HACCP & Preventive Controls: Design, Implementation & Compliance

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Learn how to design and implement HACCP and preventive control systems to identify risks, strengthen quality assurance, and ensure compliance in pharmaceutical manufacturing.

By HUKSA

Last updated March 11, 2026

This program provides a structured understanding of Hazard Analysis and Critical Control Points (HACCP) and preventive control systems within pharmaceutical manufacturing and related healthcare product environments. Participants will learn how to identify potential hazards, establish critical control points, and design preventive control strategies to ensure product safety, quality, and regulatory compliance. The course equips professionals with practical tools to integrate HACCP principles into pharmaceutical quality management systems and risk-based manufacturing practices.

Course Content

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Overview of HACCP methodology and its evolution

Role of risk-based quality management in pharmaceutical manufacturing

Regulatory expectations for preventive controls and contamination management

Relationship between HACCP, GMP, and pharmaceutical quality systems

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Types of hazards: biological, chemical, physical, and cross-contamination risks

Hazard analysis techniques in pharmaceutical production

Risk evaluation and prioritization methods

Identifying potential hazards across manufacturing processes

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Criteria for determining critical control points

Setting critical limits and process parameters

Monitoring procedures for CCPs

Documentation and control mechanisms

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Designing preventive control strategies for contamination prevention

Process control systems and quality monitoring tools

Managing deviations and corrective actions

Integration with quality assurance and production operations

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Verification of HACCP systems and process controls

Validation of critical processes and preventive measures

Documentation requirements and recordkeeping practices

Preparing for regulatory inspections and quality audits

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Case study: contamination incident due to inadequate process controls

Case study: effective HACCP implementation improving product safety

Practical exercise: mapping hazards and identifying CCPs in a manufacturing process

Developing a HACCP implementation plan for a pharmaceutical facility

Meet Your Instructor

Deep-domain, High Precision L&D - delivered directly by Renowned Industry Practitioners HUKSA

159 Course

13 Student

Offered by Huksa, this L&D program is led by elite industry veterans—CXOs and Functional Heads with 25+ years of deep-domain expertise. You have the flexibility to customize the curriculum, select your preferred expert, and align the program to your organization’s specific objectives. Connect with the Huksa team to explore our array of top-tier trainers available for this course!

₹80,000.00

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