Menu

Quality Solutions

Pharma & IT Research Consulting & Training

header photo

MEDICAL WRITING COURSE AND TRAINING, CERTIFICATE.

Course Duration: 24 hrs. classroom, 30 to 40 hrs. assignments in 8 days / 2 months at part time weekends only.

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

Prerequisites: Basic English, Knowledge of Clinical Research

Course Content:

  • Introduction to Medical Writing,
  • Phases of Clinical trials and Study Designs,
  • Basic Statistics, Medical Writing style guide,
  • Patient Narratives, Clinical Investigator Brochure,
  • Clinical Study report, Clinical Study Protocol
  • PSUR, Clinical Trial Registry Summary,
  • ISS and ISE, CTD/eCTD, Manuscripts and Journal publication

 

Clinical Research Course, Training, Certificate.

Course Duration: 3 Months (24 hrs. classroom and 30 to 40 hrs. self-study for assignment)
(Class room/ online/ Correspondence)

Course Fees: Rs. 25000/- (Inclusive taxes, study material)

Eligibility: Undergraduates, Graduates and Post Graduates in Science, Pharmacy, Medicine, Nursing, Management, practicing and working Doctors, Pharma Executives

Course Content:

  • Module 1- Phases Of Clinical Trial
  • Module 2- Ethics In Clinical Research
  • Module 3- Clinical Operations 
  • Module 4- Clinical Data Management
  • Module 5- Pharmacovigilance
  • Module 6- Medical Writing 
  • Module 7- Regulatory Affairs
  • Module 8- Audit & Monitoring
  • Module 9- Soft Skill & Interview Preparation

Customized Selected Modules Course is also available for eligible students.

REGULATORY AFFAIRS COURSE, TRAINING, CERTIFICATE.

Course Duration: 3 Months (24 hrs. classroom and 30 to 40 hrs. self-study for assignment)                               (Class room/ online/ Correspondence)

Course Fees: Rs. 25000/- (Inclusive taxes, study material)

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

QUALITY SOLUTIONS

Neel Residency 2 CHS, G-102, Plot 34, 48-51, Sector 3, Opp. Dwarka Sweets, New Panvel, Raigad, Maharashtra 410206 India
ph: 91-9820960304
info@qualitysol.in , 
www.qualitysol.in