1). Program in Regulatory Affairs | Offline | Online | eLearning
• Basic Fundamentals of Regulatory Affairs
• Introduction to Regulatory Bodies
• Introduction to Quality Standards for Regulatory Compliance
• Common Technical Documents - CTD (API & Formulation)
• Introduction to eCTD
• ASEAN Common Technical Dossier (ACTD)
• Marketing Authorization Procedures in USA
• Marketing Authorization Procedures/ Channels in Europe
• Marketing Authorization Procedures in India
• Marketing Authorization Procedures in ROW markets
• Maintenance and Annual updates for Marketing authorizations
*Offline Program Suitable for a fresher – involves full day practical classroom training awarded with internship support on completion
*Online Program Suitable for working professionals or new comers looking for weekend learning programs
*eLearning Program Suitable for professionals with high time-constraints allowing flexibility of timing &/OR Duration
2. eCTD | eLearning
• Introduction & Overview of CTD
• CTD Fundamentals (Module 1 - 5)
• eCTD Fundamentals & Details
• Best Practice in Preparing eCTD
• Submission using eCTD Format
• Life Cycle Management for eCTD
• eCTD Software for Compilation & Validation
• Key Point for Successful eCTD Submission
• & 2 Days hands on TRAINING on eCTD Software -Lorenz Docubridge
3. Computer System Validation | eLearning
• Introduction to Validation & CSV
• GAMP 5 & Risk Based Approach
• System Development Life Cycle (SDLC)
• V- Model, GDocP, Validation Master Plan
• Data Collection and Validation Execution Activity
• 21 CFR Part 11, Part 211 & Part 820
• CSV Flowchart, Data Migration
• Data Integrity & ALCOA++
• CSV Templates & Documentation
4. Medical Device Regulatory Affairs | eLearning
• Introduction to Validation & CSV
• GAMP 5 & Risk Based Approach
• System Development Life Cycle (SDLC)
• V- Model, GDocP, Validation Master Plan
• Data Collection and Validation Execution Activity
• 21 CFR Part 11, Part 211 & Part 820
• CSV Flowchart, Data Migration
• Data Integrity & ALCOA++
• CSV Templates & Documentation
Our programs can be joined by :
- B.Pharm, M.Pharm, and Pharm.D graduates
- B.Sc, M.Sc, and Ph.D. holders in Life Sciences or Chemistry
- BE B-Tech in Biomedical engg, Pharmaceutical engg
The Global Institute of Regulatory Affairs (GIRA), based in Pune and established in 2008, is promoted by Mr. Rajkumar Gupta, the Managing Director of Perfect Pharmaceutical Consultants Pvt Ltd (PPC). GIRA offers specialized training in pharmaceutical regulatory affairs, including postgraduate diplomas and certificate.
GLOBAL INSTITUTES OF REGULATORY AFFAIRS
ISO 9001:2015 | JAS-ANZ Accredited
35 years of Expertise & Trust
Website: - https://www.regulatoryinstitute.com/index.html
Contact: - 91 9595750750 / 020 46970 4472
