Why Quality Assurance and Regulatory Affairs Certificate Program
The Program is intended for individuals interested in working in pharmaceutical and allied industries specifically in the quality assurance and/or regulatory affairs department.
At the end of this program, students will have a practical understanding of, the regulatory and compliance framework around pharmaceutical product development, regulatory submissions, current Good Manufacturing Practices (cGMP), quality concepts, auditing, and technical writing techniques.
Students will benefit from an applied and practical approach to Quality Assurance and Regulatory Affairs training which is complimented by hands-on projects. Apart from using the experience and knowledge gained directly in their professional careers, individuals who are, also, interested in the Regulatory Affairs Certification (RAC) Drugs exam or quality assurance- related ASQ certifications, can use this program as a preparation tool for their exams.
In this Program
The program provides knowledge and insight into the current US Pharmaceutical Quality Assurance and Regulatory Affair standards and regulations for all drug product types including prescription and over-the-counter drugs, biologics, medical devices, as well as combination products.
Quality Assurance and Compliance topics such as US-FDA and various global regulations and guidelines, current Good Manufacturing Practices (cGMP), ICH quality guidelines as well as Quality Assurance systems such as stability, validation, change control, CAPA and SOPs are discussed in detail.
Regulatory Affairs topics such as submission strategies, IND, NDA and ANDA, promotion, packaging, labelling, patents, and exclusivity as well as an introduction to International Regulatory Affairs are an integral part of the program curriculum. The program provides an in-depth knowledge and understanding of the Quality Standards for the Pharmaceutical industry as well as technical writing and auditing methodologies.
- Interpret cGMP regulations and guidance documents to ensure compliance with US FDA and other applicable global regulations
- Write SOPs, Work Instructions and Validation Protocols
- Knowledge of Change Control, Deviation, OOS, CAPA, RCA reports and templates
- Knowledge of inspections, audits and related reports and responses
- Knowledge of Manufacturing Documents, Annual Product Review reports and Quality Manuals
- Review and analyze a Certificate of Analysis
- Ensure compliance through development, implementation, and monitoring of Quality Management System
- Ensure documentation according to Good Documentation Practices and Data Integrity Principles
- Identify errors or discrepancies on GMP quality and manufacturing documents and provide resolutions
- Understanding of CAPA
- Knowledge of regulatory submissions – IND, NDA, and ANDA
- Working knowledge with CTD
- Ensure adequate completion of all pre-marketing and post-marketing submission related documents for:
- Drugs
- Biologics
- Medical devices and In Vitro Diagnostics
- Combination products
- Advise on special regulatory streams and patents to expedite review and gain sponsor benefits
- Organize submission documents effectively
- Use effectively electronic tools such as regulatory databases, and Electronic Submission Gateway.
- Manage post-approval safety information as well as reporting activities
- Work effectively and collaboratively with members of the quality assurance and regulatory affairs departments on a domestic and/or international level to promote progress and ensure compliance
- Work with members of the marketing department to ensure labeling and promotional activities compliance
- Ensure Continuous Improvement and Production Control
Level 1
- QA101 Introduction to the Pharmaceutical Industry
- QA102 current Good Manufacturing Practices – GMP – Quality Systems – Part 1
- QA103 Introduction to Pharmaceutical Manufacturing Methods
- QA203 Good Documentation – Data Integrity
- RA102 Introduction to Regulatory Pathways for Drugs, Biologics, Devices, Combination Products and Dietary Supplements
- RA106 Prescription and Over-The-Counter Drug Product Submissions, Patents and Exclusivity
- RA203 Clinical Trials, GCPs and Clinical Submissions for Drugs, Biologics and Medical Devices
- IP-QARA-1 Project One – Case Study on Data Integrity
- IP-QARA-2 Project Two – Orphan Drug Designation Request Form Submission
Level 2
- QA201 Introduction to Quality Documents and Technical Writing
- QA202 current Good Manufacturing Practices – GMP – Quality Systems – Part 2
- QA204 Introduction to Auditing
- RA202 Drug Product Labeling, Advertising and Promotion
- RA204 Canadian Regulatory Submissions
- RA206 Chemistry, Manufacturing and Control
- RA208 Post-Approval Submissions and Compliance: Prescription Drugs and Biologics
- RA308 European Regulatory Submissions
- IP-QARA-3 Project Three – Stability Review
- IP-QARA-4 Project Four – Prescription Drug Labeling Submission
Level 3
- QA301 Quality Documents and Technical Writing – Advanced
- QA302 current Good Manufacturing Practices – GMP – Quality Systems – Part 3
- QA304 Advanced Pharmaceutical Auditing
- RA302 Biologics and Biosimilars Submissions, Compliance, Labeling, Advertising and Promotion
- RA303 Medical Devices
- RA304 Pharmacovigilance and Risk Management
- RA305 Generic Drugs Submission
- RA306 International Regulatory Submissions (except Canada, U.S., Europe)
- IP-QARA-5 Project Five – FDA 483 Response Letter
- IP-QARA-6 Project Six – Medical Device License Submission
What is the job outlook and market demand for Quality Assurance & Regulatory Affairs professionals?
