Introduction
Who should attend
Why QARA Program
Learning Features
Related Courses
About QARA
The pharmaceutical and biopharmaceutical industries are governed by strict regulatory frameworks and demand robust quality systems. To meet the growing industry need for professionals skilled in both Quality Assurance (QA) and Regulatory Affairs (RA), Royed Training offers a unique 1-Year Online Dual Specialization PG Certification Course — PGQAR, also popularly termed as QARA program. This comprehensive program is designed to equip learners with a deep understanding of global quality systems and regulatory compliance strategies across the product lifecycle.
Whether you’re a recent graduate or a working professional, this self-paced, industry-oriented program enables you to master quality assurance regulatory affairs principles and apply them directly in real-world scenarios through simulations, case studies, and interactive learning modules.
Course provides 1000s of prebuilt SOPs in open format which give users to understand overall quality documentation for plant management.
This comprehensive Quality Assurance and Regulatory Affairs course begins by offering an in-depth understanding of quality documentation principles, regulatory frameworks, and industry best practices tailored to the pharmaceutical and medical device sectors.
Furthermore, it emphasizes hands-on practical training in drafting, managing, and controlling essential documentation to maintain compliance and uphold product quality.
As a result, participants will acquire the critical knowledge and skills needed to navigate the complexities of quality management systems in a regulated environment.
Ultimately, this course equips learners to become highly valuable assets within pharmaceutical and medical device companies, regulatory bodies, and related organizations.
QARA Course Snapshots
- Course Code: RYD-130
- Title of the course: PG Certification in Quality Assurance Documentation (PGQAD)
- Nature of the course: Online distance learning course. Hence, this course can be accessed online across anywhere 24×7. Moreover, you can attend the course at your convenience in your flexible time. For example, you want to attend the session at your 11 pm at night, you can do that.
- Duration of the course: 1 Year
- Eligibility: Graduation in any discipline.
- Course Certification: Certificate will be provided at the end of the successful completion of the course.
Who should attend this
Quality Assurance Regulatory Affairs Course?Â
- Quality Assurance/Quality Control Professionals.
- Regulatory Affairs Specialists.
- Compliance Officers.
- Manufacturing and Production Managers.
- Research and Development Teams.
- Anyone involved in pharmaceutical and medical device documentation and compliance.
Why Quality Assurance Regulatory Affairs Course (QARA Program)?
In today’s highly regulated pharmaceutical landscape, professionals with combined expertise in Quality Assurance and Regulatory Affairs are not just valuable — they are essential. PGQARA is a unique program. Let’s find the uniqueness of the QARA dual specialization course.
-
Dual Expertise in One Program: Acquire skills in both Quality Assurance and Regulatory Affairs – two of the most in-demand functions in pharma, biotech, and medical device sectors.
-
Industry-Relevant Curriculum: Developed by regulatory and quality experts, the course blends theoretical knowledge with practical insights aligned with current global guidelines (ICH, FDA, EMA, WHO, etc.).
-
Career-Advancing Qualification: This PG certification opens doors to specialized roles like Regulatory Affairs Executive, Quality Compliance Manager, QA/QC Analyst, and Global Regulatory Specialist.
-
Case-Based and Practical Approach: Real-life regulatory submissions, audit scenarios, and quality management system (QMS) case studies make the training highly experiential. This case studies helps to learn about the quality assurance documentation decision making in case-to-case scenarios. Hence, participants will develop practical job-related competency.
-
Global Regulatory understanding: The course supports knowledge of region-specific regulatory frameworks (US, EU, India, GCC, ASEAN, etc.) preparing you for global career opportunities.
- QA Documents and SOPs: Course provides 1000s of case studies and prebuilt SOPs in open format which give user to understand overall quality documentation for plant management.
Learning Features of Quality Assurance Regulatory Affairs Course:
- To begin with, enjoy self-paced 1-year online learning, offering the flexibility to learn anytime, anywhere.
- In addition, benefit from e-lectures featuring video-based explanations, downloadable resources, and self-assessment tests.
- Moreover, access downloadable study modules that serve as easy reference materials for future use.
