InstructorRoyed Training
TypeOnline Course
Price$930 USD / 46500 INR.
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Quality assurance documentation

Introduction

Features

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About QAD

quality assurance documentation training course

Welcome to our comprehensive e-learning course on Pharmaceutical and Medical Device Quality Assurance Documentation. In the dynamic and highly regulated landscape of healthcare products, ensuring quality and compliance is paramount. This course is meticulously designed to equip professionals with the knowledge and skills necessary to navigate the intricacies of quality assurance documentation in the pharmaceutical and medical device industries.

In these online self-paced modules, participants understand the quality assurance documentation for development to commercialization of pharmaceutical and medical devices. In other words, you will understand various quality assurance requirements for successful launch and management of the products in the market. Hence, the course covers fundamentals to advance learning on drugs, biologics and medical devices development, regulation, registration and strategic management processes.

Course provides 1000s of prebuilt SOPs in open format which give users to understand overall quality documentation for plant management.

This comprehensive course in quality assurance documentation provides a deep understanding of quality assurance documentation principles, regulatory requirements, and industry best practices specific to pharmaceutical and medical device sectors. Moreover, this course provides hands on practical training in writing, managing, and controlling documentation essential for maintaining compliance and ensuring product quality. Participants will gain the knowledge and skills necessary to navigate the complex and ever changing quality management system landscape. Therefore, this course will make participants valuable assets to pharmaceutical and medical device companies, regulatory agencies, and related organizations.

Who should attend this 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.

Course Snapshots

  • Course Code: RYD-116
  • 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.

Core Area of the Quality Assurance Documentation Training

  • Understanding Regulatory Requirements: Gain a comprehensive understanding of the regulatory requirements and guidelines governing quality assurance documentation in the pharmaceutical and medical device sectors.
  • Ensuring Compliance: Learn how to ensure compliance with regulatory standards and industry best practices related to documentation management, thereby minimizing the risk of non-compliance and associated penalties.
  • Developing Document Control Skills: Develop practical skills in establishing, maintaining, and controlling documentation through effective document control systems, version control, issuance procedures, and archival processes.
  • Mastering SOP Development: Master the art of writing clear, concise, and compliant Standard Operating Procedures (SOPs) essential for outlining critical processes and procedures within pharmaceutical and medical device manufacturing and quality assurance.
  • Implementing Good Documentation Practices (GDP): Understand and implement principles of Good Documentation Practices (GDP) to ensure the integrity, accuracy, and reliability of documentation, thereby upholding product quality and regulatory compliance.
  • Enhancing Quality Management Systems (QMS): Acquire the skills to implement and maintain robust Quality Management Systems (QMS) that drive continuous improvement, facilitate efficient documentation management, and support regulatory compliance.
  • Preparing for Audits and Inspections: Learn strategies for preparing and navigating regulatory audits and inspections effectively, including documentation requirements, best practices, and audit readiness techniques.
  • Implementing CAPA Processes: Understand the importance of Corrective and Preventive Actions (CAPA) in quality management, and learn how to implement effective CAPA systems, including documentation of processes, root cause analysis, and effectiveness evaluation.
  • Real-World Application: Apply learned concepts through real-world case studies and practical exercises designed to reinforce understanding, enhance problem-solving skills, and prepare participants for the challenges they may encounter in their professional roles.

Features of Pharma and Medical Device

  • Comprehensive understanding of quality assurance documentation principles and practices.
  • Compliance with regulatory requirements, reducing the risk of non-compliance and associated penalties.
  • Enhanced efficiency and effectiveness in document management processes.
  • Improved product quality, safety, and patient outcomes.
  • Practical skills to apply learned concepts in real-world scenarios.

Case Based Learning

  • Course provides 1000s of prebuilt SOPs in open format which give user to understand overall quality documentation for plant management.
  • Access to Case Studies to learn about the quality assurance documentation decision making in case to case scenarios. Hence, participants will develop practical job related competency.

Career in QA and Documentation

A career in Quality Assurance (QA) and Documentation within the pharmaceutical and medical device industries offers a diverse range of opportunities for individuals passionate about ensuring the safety, efficacy, and compliance of healthcare products. Here are some key aspects and potential career paths within this field:

Quality Assurance Specialist: QA specialists play a critical role in ensuring that pharmaceutical and medical device manufacturing processes adhere to regulatory standards and company procedures. They are responsible for implementing quality systems, conducting audits, reviewing documentation, and ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations.

Document Control Specialist: Document control specialists manage the lifecycle of documentation within an organization, ensuring that documents are created, reviewed, approved, distributed, and archived according to established procedures and regulatory requirements. They play a key role in maintaining document integrity, version control, and accessibility.

Regulatory Affairs Specialist: Regulatory affairs specialists are responsible for ensuring that pharmaceutical and medical device products comply with regulatory requirements set forth by government agencies such as the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency). They are involved in preparing regulatory submissions, responding to regulatory inquiries, and staying informed about changes in regulations that may impact product development and marketing.

Quality Control Analyst: Quality control analysts are involved in the testing and inspection of pharmaceutical and medical device products to ensure that they meet quality standards and specifications. They perform analytical testing, microbiological testing, and physical inspections to assess product quality and identify any deviations or non-conformities.

Validation Specialist: Validation specialists are responsible for validating equipment, processes, and systems used in pharmaceutical and medical device manufacturing to ensure they meet regulatory requirements and produce consistent and reliable results. They develop validation protocols, execute validation studies, and analyze validation data to ensure compliance and product quality.

Compliance Officer: Compliance officers oversee compliance with regulatory requirements, company policies, and industry standards within pharmaceutical and medical device organizations. They develop compliance strategies, conduct internal audits, and provide guidance to ensure that operations are conducted in accordance with applicable regulations and standards.

Quality Systems Manager: Quality systems managers oversee the implementation and maintenance of quality management systems within organizations, including document control systems, corrective and preventive action (CAPA) systems, change control processes, and training programs. They ensure that quality systems are effective, efficient, and compliant with regulatory requirements.

Training Coordinator: Training coordinators are responsible for developing and delivering training programs related to quality assurance, documentation, and regulatory compliance. They ensure that employees are adequately trained on relevant procedures, regulations, and quality systems to perform their roles effectively and maintain compliance.

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 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 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 33Emergency Use Authorization (EUA) | EUA Pathways | Criteria | Justification | Early Discussion with FDA | LOA | Factsheets 
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
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 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 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 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.
Lecture 94Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System 
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 112Biological Licensing Application (BLA)  | 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 Development 
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 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
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 LBPs 
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 187EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 188EU MDR  | 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 - 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 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 Studies 
Lecture 217ISO 13485: 2016 - Different Clauses
Section 16Combination Product Regulatory Affairs
Lecture 218Combination Products Regulatory Affairs | Definition |  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 Submission 
Lecture 224Notified and Non-notified Device | Submission Strategic Planning 
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