Quality Assurance Regulatory Affairs Course [QARA Dual Specialization)

Introduction

Who should attend

Why QARA Program

Learning Features

Related Courses

About QARA

Quality assurance regulatory affairs course by royed training

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?

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 Course

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 Development

Lecture 7Regulatory Requirements for Preformulation Study

Lecture 8Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies

Lecture 9Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies

Lecture 10Types and Timing of Non-clinical Studies

Lecture 11Exploratory IND Vs. Traditional IND

Lecture 13Orphan Drug Designation

Lecture 14Review on Drug Discovery and Development

Lecture 15Understanding on Clinical Trials and Clinical Research

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 & Controls

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 26USFDA expedited programs

Lecture 27Complete Response Letter | Key understanding | Management and Action Plan

Lecture 28Introduction to ICH | Members | Guidelines

Lecture 29ICH Q1 : Stability Guideline | Matrixing | Bracketing

Lecture 30ICH Q2 : Analytical Validation

Lecture 31ICH Q3 : Impurities

Lecture 32Rest of ICH Q Family Guidelines

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 value

Lecture 47Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management

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 planning

Lecture 49WHO-GMP Certification Scheme

Lecture 50Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP

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 countries

Lecture 55Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study

Lecture 56Key Consideration for Drug Master File Preparation and Submission

Lecture 57Practical Understanding on Drug Master File Preparation and Submission

Lecture 58Site Master File - Detailed Understanding

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 Submission

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 Learning

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 88Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission

Lecture 89Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study

Lecture 90Bioequivalence Study - Discussion - Dissolution Testing

Lecture 91Bioequivalence Study - Generic Approval and Additives Labeling Requirements

Lecture 92Introduction to Variation Management | Reasons for Variation | Working in Variation Department

Lecture 93Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline.

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 Letter

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

Section 5Biopharmaceutical (Biologics and Biosimilar) Regulations

Lecture 99Introduction of Biologics

Lecture 100Classification of Biopharmaceutical

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 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 Development

Lecture 119Bio-Manufacturing Process Information

Lecture 120Studies required for approval of biosimilar

Lecture 122Comparability of Biologics | Different Categories of Comparability | General Principles

Lecture 123CQA (Critical Quality Attribute) and CPP (Critical Process Parameter)

Lecture 124ATMPs | Types and Classification | Regulatory Mechanism

Lecture 125mAB - At a glance

Lecture 126ATMPs - at a glance

Section 6European Drug Regulatory Affairs

Lecture 129Introduction to EU Regulation

Lecture 130Orientation to European Countries and National Regulatory Bodies

Lecture 131EU Drug Discovery Development to Commercialization (Step By Step)

Lecture 132Overview of EU Regulation

Lecture 133EMA and EMA Authorisation Process

Lecture 134EU MA Application Types and Strategic Planning

Lecture 135EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure

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 MA - 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 Characteristics

Lecture 142Compassionate Use

Lecture 143MHRA - UK Regulation

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 & Differentiation

Lecture 147EU Prime Designation

Lecture 148Accelerated assessment by EMEA

Lecture 149EU Adaptive Pathway

Lecture 150European public assessment report (EPAR) - Importance, Component, Management, Updation

Lecture 151SPOR - Concept of Master Data Management

Lecture 152PDE Value : What is PDE value of API? Significance and How PDE value is derived?

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 File

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 device

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 Devices

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 Devices

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 188EU MDR | Annexes | Key notes

Lecture 190EU MDR Guideline | EU MDR - Annexes

Lecture 191EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart

Lecture 192EU MDR Authorized Representatives | Mandate | Role and Responsibilities

Lecture 193EU MDR Compliance Process

Lecture 194Thumb Rules of Classification as per EU MDR Guideline | Invasive | Non-invasive | Active | Special Devices

Lecture 195Review : DDF DHF DMR MDF DHR

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 dossier

Lecture 198Quality Management System (QMS) for medical devices company

Lecture 199Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management

Lecture 200Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File

Lecture 201Medical Device Essential Principle Checklist | Documentation | Open file

Lecture 202Implant Card | Regulatory Importance | Content | How to design

Section 13Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents

Lecture 203Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents

Lecture 204Instruction for Use (IFU) | Design and Development of IFU

Lecture 205UDI | Different Component | How to design

Section 14CE Marking

Lecture 207CE Certification Readiness Checklist

Lecture 208NB Mock Audit Weighted Scoring Model Aligned with Severity Grading

Lecture 209Notified Body (NB) Audit Defense Documentation Framework

Lecture 210NB Audit Defense Question Bank - Defense Response

Lecture 211Executive CE Risk Heat Map

Lecture 212CE Certification Prime Module

Lecture 213CE- Self Certification

Lecture 214CE Certification Case Studies

Lecture 215CE Self-Certification Vs NB Route Comparison [Royed Training]