- To reinforce learning, concept checkers and quizzes are integrated throughout the course for regular assessments.
- Furthermore, engage in simulations and real-life scenarios to apply your knowledge in practical, job-relevant situations.
- With the help of a course tracking dashboard, monitor your learning progress and performance analytics at every step.
- Upon completion, earn a dual specialization certification, evaluated based on your performance.
- Notably, the course includes job skill mapping, ensuring direct alignment with QA and RA professional roles.
- Throughout the course period, enjoy free updates to stay current with regulatory and quality trends.
- For added convenience, the platform is mobile-friendly, accessible via desktop, tablet, or smartphone.
- Finally, display your achievement with a social share badge, perfect for sharing on LinkedIn and other professional platforms.
Few of the similar courses to Quality Assurance Regulatory Affairs CourseÂ
- Quality Assurance and Documentation
- International Drug Regulatory Affairs
- Drug Biologic Medical Device Regulatory Affairs
- EU MDR Training
- US Pharmaceutical and Biopharmaceutical Regulatory Affairs
- Japan Drug Regulatory Affairs
- Drug Registration and Regulation in China
- Drug Discovery and Development to Commercialization
- European Drug Regulatory Affairs
- Drug Registration and Regulation in GCC countries
- UAE Drug Regulation and Registration
- Drug Registration and Regulation in Saudi Arabia
- Middle East Drug Regulatory Affairs
Quality Assurance (QA)
Quality Assurance is the backbone of pharmaceutical manufacturing and product lifecycle. It encompasses the creation and enforcement of SOPs, compliance with GMP guidelines, and management of deviations, CAPAs, audits, and validation protocols. The course explores:
-
Pharmaceutical Quality Systems (ICH Q10)
-
cGMP Compliance and Audits
-
Data Integrity and Validation Principles
-
Batch Record Review and Release Procedures
-
Change Control and Risk Management
Regulatory Affairs (RA)
Regulatory Affairs professionals ensure that products comply with all regulations and standards before and after they reach the market. The RA portion of this program provides in-depth training on:
-
Regulatory Submission Pathways (US FDA, EMA, CDSCO, GCC, ASEAN, etc.)
-
Dossier Preparation – CTD/eCTD format
-
Drug Master File (DMF) and Site Master File (SMF) Compilation
-
Post-Marketing Surveillance and Pharmacovigilance Basics
-
Product Lifecycle Management and Labeling Compliance
This dual-focused course helps you integrate quality principles with regulatory strategies, preparing you to be a cross-functional asset in any life sciences organization.
Section 1Fundamental of Drug Discovery and Development
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application
Lecture 3New Drug Application (NDA)
Lecture 4Basic concept and understanding of the Generic Drug
Lecture 5Abbreviated New Drug Application (ANDA)
Lecture 6Preformulation Study in Drug DevelopmentÂ
Lecture 7Regulatory Requirements for Preformulation StudyÂ
Lecture 8Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies Â
Lecture 9Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studiesÂ
Lecture 10Types and Timing of Non-clinical StudiesÂ
Lecture 11Exploratory IND Vs. Traditional IND
Lecture 12Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 13Orphan Drug Designation
Lecture 14Review on Drug Discovery and DevelopmentÂ
Lecture 15Understanding on Clinical Trials and Clinical ResearchÂ
Lecture 16Clinical Trial Protocol Writing
Lecture 17Ethics in Clinical Research
Lecture 18Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 19FDA Forms and How to fill the resources
Lecture 20Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 21Chemistry, Manufacturing & ControlsÂ
Lecture 22Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Lecture 23505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 24Advance Learning on 505B2 Pathway
Lecture 25Authorized Generics: Key Understanding
