Quality & Regulatory Affairs Courses

Rapid technological advances and increased globalization have spurred new quality, manufacturing effectiveness, and regulations compliance standards. We offer online quality and regulatory courses designed for various industries, such as pharmaceutical and medical device manufacturing.

Hazard Analysis Critical Control Points (HACCP) Online Course & Certificate

Module 1: Introduction to HACCP

Module 2: Hazard Analysis

Hazards (biological, chemical, and physical) are conditions which may pose an unacceptable health risk to the consumer. A flow diagram of the complete process is important in conducting the hazard analysis. The significant hazards associated with each specific step of the manufacturing process are listed. Preventive measures (temperature, pH, moisture level, etc.) to control the hazards are also listed.

Module 3: Identify Critical Control Points

Critical Control Points (CCP) are steps at which control can be applied and a food safety hazard can be prevented, eliminated or reduced to acceptable levels. Examples would be cooking, acidification or drying steps in a food process.

Module 4: Establish Critical Limits

All CCP’s must have preventive measures which are measurable! Critical limits are the operational boundaries of the CCPs which control the food safety hazard(s). The criteria for the critical limits are determined ahead of time in consultation with competent authorities. If the critical limit criteria are not met, the process is “out of control”, thus the food safety hazard(s) are not being prevented, eliminated, or reduced to acceptable levels.

Module 5: Monitor the CCP’s

Monitoring is a planned sequence of measurements or observations to ensure the product or process is in control (critical limits are being met). It allows processors to assess trends before a loss of control occurs. Adjustments can be made while continuing the process. The monitoring interval must be adequate to ensure reliable control of the process.

Module 6: Establish Corrective Action

HACCP is intended to prevent product or process deviations. However, should loss of control occur, there must be definite steps in place for disposition of the product and for correction of the process. These must be pre-planned and written. If, for instance, a cooking step must result in a product center temperature between 165oF and 175oF, and the temperature is 163oF, the corrective action could require a second pass through the cooking step with an increase in the temperature of the cooker..

Module 7: Record keeping

The HACCP system requires the preparation and maintenance of a written HACCP plan together with other documentation. This must include all records generated during the monitoring of each CCP and notations of corrective actions taken. Usually, the simplest record keeping system possible to ensure effectiveness is the most desirable.

Module 8: Verification

Verification has several steps. The scientific or technical validity of the hazard analysis and the adequacy of the CCP’s should be documented. Verification of the effectiveness of the HACCP plan is also necessary. The system should be subject to periodic revalidation using independent audits or other verification procedures.

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