Certification Program - Pharma Validation

Global Institute of Regulatory Affairs
In Pune

Rs10001-20000
You can also call the Study Centre
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Important information

  • Certificate
  • Pune
  • Duration:
    3 Months
  • When:
    Flexible
Description

Validation plays a Key Role in Pharmaceutial , Clinical Trial , Medical Device , Food, Biological industries. Validation helps one establish and demonstrate that a particular activity is maintainig a desired level of compliance.

This Course is desgined for individuals who need basic, but through understanding of all the validation in pharma industry.
It will help to understand the fundamentals and concepts of Pharma Validation.
Overview and understanding of Pharma validaion, how to organize and carry out the same & the Key areas to Look forward in the whole process

Important information
Venues

Where and when

Starts Location Timetable
Flexible
Pune
Prestige Classic BLD - Dwing Off no G4 & 5, CHinchwad station Chinchwad Pune, 411019, Maharashtra, India
See map

Frequent Asked Questions

· Qualification

Graduates in any stream of science are eligible to apply.

What you'll learn on the course

Process Valiadtions
Analytical Validation
Equipment Validation
Validation Master Plan
Computer System Validation

Teachers and trainers (1)

Global Institute of Regulatory Affairs
Global Institute of Regulatory Affairs
Drug Regulatory Affairs

Course programme

    • To Study the Basic Fundamentals of Pharma Validation
    • To Understand the importance and underlying principles of pharma Validations
    • To Create a thorough/increase understanding of :
      • Validation
      • Process Valiadtions
      • Analytical Validation
      • Equipment Validation
      • Validation Master Plan
      • Cleaning Validation
      • IQ/OQ/PQ,Commissioning Activites &
      • Computer System Validation
    • Our Industry experts have developed the modules in such a way that it gives the participants in-depth knwoledge of the above mentioned points in Validation
Learning outcomeTop
    • Understand Regulatory Concepts
    • Able to write and review Regulatory Documents
    • Marketing Authorization from different countries
    • Become an RA professional
    • Preparation for audits and inspections
    • Advance to an higher level in RA career ladder

Who Should ApplyTop

  • This course is ideal for anyone in the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical and Skin/Cosmetic industries who is tasked with validation activities
  • Documentation Department
  • People involved in validation activities from product development to post-approval production concerns will find a complete insight on what regulators are looking for.
  • Research Chemist, Quality Control Chemist, CRO's, Productions,RA etc involved in Documentation
  • Will be beneficial to personnel directly involved in process/product development, manufacturing, quality control/assurance departments
  • Beginners will get to understand the in & out of Pharma Validation and Experienced Professionals can look forward to update their existing knowledge

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