Lecture 26USFDAÂ expedited programs
Lecture 27Complete Response Letter | Key understanding | Management and Action Plan
Lecture 28Introduction to ICH | Members | GuidelinesÂ
Lecture 29ICH Q1 : Stability Guideline | Matrixing | Bracketing
Lecture 30ICH Q2 : Analytical ValidationÂ
Lecture 31ICH Q3 : Impurities
Lecture 32Rest of ICH Q Family Guidelines
Lecture 33Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | FactsheetsÂ
Lecture 34Handling of orange book
Section 2Good Manufacturing Practices
Lecture 35Certification Pharmaceutical Companies / Plants
Lecture 36Premises & Plant Layout Designing
Lecture 37Sanitation and Hygiene
Lecture 38Equipment
Lecture 39Production Modules
Lecture 40GMP Documentation
Lecture 41Quality Control
Lecture 42Handling of Product Complaint
Lecture 43GMP Storage
Lecture 44ISO and ISO Audits
Lecture 45Pharmaceutical SOPs
Lecture 46PDE Value | Importance, Significance | How to calculate PDE valueÂ
Lecture 47Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk ManagementÂ
Lecture 48Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planningÂ
Lecture 49WHO-GMP Certification SchemeÂ
Lecture 50Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP
Section 3 Submission Dossier : CTD | ACTD | DMF - SMF-ANDA | 505(b)(2) | NCE | Petittion| Prior Approval Submission
Lecture 51Introduction to Common Technical Document (CTD)
Lecture 52CMC Dossier & Compliance Management
Lecture 53Electronic Common Technical Document (ECTD)
Lecture 54Advance Practical Training on Dossier Preparation focusing on drug registration in export countriesÂ
Lecture 55Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 56Key Consideration for Drug Master File Preparation and SubmissionÂ
Lecture 57Practical Understanding on Drug Master File Preparation and Submission
Lecture 58Site Master File - Detailed UnderstandingÂ
Lecture 59DMF Completeness Assessment
Lecture 60Drug Master File - Fees
Lecture 61Drug Master File - Global Perspective [Across Different Regions]
Lecture 62Importance of effective dossier management
Lecture 63Common deficiencies in CTD submission dossier
Lecture 64Certificate of Analysis
Lecture 65Detailed Understanding on ANDA Fees
Lecture 66Prior Approval SubmissionÂ
Lecture 67Detailed Understanding on ANDA Fees
Lecture 68Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning
Lecture 69NCE Vs. 505b2 application - Case Based LearningÂ
Lecture 70FTF - 180 Days Exclusivity - Case Based Learning
Lecture 71Classic case study of the 505b2 filing : Case Based Learning
Lecture 72Strategic Planning in Combating 30 months stay strategies of innovator company- Case Based Learning
Lecture 73Climate Zone
Lecture 74Stability Zone Finder
Lecture 75Stability Studies : Case discussions
Lecture 76Stability Data for Zone IV countries
Lecture 77Accelerated and intermediate testing conditions
Lecture 78Long Term Stability Testing Requirements
Lecture 79Stability Study Protocol Development - Dosage form: Capsule
Lecture 80Stability Data Sheet
Lecture 81Dossier Stability Test
Lecture 82Testing Frequency
Lecture 83Bracketing
Lecture 84Matrixing
Lecture 85PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process
Lecture 86Bioequivalence Study | Study design | Different types of BE Studies
Lecture 87Bioequivalence Study | Study design | Parallel Study | Crossover study design | Other alternative study designs | Blood Sampling Planning | Analyte | Bioanalytical Methods Validation | Statistical Model | Ln Transformation | Dose normalisation | Confidence interval acceptance criteria
Lecture 88Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submissionÂ
Lecture 89Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence studyÂ
Lecture 90Bioequivalence Study - Discussion - Dissolution Testing
Lecture 91Bioequivalence Study - Generic Approval and Additives Labeling RequirementsÂ
Lecture 92Introduction to Variation Management | Reasons for Variation | Working in Variation DepartmentÂ
Lecture 93Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.
