About Courses

The computerization of healthcare is more than simply a regulatory requirement. It not only lowers risk but also increases system understanding throughout project implementation and mandates a well-defined, structured execution of the project. Validation of pharmaceutical computer systems has the potential to save money and time for businesses by examining their computers to maximize effectiveness and enhance quality. CSV SMEs will play a key role in achieving these advantages.

Our Pharma Educare CSV Course is based on 21 CFR and will be useful to individuals involved in conducting FDA inspections and Computer System Validation (CSV) on both a domestic and international scale or who are just about to enter the CSV field. 

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  • Duration 10 Hours
  • Language English
  • Speaker TBA
  • Certification Attendance Certificate

Description

21 CFR Part 11 is the regulatory framework that this course is based on. It will provide a quick summary of CSV activities. The concepts of CSV, as well as various aspects of validation, will be discussed. This training will cover essential principles and an overview of computer systems compliance in general. The categorization of software and hardware according to GAMP 5, along with different validation techniques, are all part of this course. Developing URS, FRS, FAT, SAT, IQ, OQ, and PQ will also be reviewed

Courses Outcomes

By the end of the course, you will be able to:

  • Understand the provisions of 21 CFR Part 11
  • Categorize software and hardware according to GAMP
  • Develop a URS, FRS, FAT, SAT, IQ, OQ, and PQ
  • Understand different validation techniques
  • Apply the concepts of CSV in real-world scenario

Who Should Attend

This course is beneficial for CSV professionals, software and hardware developers, quality assurance personnel, validation engineers/managers, and project managers. It will also be useful for those who want to enter the CSV field. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers) can also take this course.

  • Duration 6 Months
  • Language English and Hindi
  • Speaker Naveen
  • Certification Advanced English Proficiency Course

Designed by PharmaEducare & Reviewed by Qualitas Globus (An Analytical Laboratory)

Description

This comprehensive course is designed specifically for B Pharmacy & M.Pharmacy graduates who aspire to excel in the pharmaceutical industry. Covering key areas of Quality Assurance (QA), Quality Control (QC), and Research & Development (R&D), this course provides a solid foundation in essential concepts, techniques, and practices.

Course Duration

The course will be conducted over 6 months, with classes held twice a week.

Certification

Upon completing the course and passing the final assessment, participants will be awarded a Certificate in Advanced Pharmaceutical Quality Assurance, Quality Control, and Research & Development. The certificate will be reward by PharmaEducare, Skill India. LSSSDC & ISO logos.

Enrollment

Enrollment for the course is now open. Interested candidates can register online through the official website or contact the admissions office for further details.
Contact no: +916300427121

Charges

The Advanced Course in Pharmaceutical Quality Assurance, Quality Control, and Research & Development is priced at 400 Rs.

 Don’t miss this opportunity to enhance your skills and unlock exciting career prospects in the pharmaceutical industry. Join us on this journey of learning and discovery!