Regulatory Affairs

Quality Solutions

Training

In Navi Mumbai

₹ 25,000 VAT incl.

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Description

  • Type

    Training

  • Level

    Intermediate

  • Location

    Navi mumbai

  • Duration

    3 Months

  • Start date

    Different dates available

Course Content:
- GMP, Quality Assurance, GLP
- Method, Process & Cleaning Validations
- Deviation management, CAPA
- CTD & e CTD, Dossier
- Audits & Inspections by Different Regulatory agencies
- Regulatory Compliance for WHO & ICH Guidelines
- Regulations for Pharma Research
- TQM – Concepts & Execution

Facilities

Location

Start date

Navi Mumbai (Mahārāshtra)
See map
Sector-3, Neel Residency-2, Wing G-001, Opp. Dwarka Sweets, New Panvel, 410206

Start date

Different dates availableEnrolment now open

About this course

Undergraduates, Graduates and Post Graduates in Science, Pharmacy, Medicine, Pharma Executives

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Reviews

Subjects

  • Quality Assurance
  • Compliance
  • Regulatory Compliance
  • Research
  • GMP
  • GLP
  • CAPA
  • CTD
  • ECTD
  • Method validation
  • Process Validation
  • Cleaning Validation
  • Audits
  • Inspections
  • Deviation management
  • WHO and ICH
  • Guidelines
  • TQM
  • Execution
  • Pharma research

Teachers and trainers (1)

Vishalakshi Naik

Vishalakshi Naik

Consultant & Trainer in GMP, GLP, GCP, and External Auditor.

Managing Proprietary Consultancy Firm “Quality Solutions”. Founder Director of Consultancy & Training company "Center for Clinical Research and Training Pvt. Ltd." & Experience in the Pharmaceutical, Food & Cosmetic Industry since 1988. Managed the activities of NGO in Administering Manufacturing & Distributing over 300 Spiritual / educational books in all over India. Managed to Co-ordinate & Set MIS (Management Information System) for Spiritual & Social Welfare NGO related activities in India & Abroad like collecting donations, distributing material for the cause of NGO.

Course programme

Eligibility: Undergraduates, Graduates and Post Graduates in Science, Pharmacy, Medicine, Pharma Executives

Prerequisites: Basic English, Basic Knowledge of Pharma Industry

Course Level: With Practical Assignments, 100% Industry Working Faculty.

Course Content:

  • GMP, Quality Assurance, GLP
  • Method, Process & Cleaning Validations
  • Deviation management, CAPA
  • CTD & e CTD, Dossier
  • Audits & Inspections by Different Regulatory agencies
  • Regulatory Compliance for WHO & ICH Guidelines
  • Regulations for Pharma Research
  • TQM – Concepts & Execution

See related categories

Regulatory Affairs

₹ 25,000 VAT incl.

The best Medicine Specialities courses

See all

See all