Lecture 94Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure SystemÂ
Section 4Quality issues, Warning Letter, CAPA and Data Integrity
Lecture 95Data Integrity issues in Pharmaceutical Industry
Lecture 96Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning LetterÂ
Lecture 97Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 98RTQs | Response to Queries | How to handle Regulatory Queries Â
Section 5Biopharmaceutical (Biologics and Biosimilar) Regulations
Lecture 99Introduction of Biologics
Lecture 100Classification of BiopharmaceuticalÂ
Lecture 101Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Lecture 102Differences in Chemical Drug Vs. Biologic Drugs | Key features of Biologic
Lecture 103Principle of Naming of Biologic | Understanding on MAB naming system
Lecture 104Recombinant protein
Lecture 105Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 106Monoclonal Antibodies
Lecture 107Synthetic Immunomodulators
Lecture 108Production of Monoclonal Antibodies
Lecture 109Cytokines
Lecture 110Interferon
Lecture 111Erythropoiesis-stimulating agent
Lecture 112Biological Licensing Application (BLA)Â | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 113Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 114Purple Book: Significance | Searching | Assignments
Lecture 115Vaccine development and approval Process
Lecture 116PDUFA For Biologics
Lecture 117Biosimilar Development Process
Lecture 118Strategic Consideration for Biosimilar DevelopmentÂ
Lecture 119Bio-Manufacturing Process Information
Lecture 120Studies required for approval of biosimilar
Lecture 121Regulatory Requirements for Biosimilar | Stepwise evidence based development | Analytical Similarity | Clinical Study | PKPD study requirements | CMC expectation of Biosimilar
Lecture 122Comparability of Biologics | Different Categories of Comparability | General PrinciplesÂ
Lecture 123CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)
Lecture 124ATMPs | Types and Classification | Regulatory MechanismÂ
Lecture 125mAB - At a glance
Lecture 126ATMPs - at a glance
Lecture 127CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 128Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPsÂ
Section 6European Drug Regulatory Affairs
Lecture 129Introduction to EU RegulationÂ
Lecture 130Orientation to European Countries and National Regulatory Bodies
Lecture 131EU Drug Discovery Development to Commercialization (Step By Step)
Lecture 132Overview of EU RegulationÂ
Lecture 133EMA and EMA Authorisation Process
Lecture 134EU MA Application Types and Strategic Planning
Lecture 135EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National ProcedureÂ
Lecture 136EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application
Lecture 137Validity of the EU MAÂ - Renewal steps, Cessation of the marketing authorisation, Significance of "Placed in Union Market", Suspension or withdrawal & EU MA for licensed products
Lecture 138Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae
Lecture 139EU Orphan Medicinal Products Regulation
Lecture 140Conditional marketing authorisation | Marketing authorisation under exceptional circumstances
Lecture 141Summary of Product CharacteristicsÂ
Lecture 142Compassionate Use
Lecture 143MHRA - UK RegulationÂ
Lecture 144The 'sunset clause' for marketing authorisation of pharmaceuticals
Lecture 145Paediatric use marketing authorisation (PUMA) & Paediatric Investigation Plan (PIP)
Lecture 146EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities &Â Differentiation
Lecture 147EU Prime DesignationÂ
Lecture 148Accelerated assessment by EMEA
Lecture 149EU Adaptive Pathway
Lecture 150European public assessment report (EPAR) - Importance, Component, Management, UpdationÂ
Lecture 151SPOR - Concept of Master Data Management Â
Lecture 152PDE Value : What is PDE value of API? Significance and How PDE value is derived?Â
Section 7References | Discussions
Lecture 153Comparison of Requirement of Various Regulatory Bodies
Lecture 154Comparison of Dossier Requirements of Europe and US
Lecture 155Comparison of DMF requirement of various regulatory bodies
Section 8US MEDICAL DEVICES | Development to Commercialization Cycle
Lecture 156Overview of US Medical Devices Market
Lecture 157Definition of Medical Devices
Lecture 158Classification of Medical Devices
Lecture 159Medical Devices Classification : Work FileÂ
Lecture 160Medical Device Development to Commercialization Process | Understanding Key Stages and respective stage level activities | Important MDR terminologies
Lecture 161How to establish the classification of the medical deviceÂ
Lecture 162FDA Product Code Database : Hands on Training
Lecture 163513(g) Application : Request, User Fees, Review Process
Section 9510K PRE-MARKET NOTIFICATION
