Post Graduation diploma in Quality assurance and Quality management
Post Graduate Diploma
In Thane

Description
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Type
Post Graduate Diploma
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Location
Thane
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Class hours
3h
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Duration
3 Months
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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
Start date
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
Reviews
Subjects
- SOP
- GMP
Teachers and trainers (1)

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
Post Graduation diploma in Quality assurance and Quality management