Avoid 483 citations for out-of-specification (OOS) results and other QC laboratory controls issues by having this handy FDA Lab Controls Compliance Answerbook in your regulatory/quality library.
ALL in ONE PLACE FOR YOUR REVIEW!
Get more than 600 pages of FDA and EMA rules, guidance documents, compliance guides and additional assistance so you can ensure you can show inspectors you are in compliance.
The book includes, BUT not limited to the following:
* FDA guidance on OOS
* FDA Laboratory Procedures Manual used by its Office of Regulatory Affairs to inspect drug and biologics facilities
* FDA and ICH guidance on analytical methods related to labs
* Applicable CMC documents
* USP document titles to help you be in compliance
* Sample inspection reports on recent 483 and EIR citations for QC lab issue
SPECIAL SECTION ON Quality Metrics and Data Integrity in FDA inspections.
PLUS, DVD of major FDA inspection guides and international documents on lab controls!
The FDA Lab Controls Compliance Answerbook costs $695 plus shipping. Books to be shipped by October 2017.
Avoid 483s and enforcement hassles for lab non-compliance. Get this important FDA compliance manual today!