Lecture 164510k - Pre-market Notification
Lecture 165Predicate Devices | Substantially Equivalent (SE)
Lecture 166Understanding on 510k | Types of the 510k | Timeline | Difference with PMA
Lecture 167FDA decision making process for different classes of 510k applications
Lecture 168Review Test
Section 10PREMARKET APPROVAL (PMA) APPLICATION
Lecture 169Premarket approval (PMA) application
Lecture 170Differences between 510k VS. PMA
Lecture 171Data Requirements for A Premarket Approval (PMA) application
Lecture 172Data Requirements for A Premarket Approval (PMA) application
Lecture 173PMA Post Submission - Management of CRL - Timeline and Strategic Planning
Lecture 174Labeling Requirement for Medical DevicesÂ
Lecture 175Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements
Lecture 176Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial
Lecture 177Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning
Lecture 178Expedited review of devices
Lecture 179Expiration Dating
Lecture 180Device Master Files
Lecture 181Unapproved use of Medical DevicesÂ
Lecture 182Marketing, Advertising and Promotion of Medical Devices
Lecture 183FDA 513(g)
Lecture 184DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning
Lecture 185Humanitarian Device Exemption (HDE)
Section 11EU Regulation of Medical Devices
Lecture 186EU MDR Classification
Lecture 187EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 188EU MDRÂ | Annexes | Key notes
Lecture 189EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 190EU MDR Guideline | EU MDR - AnnexesÂ
Lecture 191EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chartÂ
Lecture 192EU MDR Authorized Representatives | Mandate | Role and ResponsibilitiesÂ
Lecture 193EU MDR Compliance ProcessÂ
Lecture 194Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special DevicesÂ
Lecture 195Review : DDF DHF DMR MDF DHRÂ
Section 12QMS, Documentation and Dossier Preparation
Lecture 196Medical Device Technical File
Lecture 197Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossierÂ
Lecture 198Quality Management System (QMS) for medical devices companyÂ
Lecture 199Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk ManagementÂ
Lecture 200Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master FileÂ
Lecture 201Medical Device Essential Principle Checklist | Documentation |Â Open file
Lecture 202Implant Card | Regulatory Importance | Content | How to designÂ
Section 13Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contentsÂ
Lecture 203Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contentsÂ
Lecture 204Instruction for Use (IFU) | Design and Development of IFUÂ
Lecture 205UDI | Different Component | How to design Â
Section 14CE Marking
Lecture 206CE Marking | Introduction | Self Certification | General principles of the CE marking | Manufacturer Responsibilities | Third Party Medical Device Manufacturing & CE Marking | Step By Step CE Marking Process
Lecture 207CE- Self Certification
Lecture 208General principles of the CE marking
Lecture 209Manufacturer Responsibilities
Lecture 210Third Party Medical Device Manufacturing & CE Marking
Lecture 211Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 212Few Common Terminologies used in Medical Devices Industry
Lecture 213Step By Step CE Marking Process
Lecture 214Case Study
Section 15ISO 13485
Lecture 215Introduction to ISO 13485 | Importance | Comparison with various other standards
Lecture 216ISO 13485 Documentations | Different Sections | Case StudiesÂ
Lecture 217ISO 13485: 2016 - Different Clauses
Section 16Combination Product Regulatory Affairs
Lecture 218Combination Products Regulatory Affairs | Definition |Â Types | Requirements | cGMP considerations | Risk Management | CAPA
Lecture 219Combination Product RFD Designation Process | Importance | Timeline | Outcome Management
Lecture 220Combination Products Pre-market Approval Process | Lead centers | Concept of Primary Mode of Action | Strategic Submission Pathways
Section 17Medical Device Regulation in India | CDSCO Regulation
Lecture 221Medical Devices Regulation in India | Overall understanding
Lecture 222Regulatory Landscape in India
Lecture 223Classification of the Medical Devices in India | Strategic Planning for the SubmissionÂ
Lecture 224Notified and Non-notified Device | Submission Strategic PlanningÂ
Lecture 225Medical Devices Classification in India - Work Doc
Lecture 226Notified Devices | Registration Process
Lecture 227Medical Device Submission Strategic Pathways | Step by step Process
Lecture 228Medical Device Forms | Purposes
Lecture 229Non Regulatory Medical Devices
Lecture 230Medical Device Voluntary Registration | Documentation | Process
Lecture 231List of Notified Devices | Newly Notified Devices | Significance
Lecture 232List of Notified Bodies with CDSCO
