Pharmaceutical Quality Assurance and Regulatory Affairs Certificate Program

Quality Assurance: The purpose of pharmaceutical quality assurance is to ensure that the medication manufactured will provide the desired effect to the patient. Quality assurance also guarantees that there are no contaminants present and that the medications will meet quality requirements set forth by regulatory authorities such as FDA. This is exactly why anyone involved with quality assurance should receive GMP and quality training.

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:

1. University degree in sciences and
2. 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:

1. University degree in sciences and
2. Strong and practical understanding of the field either through work experience or obtained by pursuing a Certificate in Regulatory affairs

The NAI QA certification aims to help you get your career started in Quality Assurance by building your knowledge, skills, and confidence in a practical and applied manner in the areas of importance in the QA field:

• 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.

The NAI RA certification aims to help you get your career started in regulatory affairs by building your knowledge, skills, and confidence in a practical and applied manner in the areas of importance in the RA field:

• 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.