Quality Assurance (QA) is an essential process in life sciences organizations, regardless of their size. It involves ensuring that products, services, and processes meet specific standards and regulations, and meet the needs and expectations of customers and patients.
QA managers, specialists, and other QA professionals play a vital role in this process. They are responsible for ensuring compliance i.e. making sure that their organization meets current regulations and industry standards, as well as meeting the organization's policies, goals, and objectives.
To perform their duties and be successful in their roles as subject matter experts, they must have a comprehensive understanding of compliance topics that they are responsible for. They also need to gain a broad range of skills, including technical knowledge, problem-solving, project management, leadership, and communication.
The regulations of the US FDA and the EU GMP guidelines require that only qualified personnel are employed in the life sciences industry. At every level of quality assurance, it must be demonstrated that all professionals have undergone the necessary training in GMP.
Many professionals who work in QA roles have previously held positions in a laboratory or have an academic background. Without proper training, these professionals may struggle to adapt to their new position, leading to potential mistakes and setbacks in their work.
In order to acquire the necessary skills and knowledge, QA professionals can take a range of QA courses, and seminars and get certifications to boost their mastery in quality skills to advance their careers.
Certifications are offered by various organizations, including regulators, professional associations, universities, and others.
Would you like to know what QA courses, seminars, and conferences you can do? We've compiled a selection of courses, as well as certifications you can obtain.
Here are some of the most popular programs for QA professionals to consider:
Our selection of courses and certifications
1_Paid online resources
ECA Academy
GMP and GDP Certification Programme
Target learner:
Quality Assurance Managers
Requirements:
Not applicable
Format:
Live online, on demand
Final Exam:
No
Certificate of Completion:
Yes
Accreditation:
by ECA Academy
Recertification required:
Yes, every 2 years
Accreditation:
ECA Certification Programme. To get the certificate, the learner must attend three out of the following courses/conferences. After attending the third course, the applicant obtains the certificate “ECA Certified Quality Assurance Manager.
Program:
There are 15 different programs. One of the programs is the ECA Quality Assurance Manager. To get the certificate, the learner must attend three out of the courses/conferences below. After attending the third course, the applicant obtains the certificate “ECA Certified Quality Assurance Manager”.
- Change Control
- Quality Risk Management (ICH Q9 Training Course)
- The GMP Compliance Manager
- Efficient Batch Record Design and Review
- Complaint Handling and Recalls
- Deviation Management and CAPA
- Quality Oversight
- Quality Culture
- Improve your Quality Reviews
- Lean GMP Systems
- GMP for Beginners
- Pharmaceutical Contracts
- GMP for Medical Devices
- KPIs and Quality Metrics
ASQ
The ASQ Certified Manager of Quality/Organizational Excellence (CMQOE).
Target learner:
Quality Managers who want to be certified
Requirements:
Minimum 10 years of on-the-job experience in one or more of the areas of the program, or minimum 5 years of on-the-job experience in a "decision-making" position.
Format:
e-learning, live-virtual, or face-to-face
Final exam:
Yes
Certificate of completion:
Yes
Accreditation:
This certification program is accredited by ANSI under the ISO 17024 standard
Recertification required:
Yes, every 3 years
Program:
The CMQOE certification is designed for QA professionals who need to learn:
Leadership skills
- Develop and deploy a strategic plan
- Management and communication skills
- Project management methodologies
- Develop and deploy a quality plan
- Quality management standards and performance excellence models
- Quality management tools, assessment, and metrics tools
- Customer-focused vision
- Supply chain management
- Training and development
RAPS e-Learning
RAPS online University Certificates
Target learner:
Regulatory professionals in their first five years in the regulatory field and Quality Assurance Managers
Requirements:
Not applicable
Format:
Online
Final exam:
No
Certificate of completion:
Yes, after completing all the courses of the program selected
Accreditation:
by RAPS
Recertification required:
No
Program:
There are over forty courses to choose from. You can customize your certificate program, so you can specialize in medical devices, and pharmaceuticals, or study both specialties together with the dual certificate program.
ASQ
Six Sigma Green Belt Certification (CSSGB)
Target learner:
Quality candidates who are or have been employed as MBBs within their organization, or well-qualified, Certified Six Sigma Black Belts (CSSBBs) who have substantial experience.
