Risk Based Approach to Cleaning Validation & FDA Compliant Aseptic Processing & Environmental Monitoring Event – New Brunswick New Jersey USA
Novatek International was proud to have sponsored yet another successful Global Biopharmaceutical Resources, Inc. (GBPR, Inc.) event last week in New Brunswick NJ. Such a successful event was due in part to an impressive attendance of high expertise attendees and a variety of knowledgeable presenters. Interactive discussions were openly shared throughout the three day event addressing a variety of appropriate topics that are in line with today’s current industry trends in improving an organization’s overall quality standard and cGMP compliance.
Daily Presentation Highlights:
DAY 1: Areas to Consider When A Regulatory Inspector “Knocks” on Your Door:
Strategies that an organization should follow as well as those that should not be followed in preparation of meeting the requirements of an FDA audit.
Presented by Barry Friedman, Ph.D., LLC
Barry Friedman shared insights on developing an environmental plan for controlled environments. Amongst several excellent points was the focus on developing a good facility design as this would eliminate many potential CAPAs. During FDA audits, the number one instigator for warning letters is CAPA-related issues. Once a good design is in place, establishing design reviews will help to ensure having a high quality operation in place.
DAY 2: Viable Environmental Monitoring:
A Review of Current Regulations, Standards and Guidance and Proposed Changes to ISO 14698-1,2 and USP <1116>
Presented by: Carolyn C. Phillips, Microbiology Consulting Services
Various regulations were reviewed and interpreted during Carolyn’s presentation, Here is one highlight: An interesting concept brought forth by the USP 1116 proposed revision was contamination recovery rates. It suggests establishing your alert/action levels based on these rates which are essentially percentages based on your growth numbers, as opposed to using discrete numbers. Companies need to be able to detect changes in these rates and act on any notable increases. The USP is currently open for comments.
DAY 3: Environmental Monitoring Software User Requirements CFR Part 11 & Annex 11
Presented by: Susan Cleary, Novatek International
21 CFR Part 11 regulations were discussed and an interpretation provided as to how they can be applied onto microbial environmental monitoring software. What consists of a truly 21 CFR Part 11 compliant software, and what security and controls are necessary in compliance with these regulations. How does it affect software performance, flexibility and user-friendliness? Susan Cleary was able to answer these questions with many relevant examples.
Novatek International will also be sponsoring GBPR Inc.’s June 2011 Events. For more information on the highly educational topics to be discussed please visit: www.gbprinc.com.