is via e-mail. You may e-mail us using the standard e-mail addresses listed in the course syllabus, or you may e-mail directly from your online course. You are also welcome to telephone the course Instructor or make an appointment for a meeting.

Recording your Project Presentation:

As a graduate student and as a working professional, it is important to remind you that you should not wait until the last minute to address your course recording assignment. Each student is responsible for creating a functioning recording as a part of this assignment. This recording is due on the due date noted in the course syllabus. No extensions will be granted. It is your responsibility to ensure that your equipment works with the Blackboard Collaborate Classroom system. Following the Blackboard Collaborate directions to the letter, you are to ensure your presentation has no glitches that impact negatively your message. As such, you should not wait until the last minute to create your recording. You should familiarize yourself with the Blackboard Collaborate technology early in the course. You should provide yourself ample time for a few practice sessions of your presentation. Review those sessions and ensure that slides advance and your voice is audible. This means you should review your archived material. Should you have questions or encounter technical difficulties during this time, alert your course support person.

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Topical Outline and Course Calendar: PHAR 6100 Quality Assurance & Quality Control

This course will begin Saturday, January 9, 2016. New learning modules begin on Saturdays. Assignments and Quizzes are generally due Sundays at 11:59 p.m.

This course calendar is a general plan for the course; deviations announced to the class by the instructor may be necessary. = Dial 1-877-211-7530. When prompted, enter Guest Speaker code 6100.

Saturday Topic Assignment or

Assessment due

Autobiographies due Jan. 7 via eLC. Jan. 7

Jan 9

Teleconference 1: 9 – 11 am General discussion of class objectives, review of student biographies and expectations Module 1:

A. Quality Control vs. Quality Assurance B. Good Laboratory Documentation

Jan 17

Jan. 16 Module 2: Quality Systems/Quality Assurance

A. Key Elements B. QSIT

Jan. 24

Jan. 23 Module 3: EP/BP/JP/USP, Use and Certification of Performance

Jan. 31

Jan. 30 Project Assignments will be issued Module 4: Method Development and Validation

Feb. 7

Feb. 6 Module 5: Laboratory Investigations

A. Identifying Compliance Concerns B. Investigating OOS Results

Feb. 14

Feb. 13 Teleconference 2: 9 – 11 am Module 6: ASTM Methods

Feb. 21

Feb. 20 Module 7: Technical Requirements

A. Training B. Credentials/Professional skills

Feb. 28

March 1 is midpoint of the semester

Feb. 27 Module 8: Working in a cGMP Environment Mar. 6

Mar. 5 Module 9: Lab and Facility Audits Mar. 13

Mar. 12

Teleconference 3: 9 – 11 am Module 10: Preventative Maintenance, Calibration, Certification

Mar. 20

Mar. 19 Module 11: Typical QC statistical tools Mar. 27

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Saturday Topic Assignment or

Assessment due

Mar. 26

Module 12: Process Control A. Equipment Qualification / Process Validation B. PAT C. Pharmaceuticals, Biologicals & Nutraceuticals

Apr. 3

Apr. 2 Module 13: Process Deviations and Investigations (Apr. 10)

Apr. 9 Teleconference 4: 9 – 11 am Module 14: Change Control

Apr. 17

Apr. 16 Module 15: CAPA systems Module 16: Facilities and Utilities Qualification Module 17: Quality of the Future

Apr. 24

Apr. 26 Final Research Paper due at 11:59 pm Apr. 26

Apr 28 Presentations files due via eLC Apr 28

May 2 Classes End

May 2 Recording Presentations – All students via Blackboard Collaborate Classroom in eLC

May 2

Exam Week – Review student projects & recordings

Table 3: PHAR 6100 Course Calendar and Outline

= Conference calls to go over the preceding topics. = Dial 1-877-211-7530.

When prompted, enter Guest Speaker Code 6100. For international participants, you will need the caller will dial the exit code for that country + 1 + the pilot number (323-210-1577 or 631-618-9002) followed by the conference number. Exit codes and the full dial string can be found here: http://www.countrycallingcodes.com/. Then, the caller will be prompted to enter the AccessLine number of 877-211-7530 and then the Guest Code of 6100. Remember, all times listed here are in the Eastern Time Zone of the United States. Other important dates: 1) Jan. 15 is the last day to drop/add a graduate course. 2) Jan 18th all UGA Offices are closed. 3) March 22 is the deadline for withdrawal.

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Conference Announcements

FDA/UGA International cGMP Conference Announcement

This conference is co-sponsored by the FDA and the UGA College of Pharmacy. This conference is focused on GMP for pharmaceuticals. Many will find this annual conference very informative. Please contact the Regulatory Affairs Program Office for further information and discounts.

Dates: March 7-10, 2016 URL: http://internationalgmp.com/

FDA/UGA Medical Device Conference Announcement

This conference is co-sponsored by the FDA, RAPS, and the UGA College of Pharmacy. This conference is focused on Medical Devices. Many will find this annual conference very informative. Please contact the Regulatory Affairs Program Office for further information and discounts.

Dates: November 2, 2016 URL: http://mdr-con.com/