Steps to ensuring a successful audit – effective risk assessment design
When designing a process, product quality is an important measure of success.
To ensure product quality, it is imperative that the environment is monitored for contamination. The best way to locate sources of contamination is via risk assessment, best performed before a process has been implemented.
There are multiple tools to assist in completing a risk assessment and once completed, it is imperative to continually update this body of knowledge to guarantee a defensible monitoring program is developed and enacted
What attendees learnt during this webinar:
- Monitoring basics (includes types, locations, frequency, etc.)
- Considerations for evaluating media
- Alert and action levels
- Purpose of risk assessments
- Decision criteria and criticality factors
- Risk assessment tools
- Case study: Assessing Risks to Aseptic Processes
*Please also note that a certificate of attendance will be available upon request.
Gilberto Dalmaso, PhD, Senior Consultant and Pharma Customer Advisory Team Manager, Particle Measuring Systems
Gilberto has over 25 years’ experience in pharmaceutical microbiology and sterility assurance. Today he is a reporter to numerous symposia on microbiology and Pharma in Europe and United States.
Supported by Particle Measuring Systems
Particle Measuring Systems (PMS) sets the standard for contamination monitoring. With more than 60 patents, they create the technology that enables you to make fact-based decisions, improve process yield and comply with changing regulatory requirements. They understand the challenges their customers face and keep up with your changing needs by actively participating in industry, trade and technology groups. With more than 420 employees, they have over 35 distributors and local sales and services in more than 70 countries.
Find out more: http://www.pmeasuring.com