Requirements:
Candidates must have three years of on-the-job experience in one or more areas of the Six Sigma Green Belt Body of Knowledge
Format:
e-learning, live-virtual, or face-to-face
Final exam:
Yes
Certificate of completion:
Yes
Accreditation:
This certification program is accredited by ANSI under the ISO 17024 standard
Recertification required:
No
Program:
The CMQOE certification is designed for QA professionals who need to learn:
- Six-sigma overview: goals, lean principles, and six-sigma methodologies
- Six-sigma phases: define, measure, analyze, improve, control
SGS
ISO 9001:2015 - Quality Management Systems - Auditor/Lead Auditor training course
Target learner:
QA professionals who need to gain the knowledge and skills to perform first, second and third-party audits of quality management systems against ISO 9001.
Requirements:
Learners are expected to have the following prior knowledge:
- Management systems, including the core elements of a management system, the responsibilities of top management, and the Plan, Do, Check, Act (PDCA) cycle.
- The fundamental concepts of a quality management system and the seven quality management principles of ISO 9000.
- The requirements of ISO 9001 and its commonly used quality management terms and definitions.
Format:
Blended course or classroom-based
Final exam:
Yes
Certificate of completion:
Yes
Accreditation:
SGS Approved or CQI/IRCA certified (course certification number 17977-PR238) dependent on location.
Recertification required:
Yes
Program:
The CMQOE certification is designed for QA professionals who need to learn:
- Six-sigma overview: goals, lean principles, and six-sigma methodologies
- Six-sigma phases: define, measure, analyze, improve, control
CQI-IRCA
CQI training certificates in Quality Management
Target learner:
Quality Assurance professionals
Requirements:
Quality Managers who are already working in a quality role who wish to develop their knowledge and skills or Quality Managers looking to advance to a strategic level and aspiring to become a Chartered Quality Professional.
Format:
3 years to complete the courses
Final exam:
Yes
Certificate of completion:
Yes
Accreditation:
By CQI
Recertification required:
No
Program:
There are three types of courses: Foundation, Practitioners, and Professionals. Two training awards are offered: Practitioner Certificate of Quality Management of Professional Certificate of Quality Management.
Practitioner certification covers the following program:
- Process Performance
- Management Systems
- Change and Continual Improvement
- Problem-Solving
- Supply Chains
- Customer Excellence
- Quality Planning
- Managing and Influencing Stakeholders
Professional certification covers leading:
- Enterprise Performance Measurement
- Quality Strategy and Planning
- Business Process Excellence
- Supply Chain Assurance
- Strategic Change and Improvement
- Enterprise Risk Management
GxP Training
Online Quality Assurance Courses
Target learner:
Quality Assurance professionals
Requirements:
Not applicable
Format:
Online, access 24/7 to the course for 12 months at your own rhythm.
Final exam:
Yes
Certificate of completion:
Yes
Accreditation:
CEU (continuing education units) and CPD (continuing professional development)
Recertification required:
No
Program:
There are over 19 QA courses to enroll in. They are accredited compliance and regulatory training sessions designed for life sciences professionals. Some examples are:
- Introduction of Current Good Practices (cGXP)
- Introduction to Pharmaceutical Quality
- Good Documentation Practice (GDocP)
- Good Documentation and Record Retention
- Quality Risk Management
ISPE
ISPE Best of Pharma Series: Quality & Regulatory
Target learner:
Quality Assurance and Regulatory professionals
Requirements:
Not applicable
Format:
Online, access 24/7
Final exam:
Not applicable
Certificate of completion:
Not applicable
Accreditation:
Not applicable
Recertification required:
No
Program:
There are over 78 conference presentations featuring more than 46 hours of content. They offer compelling insights, strategies, and best practices from experts representing global health authorities and leading pharma organizations.
AAMI
Process Validation Requirements & Industry Practices
Target learner:
Professionals in the medical device industry such as R&D Team Members, Quality Engineers, Quality Assurance Managers, Design Engineers, Project/Program Managers, and Process Engineers.
Requirements:
The course is recommended for professionals who already have a basic understanding of the Quality System regulation and have some relevant work experience.
Format:
Live virtual 3-day training
Final exam:
Yes
Certificate of completion:
Yes
Accreditation:
American National Standards Institute (ANSI)
Recertification required:
No
Program:
This 3-day course offers practical tools and techniques for FDA Quality System Regulation process validation and guidance from the Global Harmonization Task Force. It covers planning, protocol development, validation execution, monitoring, control, and re-validation, incorporating industry best practices and real-life examples to align with FDA standards.
13485 Store
Target learner:
Professionals in the medical device industry who are interested in learning about ISO 13485 Quality Management Systems.
