Practical HACCP for Drug and Food Safety

Description

Level: Intermediate Target Audience: Professionals working in food and pharmaceutical industries, including Quality Assurance/Control personnel, Regulatory Affairs specialists, and Manufacturing supervisors with a basic understanding of HACCP principles. HACCP plans are focused on hazards, with the overall objective of ensuring that pharmaceuticals are safe for use. This proposed review will evaluate temporal trends in identifying, assessing, and controlling safety hazards—keywords: HACCP, Quality risk management, Hazard, Safety, Risk assessment.

Training Objectives

1. Understand the application of Hazard Analysis and Critical Control Points (HACCP) in food and drug safety.
2. Identify potential hazards specific to pharmaceutical and food manufacturing.
3. Develop and implement effective HACCP plans.
4. Integrate HACCP principles into existing Good Manufacturing Practices (GMP).

Why should you attend

Participants will leave with:

• A strong understanding of practical HACCP applications.
• Skills to develop and implement HACCP plans in real-world settings.
• Confidence in integrating HACCP principles into GMP frameworks.

Training Schedule

Session 1: Introduction to HACCP and Regulatory Framework

• Overview of HACCP and its relevance in drug and food safety.
• Regulatory requirements (e.g., FDA, WHO, EU GMP standards).
• Comparison of HACCP with other quality systems (e.g., ISO 22000).
• Interactive discussion on HACCP’s role in global regulatory compliance.

Session 2: Hazard Identification and Analysis

• Types of hazards (biological, chemical, physical).
• Hazard identification in food vs. pharmaceutical processes.
• Conducting risk assessments
• Case study: Analyzing common hazards in food and drug production.
• Group activity: Identify hazards in a sample process flow diagram.

Session 3: Defining Critical Control Points (CCPs) and Critical Limits

• Determining CCPs in the production process.
• Setting measurable and achievable critical limits.
• Tools for monitoring CCPs.
• Practical exercise: Identifying CCPs in real-life case studies.
• Hands-on practice: Developing critical limits for selected hazards.

Session 4: HACCP Plan Development

• • Structuring an effective HACCP plan.
  • Documentation requirements.
  • Integration of HACCP plans into GMP processes.
  • Group exercise: Draft a HACCP plan for a simulated product.
  • Peer review: Evaluate and refine drafted HACCP plans.

Session 5: Verification, Validation, and Continuous Improvement

• Verification vs. validation: Key differences.
• Periodic review of HACCP plans.
• Role of audits and inspections in maintaining HACCP.
• Role-playing exercise: Conducting a mock HACCP audit.
• Discussion: Addressing non-conformities and corrective actions.

Session 6: Final Q&A, Knowledge Check, and Wrap-Up

• Recap of key learnings.
• Open floor for participant questions.
• Feedback and evaluation of the training session.
• Quiz: Test knowledge of HACCP principles and applications.
• Group discussion: How to apply HACCP in participants’ own facilities.

Training Materials

• Presentation slides.
• HACCP plan templates.
• Case studies and scenario worksheets.
• Assessment quiz with answer key.

Speaker

Kossi Molley, Chemist; LSSBB; PMP; Certified Trainer