Lecture 216CE Route Decision Tree

Section 15ISO 13485

Lecture 217Introduction to ISO 13485 | Importance | Comparison with various other standards

Lecture 218ISO 13485 Documentations | Different Sections | Case Studies

Lecture 219ISO 13485: 2016 - Different Clauses

Section 16Combination Product Regulatory Affairs

Lecture 221Combination Product RFD Designation Process | Importance | Timeline | Outcome Management

Lecture 222Combination 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 223Medical Devices Regulation in India | Overall understanding

Lecture 224Regulatory Landscape in India

Lecture 225Classification of the Medical Devices in India | Strategic Planning for the Submission

Lecture 226Notified and Non-notified Device | Submission Strategic Planning

Lecture 227Medical Devices Classification in India - Work Doc

Lecture 228Notified Devices | Registration Process

Lecture 229Medical Device Submission Strategic Pathways | Step by step Process

Lecture 230Medical Device Forms | Purposes

Lecture 231Non Regulatory Medical Devices

Lecture 232Medical Device Voluntary Registration | Documentation | Process

Lecture 233List of Notified Devices | Newly Notified Devices | Significance

Lecture 234List of Notified Bodies with CDSCO

Section 18Introduction to AI in QA RA

Lecture 235Introduction to AI

Lecture 236Basics of AI ML DL | Key Differences | Application in industry

Lecture 237Types of AI

Lecture 238AI Project | Overview

Lecture 239Comprehensive Training on AI Project | Managing Stages | AI Iteration

Lecture 240How machine learning

Lecture 241Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study

Lecture 242Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation

Lecture 243AI Application across drug life cycle | Case Analysis | Model predictions

Lecture 244AI Terms with Regulatory Significance | Regulatory Applications

Lecture 245NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling

Lecture 246Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise

Lecture 247Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets

Lecture 248AI Data Quality Standard | Checklist

Lecture 249Download AI Data Quality Checklist

Lecture 250Case Study: Accelerated Approval Using Real-World Evidence AI

Lecture 251AI Model for Dossier Submission and Filing - Model Selection | Simulation

Lecture 252AI Technologies in RA

Lecture 253Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets

Lecture 254Sample Data Exercise | Data error | Data Refinement and Cleaning of the data

Section 19AI in Regulatory Authoring and CMC Writing

Lecture 255AI-Powered Regulatory Document Authoring and CMC Writing

Lecture 256AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)

Lecture 257Tips for Selecting AI Tools (CMC Authoring)

Lecture 258CMC - AI Workflow Checklist | Simulation Based Cases

Lecture 259HITL Regulatory Document Authoring

Lecture 260Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring

Lecture 261Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]

Section 20eCTD v4.0 Training

Lecture 262eCTDV4.0 Fundamental Understanding | Structures | Key Features

Lecture 263eCTDV4.0 Structure | Lifecycle Management

Lecture 264eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management

Lecture 265eCTD Validation Tools

Lecture 266eCTD Publishing Cycle

Lecture 267HL7 - Structure and Understanding in the context of eCTD V4.0

Lecture 268Tips and Submission Readiness Checklist

Lecture 269eCTD Submission Checklist Format

Lecture 270Regulatory Publishing Document Control Challenges

Lecture 271Document Control Checklist

Lecture 272Leaf Structure Analysis | Common Error in Leaf Structuring

Lecture 273Formatting Rules Templated and Agency Specification

Lecture 274Versioning for Regulatory Publishing

Lecture 275File Naming Standard

Lecture 276Text Recognition and Optical Character Recognition (OCR)

Lecture 277Versioning File Naming OCR - How they work together

Lecture 278Final Document Assembly

Lecture 279Visual Diagram : eCTD Structure and XML Hierarchy

Lecture 280TOC and CI Management

Lecture 281Initial Submission & Maintenance Submission

Lecture 282Managing Lifecycle Operators - NEW REPLACE DELETE APPEND

Lecture 283eCTD Dossier Lifecycle - Multi Sequence View

Lecture 28410 Year eCTD Lifecycle : Sequence Evolution Diagram

Lecture 285Global Decision Tree - Classifying Post Approval Changes

Lecture 286eCTD Technical Validation | Typical issues | Resolutions

Lecture 287eCTD Validation Readiness Checklist

Lecture 288QC Checklist Design and Pre Submission Review

Lecture 289Submission Gateway | FDA ESG • EMA CESP • Health Canada Portal • PMDA Gateway

