Home > Information for Academic Credit Programs > Certificate in Regulatory Affairs in a Technical Environment
Certificate in Regulatory Affairs in a
Technical Environment
Today it is essential that employees in the pharmaceutical, biotech, and medical device manufacturing companies – or related fields – understand the regulatory environment in which they work. Whether it’s for better performance or career development, employees in these industries need to know how and why their products make it to the marketplace – or how and why they get rejected. What is the FDA? How does it operate? What are the regulations and FDA requirements that must be met in order to manufacture and market a drug or a vaccine…a medical device? What is the process and timetable, and what are the strategies that can be used to get a product to market in the least amount of time? …your patent is expiring—tick, tick, tick. Finally, what are the risks and costs of non-compliance? (Hint – they’re huge!)
Regulatory Affairs is a technical subject. Your background in chemistry or chemical engineering will help you write the FDA-required protocols on pilot plant operations, on quality control procedures, or on impurity profiles of drug substances.
This master’s-level certificate program has been developed for employees working in pharmaceutical, biotech, and medical device manufacturing companies and dealing with regulatory and FDA issues in the workplace, those in the legal profession working with FDA law and regulations, and others interested in the field. Students will gain a general understanding of the Regulatory Affairs environment, a broader understanding of the FDA and how it works, an understanding of FDA requirements covering the manufacture of drugs and vaccines, the risks and costs of non-compliance, and an understanding of the process, timetable and strategies used to get a product to market.
Available in a certificate program format and now entirely online (interactive satellite broadcast of courses will be scheduled occasionally for participation at LESN partner sites), Lehigh University provides you with the tools you need to be successful with our Certificate in Regulatory Affairs in a Technical Environment.
Courses
Four courses (12 credits for credit participation) are required to complete this certificate and students will take any four of the following for certificate completion (courses may be taken in any order, subject to scheduling)
- Chemistry 425 Regulatory Affairs I – Discovery to Approval
- Chemistry 428 Regulatory Affairs II – Biomarkers
- Chemistry 442 Regulatory Affairs III: Validation of Analytical Assays
- Chemistry 463 Pharmaceutical Regulatory Affairs IV – Commercial Production, Validation, and Process Qualification
- Chemistry 474 Regulatory Affairs V - Pharmaceutics
Additional Notes about the Required Courses:
- Students may begin the courses at the start of any semester period – Summer/Fall/Spring.
- Course are offered in a semester-based timeframe.
- There is no residency requirement
- Recommended background: Students should possess a background in principles of analytical chemistry, two semesters of organic chemistry, and one semester of biochemistry
- Students taking courses for credit are responsible for arranging for an independent proctor for examinations. Proctoring may be done by an employee of an academic institution or library, or by HR or other company official. The proctor may not be related to or affiliated with the student in any way. Proctoring eligibility will be verified by Lehigh’s Office of Distance Education.
This certificate program is available either for Credit or Professional Continuing Education participation. Choose the learning option you prefer based on your career needs and academic goals. Lehigh University’s commitment to academic excellence ensures your education experience will prepare you for the challenges you face in today’s dynamic work environment.
Learning Options
Credit Participation: All courses offered may be taken for Lehigh academic credit only by students admitted to Lehigh University.
- Prospective students wishing to pursue this certificate for credit will apply for Non-Degree admission that is intended for applicants wishing to take up to twelve credit hours of graduate-level study without seeking a degree.
- Upon successful completion of the required courses, students will receive a Certificate of Completion and the courses will be listed on an official Lehigh University transcript.
- Credit Program Advisor: Professor Rebecca Miller, (610) 758-3676, or e-mail: rsm4@lehigh.edu.
Completed Certificate to Master’s Degree:
M.S. in Chemistry – For students wishing to continue and complete requirements for an M.S. in Chemistry (online and satellite programs), all courses listed for the certificate may be applied toward requirements for the degree-track program*.
*Students must complete additional degree-track admission requirements and have successfully completed the courses in the certificate with grades of B- or higher. In addition, the program advisor will conduct a phone interview with the prospective student to determine student’s academic preparedness and to ensure student has sufficient background courses/knowledge to be successful in a degree-track program. Acceptance into a degree program is not guaranteed and applicants must meet all admissions standards and requirements.
Professional Continuing Education (PCE): For students wishing to pursue this certificate for non-credit (professional continuing education). After completion of four required courses, participants will be issued a Certificate of Completion.
PCE registrants:
- Are not matriculated at Lehigh University
- Do not submit work for evaluation
- Do not receive Lehigh University credits in any form
- Do not generate a Lehigh University transcript
- Will receive a Certificate of Completion
PCE participation simply requires completion and submission of the LESN-Online Professional Continuing Education Registration and Payment form.
Delivery Systems
For credit or professional continuing education participation, this program may be taken either by live and interactive satellite broadcast (when available at LESN partner sites) or in entirety in an asynchronous online format (LESN-Online).
Satellite provides broadcasts of real-time campus classes to students at LESN partner sites.
