The FDA conducted approximately 17,671 inspections in Fiscal Year 2018, amounting to roughly 1400 inspections/month resulting in 14,482 compliance actions (warning letters, injunctions, and seizures) and ~4,900 inspectional 483 observations.
Attendees will better understand the inspection process and the role of the internal stakeholders during an FDA inspection surrounding critical environments such as sterile environments and cleanrooms and cleaning process equipment/Cleaning Validation.
To ensure inspection readiness, as it relates to a validated cleaning process, the speaker will address the following:
- Current regulations, guidance and FDA expectations related to Cleaning Validation
- Review changes in draft Annex 1
- Review current findings from Regulatory inspections and identify trends relevant to Cleaning Validation
- Current industry perspective, trends, and best practices
- Where to focus attention for upcoming inspections – avoid scope creep
- Provide insight from her own experience and detail how to shore up your CV program and manage your regulatory inspection
Based in the USA, Beth specializes in cleaning validation and cleanroom environmental control. She frequently speaks on these topics for ISPE, PDA, as well as University Masters programs. Her background includes over 25 years-experience in Biopharmaceutical and Oral Solid Dose manufacturing where she has held positions in R&D, Operations Management, Compliance, Cleaning Validation, and Technical Transfer.
She is an Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program for the Spring semester, 2020, and most recently, Beth was a member of the ISPE committee responsible for drafting the current Cleaning Validation Good Practice Guide (GPG).