Lecture 290Regulatory Publishing Simulation

Lecture 291Pre-Gateway Submission Review Checklist | Post Submission Confirmation

Section 21AI and Data Integrity

Lecture 292AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases

Lecture 293Cases of data breaches with explanation

Lecture 294Case Based Discussion : Data Breach in AI-Assisted CMC Drafting

Section 22AI in Regulatory Labelling and Artwork

Lecture 295CCDS Management

Lecture 296CCDS Management Tools - Native, AI Plus | Key Functionalities

Lecture 297AI Augmented Labelling Compliance System

Lecture 298Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management

Lecture 299AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations

Lecture 300CCDS Management Case Study | Pregnancy Warning Upgrade Case Study

Lecture 301CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis

Lecture 302Centralized Artwork Operation | Mechanism | Operation Step Planning

Lecture 303Case Study on Centralized Artwork Operation [Recall Management]

Lecture 304Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases

Section 23Real World Evidence and Real World Data | Strategic Decision Making

Lecture 305Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?

Lecture 306RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making

Lecture 307RWD and RWE in Product Lifecycle Management

Lecture 308RWD and RWE - Fit to use | Assessment

Lecture 309RWD data sources | Different types | Detailed understanding of each class

Lecture 310RWD Study Design

Lecture 311RWE Published Tool | Insights on commonly used tools

Lecture 312Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models

Lecture 313Consensus Narrative Review

Lecture 314Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics

Lecture 316RWD Characteristics

Lecture 317RCT vs. RWE Comparison | Case Based Analysis

Lecture 318RCT and RWE Comparison

Section 24Working on Healthcare Datasets

Lecture 319Introduction to Healthcare Datasets

Lecture 320Dataset 1: Claims Data (Insurance)

Lecture 321Dataset 2: Retail Pharmacy Prescription Data

Lecture 322Dataset 3: Longitudinal Patient Data

Lecture 323Characteristics of Different Set of Healthcare Data

Lecture 324Reimbursement and Pricing Datasets

Lecture 325RWE Data Sources & Quality Considerations Checklist | Case Based Analysis

Lecture 326Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing

Lecture 327RWD & RWE Case Database

Lecture 328RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis

Section 25AI Tools, Ethics and Future Landscape

Lecture 329AI Reg Tools - Review | Understanding Capabilities

Lecture 330Regulatory Authority View on AI Adoption

Lecture 331Data Sensitivity | Levels | Consequences | Management

Lecture 332Governance Flowchart – AI Tools in GxP Environments

Section 26AI Tools

Lecture 333RA Example - Generalist Vs. Specialist AI Tools

Lecture 334AI Generalist Overview (Life Science Focus)

Lecture 335Horizontal vs Vertical AI Tools

Lecture 336AI Tool Assessment Test

Lecture 337Citation Verification Workflow | AI Tools Management | Hallucination and HITL Action Plan

Section 27Prompt Engineering

Lecture 338Prompt Engineering – Basic Foundations of Prompt Writing | Different Prompt Framework | Case Based Examples

Lecture 339Special Prompting Structure - Case Based Prompt Designing

Lecture 340Special Prompting Structure - Case Based Prompt Designing

Lecture 341Workflow for writing AI Prompts with Life Science Industry Use Cases

Lecture 342PE Parameters | Controlling Creativity, Accuracy, and Output Behavior for Life-Science Applications | Simulation based decision making

Lecture 343How to adjust the parameters | Techniques

Lecture 344Creating A Detailed Regulatory Prompt | Designing Structured Prompt in Code Editor

drug regulatory affairs course, regulatory quality assurance course

Quality Assurance Regulatory Affairs Course [QARA Dual Specialization)

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Introduction

Who should attend

Why QARA Program

Learning Features

Related Courses

About QARA

QARA Course Snapshots

Who should attend this

Quality Assurance Regulatory Affairs Course?

Why Quality Assurance Regulatory Affairs Course (QARA Program)?

Learning Features of Quality Assurance Regulatory Affairs Course:

Few of the similar courses to Quality Assurance Regulatory Affairs Course

Quality Assurance (QA)

Regulatory Affairs (RA)

Royed Training

Quality Assurance Regulatory Affairs Course [QARA Dual Specialization)

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Introduction

Who should attend

Why QARA Program

Learning Features

Related Courses

About QARA

QARA Course Snapshots

Who should attend this

Quality Assurance Regulatory Affairs Course?

Why Quality Assurance Regulatory Affairs Course (QARA Program)?

Learning Features of Quality Assurance Regulatory Affairs Course:

Few of the similar courses to Quality Assurance Regulatory Affairs Course

Quality Assurance (QA)

Regulatory Affairs (RA)