Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Cosmetic Regulatory Affairs, Quality Assurance

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/Cosmetics/BPO/KPO/CRO etc.

Course Description

• This course will cover What is cosmetic and cosmetic science?, Global Cosmetic Market, Cosmetic Technology, Ingredient used in Cosmetics, Nanotechnology in Cosmetic Industry, Product Development and Cosmetic Formulation, GMP for Cosmetic, ISO 22716 –GMP for Cosmetic, Raw material quality control, Packaging and labeling quality control, Finished product quality control, Regulation of Cosmetics in US, EU, India, Induction of Social and Environmental Practices in Supply Chains, Supplier Risk and Performance Evaluation, Supply Chain Management for Sustainable Products, Safety Monitoring of Cosmetic products, Cosmetic Product Safety Report, Global status of Cosmetovigilance system

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

• Introduction in Biologics
• History of Biologics
• Advancing Biomedical Sciencev
• Comparison of development and characteristics between generics and biosimilars
• Biological License Application
• General Requirement of 351(k) pathway
• Biologics Price Competition and Innovation Act
• EU legal and Regulatory pathway
• Data Requirement for Biosimilar Product in US and EU
• Submission and Approval Process for Biosimilar

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry.Regulatory affairs, R&D staff in Medical Devices.

Course Description

• Introduction to medical device label
• Area to be considered for medical device labeling
• Do’s and don’ts of labeling
• EU Medical Device labeling
• New Medical Device Requirement as per EU MDR
• Changes in Medical Device labeling
• Challenges faced by manufacturer
• Symbol used for Medical Device Label
• ISO 15223: 2021- New Version Changes

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

• Introduction to pharmaceutical labeling
• Recent Changes in FDA Medicine Labeling Requirements
• Barcodes in Pharmaceutical Labeling
• Effect of COVID-19 on Pharmaceutical labeling
• Labeling Requirements in EU
• Key considerations
• Labeling requirement in India

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

• What is Computer System Validation (CSV)
• V- model of computer system of validation
• Life cycle phases of a computer system
• 21 CFR Part 11
• GAMP5
• Data Integrity and ALCOA+
• Common computer system validation Problems
• Benefit of Computer System Validation

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

The course will cover role and responsibilities of RA, Drug development, formulation development, GMP/GLP/GCP, DMF/ASMF/CEP, Drug Regulations in USFDA, Europe, ROW countries, Canada, Regulation of OTC drugs, Drug Substance regulation (DMF/ASMF/CEP), Medical Device Regulations, Biosimilar Regulations, Post Approval Changes and Life cycle management of a Drug Product, Structure and organization of CTD(Module1-Module 5), Dossier preparation(eCTD, ACTD, Nees Format), eCTD Submission, CMC Writing and Review Skills  ICH Quality Guidance  (ICH Q1 ti ICH Q14) and its importance, 21 CFR part 11, Data Integrity, ALCOA, ALCOA+.

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

The course covers role and responsibility of RA, Importance of GMP/GLP/GCP, Drug Development process, Formulation Development, DMF/ASMF, Drug Regulation in US, Europe, ROW countries, Organization and structure of CTD-(Module 1 - Module 5), Dossier preparation as per CTD-eCTD format, CMC Writing and Review Skills , ICH Quality Guidance and its Importance (ICH Q1-ICH Q14), 21 CFR part 11.-Data Integrity-ALCOA, ALCOA+

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

This course will cover Introduction to RA profession, Characterization and Polymerization of API, Drug Substance Regulation(DMF/ASMF/CEP), Regulation in semi regulated countries, DMF submission in CTD/ ACTD format, 21 CFR part 11 and its importance.

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

This course will cover Introduction to QA profession, GMP/GLP, Introduction to ICH guidances and Emphasis on ICH Q 7, Quality Assurance and Regulatory Affairs, Documentation requirements as per GMP compliance, Audit Preparations, Writing SOPs, PICs guidance.

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

The course will cover Introduction to RA, ICh and CTD, Organization of CTD, Introduction to eCTD, eCTD Granularity, Preparing eCTD Submission, eCTD Specification for USFDA/EU, CMC Writing and Review Skills Electronic Subission Process, 21 CFR part 11.- Data Intrgrity

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

This course will cover Introduction to Clinical Profession, Overview of Drug Development Process including clinical trials, Regulatory process in preclinical drug development, Ethical Principles and their origin, Ethics in clinical research: As per ICMR & GCP, ICH E6. Fundamentals of Monitoring Clinical Trials, Principles of Project Management, Clinical Safety & Pharmacovigilance

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

This course covers importance of good documentation and how to apply, Pharmaceutical Documentation profession, WHO GMP for pharmaceuticals, Documentation of Quality Management System, Documentation and Records, Training & Qualification of Personnel, Good documentation practice for electronic documentation, Validation Documentation, Documentation control, Product development documentation-PDR writing as per ICH Q8, Stability testing and documentation, Quality by Design

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

This course will cover Introduction and Objectives of Pharmacovigilance, Drug surveillance-WHO, Classification of ADR, The importance of reporting ADR, The effects of ADRs, Pre marketing studies, Post-marketing surveillance (PMS), Pharmacovigilance Methods, Drug Event Monitoring, Uppsala Monitoring Centre, The National Pharmacovigilance Centers, Pharmacovigilance in Drug Regulation, Clinical trial regulation, Post-marketing safety monitoring, Signal Detection & Analysis, Good Pharmacovigilance Practices, Periodic Safety Update Reports: General principles, Submission of PSURs

