Post Graduation diploma in Quality assurance and Quality management

Raaj GPRAC
In Thane

Rs 15,000
You can also call the Study Centre
98191... More
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Important information

  • Post Graduate Diploma
  • Thane
  • 3 hours of class
  • Duration:
    3 Months
  • When:
    Flexible
  • Credits:
Description

1)Introduction to QA profession
General Overview of the Pharmaceutical Industry, its functioning, role of various
departments within the industry
2)GMP and GLP
Overview of GMP
Overview of GLP
3)Introduction to ICH and Emphasis Q7
Validation - Introduction, Process, Cleaning, Water system, HVAC, Sterile
Processes and Computer Systems
4)Quality assurance and Regulatory affairs
GMP - a study of Schedule M of D & C Act, WHO requirements, USFDA
guidelines. To include premises, personnel, cleaning, sanitation, equipment,
manufacturing operations and Documentation
5)Audit preparations
Evaluation of GMP compliance to International Regulatory Standards
6)Writing effective SOPs in a GMP environment
The Role of SOP’s in Quality Documentation Systems
7)PIC/S Guidance for API/FP

Important information Venues

Where and when

Starts Location Timetable
Flexible
Thane
400609, Maharashtra, India
See map

Frequent Asked Questions

· What are the objectives of this course?

To ensure the arrangements made for the manufacture, supply and use of correct starting and packaging materials. Quality improvement plans. Validation and technology transfer. Review of stability data and shelf life of product. Incurring medicament’s that are safe and effective. Implementation of QMS. Control, update and revision of QMS documents. Conduct internal Audit and coordinate with different regulatory bodies for certification. Coordinate with client for external / third party audits Maintain and control the Manual and SOP/MS/Written Practices. Control and monitoring of NCR’s Second party audit of vendors and subcontractors. Preparation of documentation and Quality related procedures Conducts Quality Review Meeting. Review and analyze customer complaints and other re-occurring problems in the process.

· Who is it intended for?

All those who have completed their Graduation or Post Graduation/Pharma / PhD are eligible to enroll for the course. QC/QA, Mfg. Managers & Staff Regulatory Affairs Department , R & D staff, CRO

What you'll learn on the course

SOP
GMP

Teachers and trainers (1)

Rajashri Ojha
Rajashri Ojha
Teacher

Course programme

  • To ensure the arrangements made for the manufacture, supply and use of correct starting and packaging materials.
  • Quality improvement plans.
  • Validation and technology transfer.
  • Review of stability data and shelf life of product.
  • Incurring medicament’s that are safe and effective.
  • Implementation of QMS.
  • Control, update and revision of QMS documents.
  • Conduct internal Audit and coordinate with different regulatory bodies for certification.
  • Coordinate with client for external / third party audits
  • Maintain and control the Manual and SOP/MS/Written Practices.
  • Control and monitoring of NCR’s
  • Second party audit of vendors and subcontractors.
  • Preparation of documentation and Quality related procedures
  • Conducts Quality Review Meeting.
  • Review and analyze customer complaints and other re-occurring problems in the process.

Additional information

For further enquiries or Prospectus, write to or call us on: localhost, info@rajgprac.com , raajgprac@gmail.com, rajashrio@gmail.comwww.raajpharmaelearning.com@mtnl.net.in Phone no: 9819488208 / 9821144706 / 022 65619030 /022 25445541

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