IVT Cleaning Validation Aug. 2018
August 21, 2018 @ 8:00 am - August 23, 2018 @ 5:00 pm
Back by popular demand! Join us at IVT’s Cleaning Validation Event in Philadelphia in August! We will be presenting on Day 2: User Requirements and Implementation of a Risk Based, Compliant Cleaning Validation Management System Based on the Draft Guidance on Data Integrity
In pharmaceutical manufacturing, risk of contamination is caused from a broad range of factors such as cross contamination (other pharmaceutical active ingredients), cleaning agents and micro-organisms.
Additionally, the risk of contamination may in some cases be from a calculation error which results in choosing the wrong Maximum Carry-Over Limit (MAC). For example, can you consider the number of calculations required for an equipment train, with twenty (20) sample points, having different surface areas (swab sample area), different sampling types (swab/rinse), five (5) products manufactured on the equipment train, and each product has ten (10) production stages, and two (2) different cleaning agents are used. There is a huge risk associate with calculating the Maximum Carry-Over Limit (MAC) manually.
Automation has played a key role in decreasing risks associated with various processes. Data integrity is an important component of the industry’s responsibility to ensure the safety, efficacy and quality of pharmaceutical products.
Other Cleaning Validation Highlights Include:
- Cleaning Validation Considerations for Multi-Product Transfer to a Consolidated Manufacturing Facility
- Lifecycle Approach to Cleaning Validation
- Establish a Compliant Disinfectant Efficacy Program
- Cleaning Inspection Readiness
- Cleaning Validation Documents Overview and Applications
- Senior-Level Think Tank —Can Cross-Contamination Be Prevented?
Save $300 on your registration with our sponsored PROMO CODE: JAN846