Online provides programming over the Internet using streaming video technologies, so students watch actual class videos plus course graphics (slides, charts, etc.) These courses are available for anytime/anywhere access using home or office computer with a broadband Internet connection.
For a detailed description of our delivery systems, please refer to the delivery methods page.
Course Descriptions:(Four courses required for certificate completion)
Chemistry 425 (3 credits)/CH-OL425 (professional continuing education) Pharmaceutical Regulatory Affairs I – Discovery to Approval
This course covers the stages of the drug approval process and how these relate to the laboratory activities that provide the scientific basis for the New Drug Application (NDA). Lectures treat drug discovery, chemical process development of the active pharmaceutical ingredient (API), and pharmaceutical process development of the drug product. Regulatory issues in screening and testing, the management of the preclinical trials, and the management of clinical trials will be covered. The regulatory requirements for the production of the drug substance (API) from bench to pilot plant to full-scale manufacturing will also be covered. Included in the discussions will be Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). The regulatory issues concerning the use of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) are also covered as well as the processes for approvals of diagnostics and devices. All topics are presented by practicing professionals in the regulatory affairs area.
Chemistry 428 (3 credits)/CH-OL428 (professional continuing education) Pharmaceutical Regulatory Affairs II –Biomarkers for Pharmaceutics and Diagnostics: Laws & Regulations (3)
Regulations have set in motion the use of Biomarkers as a key element for pharmaceutical development. Biomarkers will become a method to demonstrate safety and efficacy of experimental drugs during human trials. This course will review the history of Biomarker and Medical Device law/regulations in the United States. It will also define the current scientific requirements for Biomarkers to meet new regulations. Case studies will provide examples for the use of Biomarkers in pharmaceutical development.
Chemistry 442 (3 credits)/CH-OL442 (professional continuing education) Pharmaceutical Regulatory Affairs III – Validation of Analytical Assays
This course will cover topics such as Introduction to Analytical Terms and Concepts, Regulations for Pharmaceutical Analytical Laboratories (both Food and Drug Administration and the International Conference on Harmonization), Setting and Evaluating Instrument Performance Criteria, Instrument Acceptance, and Assay Design and Validation. Specific examples for assay design and validation, especially for HPLC are given. (Prerequisite: students should possess a background in principles of analytical chemistry plus one semester of organic chemistry or permission of the instructor)
Chemistry 463 (3 credits)/CH-OL463 (professional continuing education) Pharmaceutical Regulatory Affairs IV – Commercial Production, Validation, and Process Qualification
The University’s Certificate Program in Pharmaceutical Affairs has prepared students to understand applicable regulations for the discovery, development and analysis of pharmaceuticals and medical devices. This course will address the last portion of successful commercialization. The focus of the course will be the review and application of regulations and strategies related to the manufacture of pharmaceutical and combination medical device products. Underlying regulations and principles will be followed by examples and problem solving. Students will cover the following topics from the text. Additionally they will use knowledge gained from lectures to trouble shoot problems from hypothetical situations confronted by a team trying to manufacture and scale up a new product. Lecture topics from the text will include:
- Introduction: Status and Applicability of US Regulations/EU Guidelines—General Quality Issues.
- Personnel, Organization, and Training
- Premises/Buildings and Facilities
- Contamination and Contamination Control
- Equipment
- Materials Control
- Production and Process Controls
- Packaging and Labeling Control
- Holding and Distribution
- Laboratory Control
- Records and Reports
- Returned and Salvaged Drug Products
- Sterile Products Manufacture—Basic Principles
- GMP and Quality Assurance in Sterile Products Manufacture
- Validation—General Principles
- Validation---Applications
- Self-Inspection and Quality Audit
- US cGMPs and EC GMP Guide --- Concluding Comparison
Chemistry 474 (3 credits)/CH-OL474 (professional continuing education) Pharmaceutical Regulatory Affairs V – Introduction to Pharmaceutics
There is a saying in medicinal chemistry circles that “a clever crew in the pharmaceutics group can buy you two logs on the clinical potency of your lead compound.” How a drug substance is formulated, how it is stabilized, how it is delivered, and how it is released for systemic availability, are key factors in whether you have a marketing success or just one more dead (but once promising) therapeutic candidate. It is often true that the IC50 – and the apparent clinical dose – of the best drug substance leaving the synthetic organizers’ hands, can be improved by pharmaceutical optimization. This course is taught from an applications perspective by practitioners in the field and covers the analytical and physical chemistry of drug development.
Delivery Systems
For credit or professional continuing education participation, this program may be taken either by live and interactive satellite broadcast (when available at LESN partner sites) or in entirety in an asynchronous online format (LESN-Online).
Satellite provides broadcasts of real-time campus classes to students at LESN partner sites.
Online provides programming over the Internet using streaming video technologies, so students watch actual class videos plus course graphics (slides, charts, etc.) These courses are available for anytime/anywhere access using home or office computer with a broadband Internet connection.
For a detailed description of our delivery systems, please refer to the delivery methods page.