Environmental Monitoring in Pharmaceuticals & Biotechnology

Gain essential skills to identify contaminants, apply sampling methods, manage sample transportation, incubate samples, and interpret test results effectively in a microbiological laboratory.

A robust environmental monitoring strategy is key to maintaining high standards of safety, quality, and compliance in pharmaceutical manufacturing.

Detecting and controlling microbial contamination in manufacturing environments, ensures that drugs are safe for consumption and provides critical data to assess the effectiveness of cleaning and sanitization programs for consistent product quality.

Identifying contamination trends allows for timely corrective actions, to minimise risks to both the product and the manufacturing process, while adhering to the stringent compliance guidelines set in GMP Annex 1 and FDA regulations.

Course description

This comprehensive training program equips participants with the skills to identify various microbiological contaminants and understand their significance in environmental monitoring and microbiological quality control. Attendees will learn diverse sampling methods and their practical applications, along with the challenges and key considerations in sample preservation.

The course also covers the rationale behind different incubation ranges and how to justify incubation choices. Finally, participants will gain proficiency in interpreting microbiological control results and addressing common reading difficulties.

Learning objectives

By attending this workshop, participants will:

• Apply microbiological sampling methods
• Know the particularities of transporting samples in the microbiological laboratory
• Incubating samples
• Ability to read and interpret test results

Who should attend

This activity is highly recommended for:

• Production Managers
• Production Line Team Leaders
• Operational Quality Assurance Managers
• Sterility Assurance Managers
• Maintenance Representatives
• Production Operators

Prerequisites

There are no prerequisites to attend

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