Courses

Biologics/Biosimilar Submission as per US and EU

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 Science

• 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

Medical Device labeling as per EU and ISO 15223

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

• Symbols Used for Medical Device Label

• ISO 15223: 2021 - New Version Changes

Pharmaceutical Product labeling as US, EU and India

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 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

Computer System Validation, 21 CFR part 11, GAMP 5

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

• What is Computer System Validation (CSV)

• V-Model of Computer System Validation

• Life Cycle Phases of a Computer System

• 21 CFR Part 11

• GAMP5

• Data Integrity and ALCOA+

• Common Computer System Validation Problems

• Benefits of Computer System Validation

Computer System Validation, 21 CFR part 11, GAMP 5

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

• What is Computer System Validation (CSV)

• V-Model of Computer System Validation

• Life Cycle Phases of a Computer System

• 21 CFR Part 11

• GAMP5

• Data Integrity and ALCOA+

• Common Computer System Validation Problems

• Benefits of Computer System Validation

Good Manufacturing Practice

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.

Medical Device-Health Canada

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.