1 of 5 Welcome Note by Roohi B. Obaid
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Transcript of 1 of 5 Welcome Note by Roohi B. Obaid
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Thank you of worthy guests, AuVitronics & HabibUniversity for time and great support
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Special thanks to Mr. Muhammad Noman & Ms. AlmasAltaf for their kind assistance in organizing the program
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Professionals of different
departments from leading companies
Professionals of diverse educational background from
different institutions
Platform of rich
experienced people
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Special thanks to Mr. Ajaz Hussain, former Deputy Director US-FDA, Mary Oates, VP Global Quality at
Pfizer etc. for technical support
Documents/articles referred from ISPE, PDA, Harvard & US-FDA
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Creating the Culture of Quality
Sultan Ghani
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Quality A lifestyle for Success
Iftikhar A. Jafri, Ph. D.
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Quality Metrics & Science
Obaid Ali, Ph. D.
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Expert Panel Forum for Discussion on Quality Affairs
Engineering Mfg Testing Quality Regulatory
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Expert Panel Forum for Discussion on Quality Affairs
Every expert will speak for 5-10 min
Kindly ask 15-20 sec question, avoid comment please
Please add comment to explain or respond to any question under discussion
What
WhyHow
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Lets open the day with a hypothetical case
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34 week
NICU
RSV
Vaccine not available due to contamination
issue
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Newborn transferred to
NICUHospital of great care
Vital signs are monitored constantly
Susceptible to infection of
RSV
Because lungs have not
developed
Unluckily vaccine is not
available
Respiratory Syncytial Virus
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RSV vaccine(Sole asset in class product)
Problem at manufacturing
site
Bulk mammalian cell (DS production)
Difficult to clear contamination from murine
retrovirus
Math Who will solve the math of human life ?
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Thank youHave a very good day