Prequalification: Training Workshop

The 3rd annual Prequalification assessment training

       Copenhagen, Denmark,  19 - 22 January 2011

• Agenda

Wednesday, 19 January 2011

• Training session outline and objectives  [ppt]

• Prequalification overview and update of PQP  [ppt]

• The new PQP quality guidelines  [ppt]

• API assessment: approaches and considerations  [ppt]

• QIS/QOS: the new PQP quality templates  [ppt]

• Impurities: establishing specifications (Q3A/B, qualifications, etc.)  [ppt]

• The ICH Q8 "Minimal approach" to pharmaceutical development  [ppt]

Thursday, 20 January 2011

• Dissolution case studies  [ppt]

• Supporting documents for assessment - SUPAC  [ppt]

• FPP assessment: approaches and considerations  [ppt]

• Method and validation basics - HPLC case study  [ppt]

• Formulation development issues: solid orals  [ppt]

• Stability  [ppt]

Friday, 21 January 2011

• GMP lessons for quality review  [ppt]

• Assessing production documents: executed and master records  [ppt]