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2021 - Reviewing Drug Product Batch Records

Date2021-02-08

Deadline2021-01-29

VenueOnline event, USA - United States USA - United States

KeywordsPharmaceutical production; Quality by design; Batch record review

Websitehttps://www.complianceonline.com/reviewi...

Topics/Call fo Papers

Regulatory requirements for batch review (EU and US)
Important areas to check in batch records
Common errors
Examples of deficiencies leading to regulatory enforcement action
Overview of the draft ICH Q12 guidance
ICH Q12 and Quality by Design
Benefits of continuous improvement
Approaches to data trending

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Last modified: 2021-01-28 01:03:41