Requirements:
Not applicable
Format:
Online, access 24/7
Final exam:
Yes, there is an assessment at the end of each course
Certificate of completion:
Yes, a printable certificate of completion is included
Accreditation:
Depends on the course provider
Recertification required:
No
Program:
The ISO 13485 Store offers over 20 courses focusing on various aspects of ISO 13485 and quality management in the medical device industry. Course topics are comprehensive, catering to a broad range of interests and learning objectives within the field.
Each course includes a reference guide PDF, along with audio and video materials, designed to enhance the learning experience. The time to complete each course varies between 2 to 20+ hours.
Udemy
ISO 9001:2015 Quality Management System auditor
Target learner:
Designed for professionals engaged in quality management within their organizations, including Quality Engineers, QA/QC Specialists, Quality Managers, and those aspiring to become certified QMS Auditors or Implementers.
Requirements:
No previous knowledge is required but familiarity with management systems is useful.
Format:
Online, access 24/7
Final exam:
Yes, there is a quiz to test your knowledge at the end
Certificate of completion:
Yes
Accreditation:
No
Recertification required:
No
Program:
This course offers 5 hours of on-demand video and 5 downloadable resources, guiding you through the implementation and auditing of a Quality Management System per ISO 9001. You will learn:
- The requirements for a Quality Management System according to ISO 9001
- How to implement a Quality Management System and comply to the requirements of ISO 9001:2015
- How to audit a Quality Management System
- Plan, perform, and report QMS audits
- Auditing a management system according to ISO 19011:2018
AAPS
Pharmaceutical Quality Assurance and Quality Control Diploma Program
Target learner:
Professionals seeking comprehensive training for a career in the pharmaceutical industry, particularly in laboratory settings. Ideal candidates include recent graduates and professionals aiming to specialize or advance in pharmaceutical analysis, quality assurance, regulatory affairs, and practical laboratory work within GMP environments.
Requirements:
BSc. (or equivalent) or higher level of education.
Format:
Offers the program in-class in Toronto as well as online and takes 43 weeks to complete.
Final exam:
Yes
Certificate of completion:
Graduates will receive a Post-Graduate Diploma on Pharmaceutical Quality Assurance and Quality Control.
Accreditation:
Accredited as a vocational program under the Private Career Colleges Act, 2005. The program's approval and accreditation come from the Private Career Colleges Branch, which is part of the Ministry of Colleges and Universities.
Recertification required:
No
Program:
This program is meticulously designed to equip students with comprehensive knowledge and practical skills essential for excelling in the fields of Pharmaceutical Analysis, Quality Assurance, and Regulatory Affairs. Delivered by pharma experts, the curriculum ensures that participants receive an in-depth education grounded in real-world applications by working in a cutting-edge laboratory that simulates working in a GMP environment.
Medical Device HQ
Quality management for medical devices and ISO 13485 blended course
Target learner:
It is relevant for people working with QA-related tasks in a medical device organization and those who are typically engaged in supporting QA-related tasks such as CAPA, complaints, risk management, documentation, and internal auditing.
Requirements:
No requirements
Format:
This course consists of two parts:
- The Introduction to Quality Management for Medical Devices and ISO 13485 online course.
- Two half-day live virtual classroom sessions led by an industry expert. During the sessions, you get to apply the theory you have learned via case studies, workshops, and discussions.
Final exam:
Yes
Certificate of completion:
Yes
Accreditation:
Accreditation is in progress.
Recertification required:
No
Program:
This course is specifically tailored to meet the requirements of the ISO 13485
as tangible and concrete as possible, so participants can confidently work in
an organization where ISO 13485 requirements apply. It introduces tools and
methods on how to work successfully and efficiently within a quality
management system.
Topics covered in the course include:
- The regulatory framework,
- The quality management system (QMS),
- Documentation pitfalls,
- Risk-based approach,
- Management responsibility,
- Product realization & traceability.
- A downloadable PDF with text slides and time-saving templates are
included in the blended course.
2_Free online resources
Scilife
Target learner:
Quality Assurance professionals
Requirements:
Not applicable
Format:
Online, free access 24/7
Final Exam:
No
Certificate of Completion:
No
Accreditation:
Scilife
Recertification required:
Yes, every 2 years
Program:
Access is free. You will find a selection of training courses and webinars about quality topics, regulations, guidelines, and methodologies, offered free to Life Science companies that are subscribed to the Scilife Quality platform. For example:
- Smart Quality mindset in your organization
- Smart Quality in Life Sciences (Part I & Part II)
- Quality and Quality Management System
- The QMS pyramid model
- Document control according to ISO 9001
- The management and control of records
- Electronic records and electronic signatures
- How an eQMS/EQMS provides value to your organization
USP
Foundations of Good Manufacturing Practices
Target learner:
Professionals who work in medical products production and quality assurance.
