PDA Missouri Valley Chapter Webinar: Cleaning Validation – Sterile Environments Regulatory Trends
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Are you interested in finding out more about the latest trends in an FDA inspection process and the impact of findings? Moreover, are you interested in finding how to be better prepared as an internal stakeholder for the inevitable inspection?
You are invited to join us for a free informative webinar, led by Beth Kroger, Technical Services Senior Manager for the Life Sciences Division of STERIS Corporation. At the end of this webinar, attendees will gain increased knowledge on trends in FDA Inspections. We look forward to your participation on June 24th at 11:00 am (CDT).
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.
More information coming soon.
Day 1
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
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