Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L....
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![Page 1: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/1.jpg)
Lynda Paleshnuik | May 20141
Copenhagen Workshop May 2014
Session outlines
and objectives
L. Paleshnuik
Lead Quality Assessor
PQT
![Page 2: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/2.jpg)
Lynda Paleshnuik | May 20142
Schedule of talks
Day 1• Prequalification: Overview and update • Bioequivalence• WHOPARs and labeling • Quality assessment principles: Part I • API assessment: impurities• Specifications
![Page 3: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/3.jpg)
Lynda Paleshnuik | May 20143
Schedule of talks
Day 2• Packaging• Quality assessment principles: Part II • Pharmaceutical development• Process validation • Stability assessment: API and FPP• Collaborative procedure
![Page 4: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/4.jpg)
Lynda Paleshnuik | May 20144
Schedule of talks
Day 3• Assessing batch records • GMP issues in quality assessment
![Page 5: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/5.jpg)
Lynda Paleshnuik | May 20145
Your participation
Days 1 and 2• Open discussion/Q&A on the day’s topics • Participate in the exercises/discussions • Ask questions during/after talks or at the end of the day, • Collect questions for your one-on-one session
![Page 6: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/6.jpg)
Lynda Paleshnuik | May 20146
Questions
Questions are good• The speaker will say if questions should be held for the end of their talk • Please speak slowly when posing Qs• Questions can be given to any of the facilitators, to be handled at end of day• A speaker may defer a complex question
![Page 7: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/7.jpg)
Lynda Paleshnuik | May 20147
Your participation
Day 3• Fill out the workshop evaluation(Very important)• One-on-one breakout sessions (feedback and guidance)
![Page 8: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/8.jpg)
Lynda Paleshnuik | May 20148
Your participation
Day 4• Written exam• Workshop wrap-up and final close
![Page 9: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/9.jpg)
Lynda Paleshnuik | May 20149
CTD
Common technical document
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Lynda Paleshnuik | May 201410
Acronyms!
API – active pharmaceutical ingredient
BCS – biopharmaceutics classification system
COA - certificate of analysis
CTD – common technical document
EC – enteric coated
ER – extended release
FDC – fixed dose combination
FPP – finished pharmaceutical product
GC – gas chromatography
![Page 11: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/11.jpg)
Lynda Paleshnuik | May 201411
Acronyms!
ICH – international conference on harmonization
NMRA – national medicines regulatory authority
PhInt – International Pharmacopoeia
PQ/PQT – Prequalification of Medicines Team
PSD – particle size distribution
QA – quality assurance
QRM – quality risk management
SPC/SmPC – summary of product characteristics
![Page 12: Lynda Paleshnuik | May 2014 1 Copenhagen Workshop May 2014 Session outlines and objectives L. Paleshnuik Lead Quality Assessor PQT.](https://reader035.fdocuments.in/reader035/viewer/2022062404/551aa0e0550346e0158b58d8/html5/thumbnails/12.jpg)
Lynda Paleshnuik | May 201412
Acronyms!
SST - system suitability testing
TRS – WHO technical report series publication
WHOPAR – WHO public assessment report
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Lynda Paleshnuik | May 201456
Questions?
Questions?