Requirements:
Not applicable
Format:
Online, free access 24/7, each module takes approximately 30-45 minutes to complete
Final exam:
No
Certificate of completion:
No
Accreditation:
USP
Recertification required:
Yes, every 3 years
Program:
This free online course provides an overview of essential GMP principles and requirements. It covers key principles of the WHO and PIC/S standards and will equip participants with a broad, foundational understanding of GMP.
The course includes ten modules on GMP related to:
- Active Pharmaceutical Ingredient (API) production
- Auditing
- Data Integrity and Computer System Validation
- Deviations, Root Cause Analysis (RCA) Tools, and Corrective and Preventive Action (CAPA)
- Finished Dosage Form production
- Heating, Ventilation, and Air Conditioning (HVAC) Systems
- Qualification of facilities, equipment, and utilities
- Quality Risk Management
- Validation
- Water Systems
Coursera
Clinical Trials Data Management and Quality Assurance
Target learner:
Professionals who work in medical products production and quality assurance.
Requirements:
Learners need to have some familiarity with basic scientific, statistical, and management concepts.
Format:
Online, free access
Final exam:
No
Certificate of completion:
Yes
Accreditation:
by Johns Hopkins University
Recertification required:
No
Program:
In this free course, you’ll learn to collect and care for the data gathered during a trial and how to prevent mistakes and errors through quality assurance practices. The expected dedication is 7 hours.
Alison
ISO 9001:2015 Non-conformances and Corrective Actions Explained
Target learner:
Professionals who work in quality assurance and/or quality control, as well as aspiring auditors.
Requirements:
Learners will benefit from having a basic understanding of quality management systems, ISO standards, and the principles of auditing.
Format:
Online, free access 24/7
Final exam:
Yes
Certificate of completion:
Yes, available at an additional charge.
Accreditation:
CPD UK
Recertification required:
No
Program:
This course offers a comprehensive exploration of ISO 9001:2015, including defining objective evidence, clarifying common misconceptions, explaining audit report terminology, and detailing both the basic elements and advanced principles of the standard.
It provides clarity on conducting audits, what auditors look for, and what auditees should expect, making it a crucial resource for anyone looking to enhance their understanding and application of ISO 9001:2015 in quality management. The hours of learning are between 1.5-3 hours.
3 top benefits of online QA courses and certifications
Digitization has brought about significant transformations for both QA managers and professionals in life sciences companies.
The way quality assurance training is conducted has shifted towards being web-based and using social media channels. In order to stay relevant and effectively tackle the changing landscape, employees must continually update their knowledge and skills.
This entails a continuous learning process in which the employees' information-gathering methods must be adjusted to meet their evolving needs. To make this happen, companies must come up with appropriate training opportunities and employees must be willing to partake in them.
E-learning can give your organization the opportunity to monitor employee progress and retain top talent. Online training certificates are worth the time and resources. Here are some benefits of enrolling in e-learning QA courses:
2_Free online resources
Online training courses and certifications for QA professionals can help organizations to uphold quality company standards, improve compliance knowledge, and have an overall quality mindset.
The use of the internet and the intranet makes it easier and easier to learn, communicate, and share knowledge, regardless of time and place.
2_Free online resources
Although the time spent on training certification courses demands effort and resources, QA professionals appreciate the chance to enhance their skills and improve professional growth. As a QA professional, you feel more prepared and motivated to gain confidence. Continuous learning empowers people to improve their skills and competencies within quality excellence.
2_Free online resources
Audits can cause stress and consume a significant amount of time for QA professionals, not to mention the additional costs that may arise if non-compliance issues are uncovered during audits.
Online training and certification programs can ensure QA professionals have completed a comprehensive quality training course and have passed the final exam to demonstrate their competence.
Conclusion: Do QA courses for your organization and your career
Whatever sector of the life sciences industry you work in, quality assurance is increasingly vital. As a QA professional, maybe you need to adapt to new processes or regulations. As a manager, maybe you require your employees to undergo the latest training so that everyone's skills are up to date. And at every level, maybe your organization wants to stay abreast of the most recent innovations in quality.
With continuous learning, people don't only gain relevant knowledge and skills. They are also motivated and empowered to take responsibility for improving quality within your organization.
We outlined for you a range of courses, paid and free, that can aid your development within QA and the life sciences. And We included our very own Scilife Academy training - free if you're subscribed to the Scilife Smart Quality platform. So, good luck with your learning, and if you would like to know more about what Scilife offers, feel free to get in touch.
