Post Graduation diploma in Quality assurance and Quality management

Post Graduate Diploma

In Thane

₹ 15,000 VAT incl.

Description

  • Type

    Post Graduate Diploma

  • Location

    Thane

  • Class hours

    3h

  • Duration

    3 Months

  • Start date

    Different dates available

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

Documents

  • 3m Advanced PG Diploma in Quality Assurance & Quality Management.pdf

Facilities

Location

Start date

Thane (Maharashtra)
See map
400609

Start date

Different dates availableNow taking bookings

About 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.

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

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Subjects

  • 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

Post Graduation diploma in Quality assurance and Quality management

₹ 15,000 VAT incl.