An important economic and societal presence, the pharmaceutical sector develops, manufactures, and sells a virtual medicine cabinet stocked with prescription and over-the-counter drugs. These drugs cure, treat, and prevent all sorts of conditions, ranging from cancer, high cholesterol, and colds to diabetes, Alzheimer’s disease, and allergies. Pharma employees and employers alike make a difference in millions of Americans’ lives, elevating the attractiveness of major pharmaceuticals as a good career path.
Quality assurance and/or Regulatory Affairs professional plays a crucial role throughout the product/drug life cycle from research and design to manufacturing, distribution and sales. It serves to ensure patient safety and the efficacy of the product and without it, a product will not reach the market. Recently, there has been a notable increase in demand for quality assurance and regulatory affairs jobs within the pharmaceutical, biopharmaceutical, and medical device companies.
- Quality Assurance Scientist
- Quality Assurance Associate
- Regulatory Affairs Specialist
- Regulatory Affairs Project Manager
- Regulatory Affairs Project Coordinator
- Regulatory Affairs Manager
- Regulatory Affairs Director
- Compliance Specialist
- Compliance Associate
- Quality Auditor (GMP)
- Deviation Investigator
- Validation Engineer
- Validation Specialist
- Stability Specialist
- Stability Associate
- Change Control Associate
- Qualified Person
What do Pharma and Allied Industries (e.g. Biopharma and Medical Devices) professionals earn?
Quality Assurance professionals’ average compensation continues to increase, according to the ZipRecruiter, the majority of Pharmaceutical QA salaries currently range between $50,000 (25th percentile) to $86,000 (75th percentile) with top earners (90th percentile) making $105,000 annually across the United States. The average pay range for a Pharmaceutical QA varies greatly, which suggests there may be many opportunities for advancement and increased pay based on skill level, location, and years of experience. Regulatory professionals’ average compensation continues to increase, according to RAPS’ recent compensation survey. The average total compensation for US-based regulatory professionals in recent years ranged from $292,625 for vice presidents to $108,627 for specialists. Respondents reported an average base salary increase of 5.6% from year to year.Quality Assurance and Regulatory Affairs for Pharma, Biopharma, Medical Devices, and Allied Industries
Quality Assurance is process-oriented and focuses on eliminating all process variation by creating, revising, and strictly implementing a set of tightly and precisely defined processes and procedures that when exactly followed, ensure the final quality of the product.
Quality Assurance is preventative by nature.
It is important to note that Quality Assurance is not concerned with the measurement or inspection of that finished product – that is the role of Quality Control.
Instead, Quality Assurance focuses on areas such as monitoring and inspection of the methods used in production processes, documenting procedures, conducting audits, and creating and implementing, process checklists, process standards, and standard operating procedures (SOPs).
Regulatory affairs professionals: play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry. The Regulatory Affairs department is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of the development of new medicine and in the post-marketing activities with authorized medicinal products. Regulatory affairs in many cases form the link between pharmaceutical companies and regulatory authorities, such as Food and Drugs Agency (FDA). At the company, they interact with the Research and Development (R&D), quality, compliance, and manufacturing staff to communicate their interpretation of federal and local guidelines.
- Prepare and/or review quality policies and procedures in compliance with Good Manufacturing Practices (cGMP)
- Auditing the production processes to ensure both internal and external regulations and standards are being adhered to
- Ensuring auditing and manufacturing documentation are kept up to date.
- Train production staff on quality procedures, protocols, and documentation such as master manufacturing documents, standard operating procedures (SOPs), change controls, and non-conformities.
