Is your cleaning validation program in compliance with establishing limits for cleaning validation? Our experts, Paul Lopolito and Beth Kroeger are hosting a comprehensive webinar in partnership with Executive Conference Corporation Webinars (ECC) on June 18th. Paul and Beth will also discuss the current European changes that established the “Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared equipment” and how these changes are linked to each other.
Our experts will discuss and examine the approaches to establishing limits for cleaning validation for the following;
- Product grouping: We will review a matrix approach to product grouping and investigate the most relevant product characteristics in order to develop a robust approach to product grouping.
- Sampling methods: The two most often used sampling methods, swab sampling and rinse sampling, will be compared along with the appropriate use for each sampling method.
- Detection method: Available detection methods will be examined and insight offered of each methods’ respective advantages and disadvantages versus one another.
- Calculating limits: By detailing the factor used in the limit calculation, Jim and Beth will share robust approaches to calculating residue limits for a variety of dosage forms and products.
Attendees will learn:
- How to determine limits by going over real examples
- Selecting worse-case residue limits
- Incorporation of Health-based limits into an existing Cleaning Validation program
- How to deal with limits lower than assay detection
- Answers to common question and issues
- Things to avoid when setting limits