Drug Regulatory affairs (DRA) course for Freshers

Drug Regulatory affairs (DRA) course for Freshers

Course Link : https://www.sgpharmatrainings.com/courses/461687?utm_source%3Dother%26utm_medium%3Dtutor-course-referral%26utm_campaign%3Dcourse-overview-webapp

Course Starts from 26th February 2024.

This Course is best suitable for M Pharmacy, B Pharmacy & M.Sc. freshers who wants to pursue their career into Regulatory affairs department and also best suited for beginners (below 1 years' experience) in the pharmaceutical industry.

Course duration: 15 days

Timings: Evening 8 pm to 9 pm

Mode of teaching: Online

Medium of teaching: Through SG PHARMA TRAININGS application (It was like Zoom)

Trainer: Varsha Kakkar
-worked in both API and Formulation organizations
-17+ years' experience in Regulatory affairs
- worked in Industries like Dr. Reddy's, Cipla, Pfizer...etc.

Course Syllabus:

Basics on pharmaceutical industry
• Introduction to Pharmaceutical industry
• What is pharma industry
• Different types of industries
Branded drugs Vs Generic drugs
Overview of Departments
• Quality assurance (QA)
• Quality control (QC)
• Microbiology
• Regulatory affairs
• Research and development
• Production
• Pilot plant
• Warehouse (Stores)
• ETP
Role of Regulatory affairs
• Regulatory authorities (USFDA, EMA, TGA, etc.)
• What do you mean ANDA?
• What is DMF? (Drug master file)
• Different types of applications
• How to register a product in different countries
• What is ROW (Rest of the world) market
• Drug approval process
• What is GDUFA
• Japanese Regulation (PMDA)
• What do you mean by orange book
• Validations (Process and method validations)
Audits / complains.
• USFDA audits
• Warning letters
Guidelines
• cGMP in pharma industry
• ICH guidelines

Resume writing.
Job interview tips for fresher's

#RegulatoryAffairs
#RegulatoryAffairsTraining
#PharmaceuticalRegulations
#FDARegulations
#EMARegulations
#MedicalDeviceRegulations
#DrugApprovalProcess
#RegulatoryCompliance
#RegulatoryStrategy
#RegulatorySubmission
#QualityAssurance
#GxPCompliance
#ClinicalTrialRegulations
#RegulatoryDocumentation
#RegulatoryRequirements
#RegulatoryGuidelines
#HealthcareRegulations
#RegulatoryAffairsCertification
#PharmaceuticalLaw
#RegulatoryUpdates

Тэги:

##RegulatoryAffairs ##RegulatoryAffairsTraining ##PharmaceuticalRegulations ##FDARegulations ##EMARegulations ##MedicalDeviceRegulations ##DrugApprovalProcess ##RegulatoryCompliance ##RegulatoryStrategy ##RegulatorySubmission ##QualityAssurance ##GxPCompliance ##ClinicalTrialRegulations ##RegulatoryDocumentation ##RegulatoryRequirements ##RegulatoryGuidelines ##HealthcareRegulations ##RegulatoryAffairsCertification ##PharmaceuticalLaw ##RegulatoryUpdates

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