- Train and provide assistance to less experienced members of the QA team on quality procedures, protocols, and documentation
- Maintain Quality Assurance documentation such as SOPs.
- Investigate measurements that are found to deviate from standards
- Write Standard Operating Procedures (SOPs)
- Review, approve and communicate root cause and corrective action to stakeholders (RCA and CAPA)
- Review complaints and adverse events
- Coordinate investigation of quality issues with customers and suppliers
- In the pharma and med device industry, review cGMP and other GxP documents to ensure company processes comply
- Prepare and/or review regulatory submissions to support clinical trial and marketing authorization activities.
- Provide high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, and Labelling documents.
- Regulatory filings in emerging markets.
- Assist in the development of high-quality dossiers for various markets
- Review and Gap Analysis of Technical Documentation for Non-CTD/CTD dossier compilation.
- Work with the cross-functional team & review additional data generated in response to review comments per country.
- Compile Dossiers.
- Review the registration dossier (m1-m5) as per country-specific regulatory requirements etc.
Knowledge and insight into the current U.S. and global Professional quality regulations and guidelines for prescription and over-the-counter drugs, biologics, biosimilars, medical devices, as well as combination products.
Knowledge of topics such as GMP, GxP, validation, change control, stability, non-conformities, auditing, root cause analysis (RCA) and corrective and preventative actions (CAPA), standard operating procedures (SOPs) and compliance is a must for an aspiring quality assurance professional. Additionally, you would need strong communication and leadership skills, as well as analytical thinking, problem-solving, and attention to detail.
Knowledge and insight into the current U.S. and global Professional Regulatory Affairs pathways for prescription and over-the-counter drugs, biologics, biosimilars, medical devices, as well as combination products. Knowledge of topics such as promotion, packaging, labeling, patents, CMC, CTD, NDA, ANDA, GMP, and post-approval submissions and compliance is a must for an aspiring regulatory affair professional. Additionally, you would need strong communication and leadership skills, as well as analytical thinking and problem-solving. Either during the development of regulatory strategies or presentations to stakeholders, these skills along with strong industry knowledge will be needed to excel.
This is a critical position within a company that requires monitoring trends and enforcing regulations for products and services to be sold.
Quality Assurance professionals’ average compensation continues to increase, according to the ZipRecruiter, the majority of Pharmaceutical QA salaries currently range between $50,000 (25th percentile) to $86,000 (75th percentile) with top earners (90th percentile) making $105,000 annually across the United States. The average pay range for a Pharmaceutical QA varies greatly, which suggests there may be many opportunities for advancement and increased pay based on skill level, location, and years of experience.
Regulatory professionals’ average compensation continues to increase, according to RAPS’ recent compensation survey. The average total compensation for US-based regulatory professionals in recent years ranged from $292,625 for vice presidents to $108,627 for specialists. Respondents reported an average base salary increase of 5.6% from year to year.
Successful quality professionals typically have cross-functional training in areas such as science, pharmacy, and engineering. In some cases, the quality assurance professionals worked first in related departments, such as administration, research and development, manufacturing, clinical research, lab sciences, pharmacology, and engineering. However, in general, quality assurance professionals have the following:
- University degree in sciences and
- Strong and practical understanding of the field either through work experience or obtained by pursuing a Certificate in Quality Assurance.
There is no degree or career trajectory that promises success in the field. Successful regulatory affairs professionals typically have cross-functional training in areas such as science, pharmacy, engineering, marketing, and business. In some cases, the regulatory affairs professionals worked first in related industries, such as quality assurance and quality control, research and development, manufacturing, clinical research, lab sciences, pharmacology, and engineering. However, in general, regulatory affairs professionals have the following:
- University degree in sciences and
- Strong and practical understanding of the field either through work experience or obtained by pursuing a Certificate in Regulatory affairs – (hyperlink it to NAI RA page) contact us at
- GMP and GxP for Drugs, OTC, Medical Devices and combination products, Biologics and Biosimilars
- GMP and CMC knowledge and experience
- FDA and related global regulations and guidelines
- Auditing and inspections
- In addition to the requirements outlined above, you will also need to have a deeper understanding of Quality Risk Management and be familiar with Validation and Equipment Validation Protocols.
The certification builds your knowledge and indicates to the employer your level of motivation and interest in the industry as well as a documented proof of your knowledge. After the completion of the certification, you can confidently showcase your QA skills on your resume and elaborate on them in an interview.
