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Global Institute of Professional Management Certification (GIPMC)
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Certification

Pharma Quality Assurance Expert (PQAE™)

$ 80000.00 $ 599.00

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Course Description

Quality Assurance (QA) – Pharmaceutical Sector Quality Assurance (QA) in pharmaceuticals ensures that every step of the drug manufacturing process meets global quality standards and regulatory requirements. GIPMC’s QA certification equips professionals to implement robust quality systems, GMP/cGMP compliance, and process monitoring, ensuring that medicines are safe, effective, and reliable.

Detailed Learning Outcomes

By earning the Project Management Certification (PMC), candidates demonstrate the ability to:

Module 1: Introduction to Pharmaceutical Quality Assurance

    • Overview of QA in pharmaceuticals

    • Difference between Quality Assurance (QA) and Quality Control (QC)

    • Importance of QA in safety, efficacy, and regulatory compliance

Module 2: Good Manufacturing Practices (GMP / cGMP / WHO-GMP)

    • Principles of GMP and cGMP

    • Regulatory guidelines and compliance requirements

    • Documentation and record-keeping practices

    • Common pitfalls and corrective actions

Module 3: Good Laboratory Practices (GLP)

    • Overview of GLP in pharma labs

    • Laboratory management and SOPs

    • Sample handling, storage, and testing procedures

    • Maintaining lab compliance and audits

Module 4: ISO Standards in Pharma

    • ISO 9001: Quality Management System

    • ISO 13485: Medical devices and pharma-specific standards

    • Implementing ISO standards in QA operations

    • Internal audits and continual improvement

Module 5: Risk Management & Compliance

    • Risk assessment and mitigation strategies

    • Handling deviations and CAPA (Corrective and Preventive Actions)

    • Regulatory compliance monitoring and reporting

Module 6: Analytical Testing & Documentation

    • Analytical testing procedures and validation

    • Sample analysis, calibration, and instrument management

    • Documentation standards and record-keeping

Module 7: Practical Applications & Case Studies

    • Real-world QA scenarios in pharma manufacturing

    • Case studies on quality failures and corrective actions

    • Best practices in process monitoring and product release

Module 8: Exam Preparation & Mock Tests

    • Sample MCQs and practice papers

    • Tips for exam strategy and time management

    • Review of key concepts and regulatory updates

Certification Validity & Renewal

The Project Management Certification (PMC) issued by GIPMC is valid for three (3) years from the date of certification award.

Renewal is designed to:
  • Maintain professional credibility
  • Ensure continued alignment with modern project practices
  • Protect the long-term value of the certification
Renewal Process Includes:
  • Completion of defined continuing professional development or knowledge refresh requirements
  • Successful renewal assessment or verification, as applicable
  • Submission of renewal application before certification expiry

Timely renewal allows professionals to retain active certification status without interruption.

Exam Pattern & Structure
  • Duration Course Duration Basic Level: 2 weeks Intermediate Level: 4 weeks Advanced Level: 6 weeks Details
  • Format Objective MCQs with scenario-based questions
  • Total Questions 60/90/120/150/180
  • Evaluation Skills and competency focused
  • Passing Requirement 70%
  • Exam Mode Online proctored
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