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

his course will cover Overview of Pharma Industry and Importance of IPR & Patents, General Overview of the Pharmaceutical Industry, its functioning, role of various Departments, Definitions and interpretation of terms related to Patents System, Enforcement of Patents, Abuse of Patents, International Treaties/Conventions on IPR, Patenting in India - Legislations and Salient Features, Procedures for Patent Applications, US & European Patent Regimes, Business Model Patents - Biotech Patents, Software Patents

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

This course will cover Introducing Management Science, National and International Environment for Pharmaceutical Industry, Business Ethics and Corporate Governance, Business Communication, Organizational Behaviour, Human Resource Management, Project Management, Self Management, Pharma Quality Management, Legal and Regulatory aspects of Business, Operations Management, Management Accounting - Basics, Budgeting, Cost cutting, Quality Management & Manufacturing Strategy, Marketing and Sales Management, Importance of Regulatory Intelligence (RI) and different tools

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc.

Course Description

This course will cover Medical Writing Profession, role and its importance, Statistical Principles for Medical Writing, How to become a Competent Medical Writer?, Difference between a Technical and Scientific writing, Different Types of Medical Writing, Medical Writing Style Guide, Writing of Informed consent form (ICF) / Clinical Investigator Brochure(IB) / Clinical Study Report (CSR) and Protocol/ PSUR/DSUR/PBRER / Clinical Trial Registry Summary (CTR) and FDAAA /Preparation of Product LABEL, ICH CTD Modules.

Eligibility:

All those who have completed their Graduation or Post Graduation/ Pharma / PhD are eligible to enroll for the course.[B.Sc/M.Sc/B.Pharm/M.Pharm/ B.Tech/M.Tech/PhD or any Life science graduates]

This course would be beneficial to people who have experience in RA/QA/QC and want to proactively take part in food licensing and registration. Professionals from food companies working in various departments are also eligible.

Course Description

This course will cover Scope and Opportunity of Indian Nutraceutical Markets, Scope and regulation of Nutraceuticals across Globe, Biotechnology and Nutraceuticals, QA and QC in Nutraceutical Industry, : Food Quality Monitoring, Intellectual property Right for Nutraceuticals, Development and marketing of Nutraceutical products, GMP practices followed Worldwide in Nutraceutical Industries.

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

This course will cover GMP Guidance and its importance in Pharma industry, ICH Q 6 guidance, How to implement GMP.

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

This course will cover Basics of CMCs, effective technical CMC Writing skills, CTD Module 3-Quality Overall Summary, Purpose and Content of Module 3, Difference between technical and scientific writing skills, How to organize CTD modules, Regulatory challenges of CMC requirements

Eligibility:

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.

Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

This module will cover what is stability, its importance, how to carry out stability testing, Guidance for stability testing as per ICH Q 1.

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry.Regulatory affairs, R&D staff in Medical Devices.

Course Description

This course will cover Definition and Classification, Overview of global medical device industry, Medical device design process, MEDICAL DEVICE REGULATION IN USA, EU, Canada, India, Australia, Japan, China, Middle East, Technical file documentation, Quality management system-ISO13485:2016, risk management system-ISO 14971:2019, clinical and safety testing, MDSAP

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field.B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module will cover Difference and similarities between MDD and MDR, MDR Transition period, key aspect of new regulations, new regulatory process

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This course will cover Introduction to ISO 13485, Skills required by an auditor, how to audit using the process approach, Identify and document nonconformities, ISO 13485 Medical Devices Quality Management Systems, Provide critical knowledge for your management staff, Gain insight into the ISO 13485 audit requirements to augment/sustain your existing program.

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module will cover Risk Management (ISO 14971) in the development and use of medical devices. Standards, regulations methods, and tools for identifying, analyzing, and controlling risks, Risks and hazards associated with the system and its use so that we can reduce the probability of its harm to people and environment by using Risk analysis., Risk analysis using the harmonized standards according to your medical device.

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module will cover Establishment of regulation and device listing, Premarket notification-510(k), Premarket approval, Investigational device exemption, Labeling requirement, Medical device reporting.

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module covers New regulations, Timeline line and transition of new regulations, Key aspects of new regulations, Classifications, Registration, Notified body designation, CE Marks

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module will cover New Indian Medical Device Regulation-MDR 2017, BIS Submission, Sugam Portal Submission.

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Device

Course Description

This module will cover document requirement for medical device, Design History file (DHF),Device Master record (DMR), Device History record (DHR), Summary Technical Document (STED), Clinical Evaluation Report (CER), Unique Device Identifier (UDI),General safety and performance requirements (GSPR)

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry. Regulatory affairs, R&D staff in Medical Devices.

Course Description

This module will cover health canada- medical device regulation, type of license, application review and approval process,

Eligibility:

Diploma in biomedical / medical electronics/ electrical/any other related field. B.E/ B. Tech in Biomedical Engineering, Biomedical Instrumentation Engineering/ Medical Electronics/ any other related field. All those who have completed their Graduation or post graduation in life science/ Pharma/ PhD are eligible to enroll for the courage. QA/QC, Production, Managers and Staff working in Medical Device industry.Regulatory affairs, R&D staff in Medical Devic

Course Description

This module will cover Fundamentals of MDSAP, Origin and Objective, Key terms and Definitions, How does MDSAP works?, What are the MDSAP requirements?, Supporting documents for MDSAP, MDSAP Audit Cycle