- Medical Devices and combination products
- Biologics and Biosimilars
- NDA and ANDA filings
- GMP, CMC, and CTD knowledge and experience
- Pharmacovigilance and post-market surveillance
- Labelling and advertising
- Prescription and over-the-counter drug products submission
- Patents and exclusivity
The certification builds your knowledge and indicates to the employer your level of motivation and interest in the industry as well as a documented proof of your knowledge. After the completion of the certification, you can confidently showcase your RA skills on your resume and elaborate on them in an interview.
The certification builds your knowledge and indicates to the employer your level of motivation and interest in the industry as well as a documented proof of your knowledge. After the completion of the certification, you can confidently showcase your QA or RA skills on your resume and elaborate on them in an interview.
Our student services department works with you one on one to help navigate the job application process including the building of your resume, preparing for an interview, and connecting you to the industry.
You don’t have to complete the entire program. Each module will lead to its own certificate.
Our admission counselors can help you do a skill gap analysis to pick the appropriate course depending on your level of expertise.
No, you can extend the program end date for up to 72 weeks. Please contact our admin team for more information at info@neuageinstitute.com.
General
Individual Modules: On the page of any given course, fill in the form with your full name, email address, and phone number and check off “Agree to the Terms and Conditions of Use for NAI Online learning”. Once the form is filled out, you can click on REGISTER ONLINE to pay for the course. After payment is authorized, a link to the course, along with your log-in information, will be sent to you via email from our Online Learning team. Access to each course will be restricted after 4 weeks.
NAI online delivery is self-paced. Self-Paced Online (SPO) classes are entirely online courses that allow students to set their schedule as they move through the content at their own pace within an expected course completion deadline. Students log into their accounts to view their course syllabus and instructions on how to complete lessons, assignments, and exams. SPO courses are a flexible option for students with busy schedules, family responsibilities, and/or work obligations.
NAI courses are best for self-directed learners who can determine the amount of time needed to master the material provided in each module. Instructors provide valuable feedback on coursework and are available to provide additional instruction as needed when prompted by the student. While student-initiated communication is not mandatory, students are required to schedule a mid-term check-in with their instructor either by phone or video conference meeting.
There are regular pre-scheduled instructor-led review classes that are available to the online student to provide them with a better understanding of the concepts and to guide and answer any questions that students have.
Technical: You can reach our support team at onlinelearning@neuageinstitute.com Mon-Fri between 9am-5pm EST at 862-842-4200.
A computer or mobile device with audio and internet access is required. The ability to view various document formats including PDF, Word and PowerPoint files is also required. We recommend using Google Chrome as the default browser for online learning with NAI.
NAI Online uses a combination of BrightSpace learning platform with Storyline 360, videos and PowerPoint to present class material. Most material is also provided as downloadable and printable PDFs.
Online courses use a combination of quizzes and exams, and project work which are submitted via our online training platform – BrightSpace. Questions may be in the format of multiple choice, true/false, fill in the blanks, short answers. Each course is unique and utilizes the best assessment tools for that material.
Certificate Programs: After successfully completing all courses within a program, our online learning coordinator will contact you to arrange for the delivery of your final certificate and report card.
Self-funded Students
You may take term(s) off at any time. Please note, once you have started a term, you must complete the modules assigned to you during that term. If you need to take a break from your studies in the middle of the term due to unforeseen circumstances, you must consult with an NAI Online administrator for options.
Students on government or other financial assistance
You are required to strictly adhere to the start and end date specified on your financial aid application and as such you are not able to take any unscheduled break. You might be able to take more modules in a given term and have a lighter course load in the subsequent terms. Please contact us at 862-842-4200 or onlinelearning@neuageinstitute.com.
For full-time studies, learners can expect to spend about 20 hours per week towards their studies. For the full schedule of each program, refer to the online term table.
Please refer to the financial aid section of the website
Yes – we offer a flexible payment schedule for all online students. Contact us at onlinelearning@neuageinstitute.com to find out more about payment plans with NAI.
Yes, in general students move through levels. Each level must be completed prior to proceeding to the next level. Please review your program outline or contact us at onlinelearning@neuageinstitute.com for more information.
36 Weeks
Duration
Online
Mode of Delivery
May 13, 2024
Start Date
OUR STUDENTS WORK AT
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