Sterility Assurance Coaching Services

Boost your Sterility Assurance team’s expertise & ensure quality sterile manufacturing with PQE Group’s tailored coaching.

Tailored Training Sessions: Ensure your sterility assurance team is up to speed with regulatory standards, quality aspects, and international guidelines.
Support for Design, Issue, and Revision of Key Sterility Assurance Documentation: Improve quality standards and enhance manufacturing control with data management.
Holistic roundtables: Learn from experts how to improve your team’s planning & design strategies for process control and contamination risk.
Focused Expertise and Support: Address backlogs, prioritize training and project management, and enhance your team's capacity for documentation review and implementation.

Clients that trust us

Years of experience

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Projects executed

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Offices worldwide

Transform Your Team Into a Sterility Assurance Powerhouse

We know how Sterility Assurance can be overwhelming in our fast-paced and dynamic industry that is why our experts designed coaching solutions tailored to your business.

Holistic Sterility Assurance Coaching Services

PQE Group’s flexible Sterility Assurance coaching provides top-notch training and support on-site and online from senior and junior experts.

Tailored training sessions

Environmental Monitoring

Filtration and Sterilization strategies

Aseptic process simulations

Barrier technologies

Aseptic behaviour & interventions management

Requirements and recommendations from international standards & guidelines

Inspections Management: how to get ready to receive inspectors and discuss with them your strategies

Support for design, issue and revision of key Sterility assurance documentation, comprising:

- Contamination Control strategy

- Environmental Monitoring plan definition

- Cleaning & Disinfection validation strategy

- Aseptic process simulation strategy definition

- Environmental Monitoring data review

- Aseptic Intervention risk assessment

Round tables

To define the strategic planning of activities.

Open discussions

To share knowledge and expertise.

Other Sterility Assurance services

Compliance Assessments vs. international guidelines & standards

Preparation of a sterility assurance related QMS

Preparation & issue of site Contamination Control Strategy documents

Design of Aseptic Process Simulation strategies

Design of Environmental Monitoring plans

Personnel qualification plans

Investigations on contamination events

Evaluation of products exposure to contamination risks

Definition of data trending strategies

Count on Us for Sterility Assurance

Our Sterility Assurance Coaching team is composed of a selected group of consultants at different levels of seniority, with specific expertise.

Sterile manufacturing processes (Pharmaceutical, Biotech, APIs, Primary packaging materials, Medical devices, and more)
Contamination Control Strategies
Environmental monitoring
Utilities monitoring
Aseptic operations & personnel qualification
Aseptic process simulation
Sterilization & filtration strategies

Alessio Rosati

Sterility Assurance Head

Transform Your Sterility Assurance Today

Your team is just one step away from Sterility Assurance Expertise. Ready to transform your approach? Get in touch with an expert.