Quality Assurance

 

Course Objective:

  • 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.

Course Contents:

  • Topic 1: Introduction to QA profession (Overview of the Pharmaceutical Industry)
  • Topic 2: GMP and GLP (Overview of GMP& GLP)
  • Topic 3: Introduction to ICH and Emphasis Q7 (Validation)
  • Topic 4: Quality assurance and Regulatory affairs (GMP, Documentation, Various aspects of QA)
  • Topic 5: Audit preparations (Vendor auditing)
  • Topic 6: Writing effective SOP’s in a GMP environment (Good Documentation practices)
  • Topic 7: PIC/S Guidance for API/FP

Eligibility:

  • 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

Course Duration:

  • The course duration is Three months & can be extended in special cases.

ELIGIBILITY:

A candidate seeking admission to the above programme must have passed bachelor degree in pharmacy or medical sciences. A candidate having bachelor Degree in any discipline with two years of experiences in Pharma industry will also be eligible. No age bar.

SELECTION PROCEDURE:

To Maintain High Academic Standard, Gratisol Labs Gives Due Importance To The Quality Of Students Enrolled. To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure:

  • Personal Interview
  • Screening And Selection Of Students

CERTIFICATION:

Certificate will be provided for this Course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.

A fast track weekend course will also be conducted for employees.

 For more information, please contact Gratisol Labs at This email address is being protected from spambots. You need JavaScript enabled to view it. .

 

 

 

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Contact

GRATISOL LABS – HYDERABAD
KVR Enclave, 2nd Floor, 207, Gurudwara Lane,
Beside Satyam Theater, Above ICICI Bank,
Ameerpet, Hyderabad– 500016,
Cell: +91 9705790302 / +91 8885198390
E-mail: training@gratisol.com