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Certificate in Quality Management Systems

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Certificate in Quality Management Systems

  • Course Code -PCQMS03
  • Fees: 999 EUR
  • 599 EUR
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Overview

A Quality Management System (QMS) is the backbone of every pharmaceutical, biopharmaceutical, and medical device company operating in a GxP-regulated environment. Effective implementation of a QMS ensures product quality, data integrity, regulatory compliance, patient safety, and continuous improvement.

The Advanced QMS Certification Program by Pegasus Pharmaceuticals International Limited provides a complete and practical understanding of QMS principles, regulatory frameworks, documentation practices, and operational quality controls followed in the life sciences industry.

This course blends global standards, real-world case studies, and practical templates to help professionals develop the skills required to maintain a compliant quality system.

Participants will learn how to manage change control, deviations, CAPA, OOS/OOT, market complaints, product recalls, document lifecycle, and other core QMS elements that are essential for day-to-day operations in a regulated environment.

Whether you are starting your career or aiming to strengthen your expertise, this course equips you with the competence to work confidently in a quality role.

KEY COVERAGE AREAS

Detailed requirements of 21 CFR Part 11, EU Annex 11, and GAMP 5 principles for system features, infrastructure qualification, and validation

Latest industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation

Practical knowledge applicable to various GxP areas, including healthcare, clinical trials, biopharmaceuticals, and medical devices

Specific compliance considerations for on-premise, local hosting, and SaaS/Cloud-based systems

MODULES COVERED DURING THE CERTIFICATION PROGRAM

Module 1: Introduction to Quality Management Systems

• Understand the purpose, principles, and components of a QMS
• Regulatory expectations (ICH Q10, WHO, ISO, EU, FDA)
• QMS framework and its role in GxP environments

Module 2: Change Control Management

• Importance of controlled change in pharmaceutical processes
• Change request initiation, impact assessment, approvals
• Change closure and verification

Module 3: Handling Deviations

• Identification, documentation, and classification of deviations
• Root cause analysis techniques
• Deviation investigation strategy

Module 4: Investigation Tools & Techniques

• Fishbone (Ishikawa), 5 Whys, Fault Tree Analysis
• Structured problem-solving approaches
• Effective documentation of investigation results

Module 5: CAPA (Corrective & Preventive Action) Management

• CAPA lifecycle: initiation to effectiveness check
• Designing robust corrective and preventive measures
• Linking CAPA to quality improvement

Module 6: Handling Market Complaints

• Complaint intake, recording, and assessment
• Product quality complaint investigations
• Regulatory reporting requirements

Module 7: Handling Returned Goods

• Return evaluation
• Quarantine, investigation, disposition
• GMP compliance for returned products

Module 8: Handling Product Recalls

• Recall classification (FDA & EU)
• Recall initiation, execution and communication
• Post-recall effectiveness checks

Module 9: Handling OOS (Out-of-Specification) Results

• OOS investigation phases
• Laboratory hypothesis testing
• Reporting and decision-making

Module 10: Handling OOT (Out-of-Trend) Results

• Definition and detection of trends
• Statistical tools used for trend analysis
• OOT investigation and control strategies

Module 11: Handling Equipment Breakdowns

• Breakdown logging and classification
• Impact assessment on quality and data integrity
• Preventive and predictive maintenance concepts

Module 12: Document Lifecycle Management

• Document creation, review, approval, distribution
• Controlled documents vs uncontrolled documents
• Archival, retrieval, and retention policies
• Good Documentation Practices (GDP)

WHO SHOULD
ATTEND?

    • Quality Assurance (QA) Professionals
    • Quality Control (QC) Personnel
    • Regulatory Affairs Specialists
    • Validation & Qualification Engineers
    • Pharmaceutical Manufacturing Staff
    • Students & Freshers in Pharma, Biotech, and Life Sciences

Why Choose Pegasus Pharmaceuticals?

Pegasus Pharmaceuticals ensures each participant gains actionable skills that can be directly applied in real-world scenarios, improving job performance and career growth.

  •  Industry-relevant curriculum designed with global standards (FDA, EU, WHO, ISO)
  • Practical insights from seasoned industry experts
  •  Flexible weekend batches suitable for working professionals
  •  Certification upon completion
  • Trusted partner for GxP training, quality, and compliance

Course Code -PCCQV01​

Course Code: PCFV02

Duration:  6 weeks (Sat & Sun) Daily 2 hrs 
Total Classes: 4 Classes

Fees: 599 EUR 

Bring us the problem — we’ll design the team and deliver the answer.

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  • Support: +353873976644
  • info@pegasuspharmaintl.com

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