Good Manufacturing Practice (GMP) – Remote Online Training

Course Objectives:

By the end of this course, participants will:

1. Understand the principles and importance of GMP in the pharmaceutical, food, and biotechnology industries.
2. Learn regulatory requirements for GMP compliance as per FDA, WHO, EU, and other global standards.
3. Identify key GMP components, including documentation, hygiene, quality control, and risk management.
4. Develop the ability to recognize and prevent GMP violations.
5. Gain practical knowledge on implementing and maintaining GMP in a remote or on-site setting.

Learning Outcomes:

Upon successful completion, participants will be able to:

• Explain the core principles and regulations of GMP.
• Demonstrate knowledge of facility and equipment requirements for GMP compliance.
• Interpret and implement proper documentation and record-keeping.
• Recognize GMP non-compliance issues and recommend corrective actions.
• Develop and apply risk management techniques in GMP environments.
• Understand best practices for audits and inspections.

Target Audience:

• Quality Assurance (QA) and Quality Control (QC) professionals
• Production and Manufacturing personnel
• Regulatory and Compliance officers
• Research and Development (R&D) professionals
• Supply Chain and Logistics managers
• Anyone involved in GMP-regulated industries

Course Methodology:

This online course utilizes:
✔ Live Virtual Sessions: Interactive instructor-led training with Q&A sessions.
✔ Pre-recorded Video Lectures: Covering essential GMP topics with real-world examples.
✔ Case Studies & Scenarios: Analysis of real-life GMP violations and compliance strategies.
✔ Interactive Activities & Quizzes: Reinforcing concepts through exercises and self-assessments.
✔ Discussion Forums & Peer Engagement: Encouraging knowledge-sharing and networking.
✔ Final Assessment & Certification: Evaluation through a quiz/test and certification of completion.

Course Outline:

Module 1: Introduction to GMP

• Definition and importance of GMP
• Regulatory agencies and GMP enforcement (FDA, WHO, EMA, etc.)
• Historical evolution of GMP standards

Module 2: GMP Regulations and Guidelines

• Global GMP standards (US, EU, WHO, PIC/S, ICH)
• Differences between GMP, cGMP, and other quality standards
• Key compliance requirements

Module 3: GMP Facility & Equipment Requirements

• Facility design, layout, and environmental control
• Equipment maintenance and calibration
• Cleaning and validation procedures

Module 4: Documentation and Record Keeping

• Importance of accurate documentation in GMP
• Batch records, SOPs, and logbooks
• Electronic vs. paper records and data integrity

Module 5: Personnel and Hygiene in GMP

• Employee training and qualification requirements
• Hygiene and contamination control measures
• Roles and responsibilities of GMP personnel

Module 6: Quality Control & Risk Management in GMP

• Quality Management System (QMS) and Quality Risk Management (QRM)
• Common risks and mitigation strategies
• Handling deviations, CAPA (Corrective and Preventive Action), and change control

Module 7: GMP Audits and Inspections

• Internal vs. external audits
• Preparing for regulatory inspections
• Addressing audit findings and implementing improvements

Module 8: GMP Case Studies & Best Practices

• Analysis of real-world GMP compliance issues
• Implementing GMP in different industries (Pharmaceuticals, Food, Biotechnology)
• Ethical considerations and continuous improvement

Assessment & Certification:

• Quizzes & Knowledge Checks: After each module.
• Case Study Assignments: Real-life scenarios for practical application.
• Final Online Exam: Multiple-choice and scenario-based questions.
• Certificate of Completion: Issued upon passing the final assessment.