Approaching unknown cause laboratory investigations using lean tools 2018

Approaching unknown cause laboratory investigations using lean tools 2018 is an event dedicated to requirements for investigations when dealing with pharmaceutical drug substances and products etc.

Topics

• CFR 210 & 211 requirements for investigations.
• ICH guidelines for investigations.
• Initiation of an investigation.
• Relevant lean tools.
• Finding acceptable resolution.
• Controlling the scope of an investigation.
• CAPAs.

Who should Attend

• QC testing groups
• QC functions in general
• QA reviewers and investigators
• QC investigation groups
• Management teams who need to understand investigational pathways
• Manufacturing personnel who support investigations