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1 of 5 Welcome Note by Roohi B. Obaid

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Page 1: 1 of 5 Welcome Note by Roohi B. Obaid
Page 2: 1 of 5 Welcome Note by Roohi B. Obaid

Thank you of worthy guests, AuVitronics & HabibUniversity for time and great support

Page 3: 1 of 5 Welcome Note by Roohi B. Obaid

Special thanks to Mr. Muhammad Noman & Ms. AlmasAltaf for their kind assistance in organizing the program

Page 4: 1 of 5 Welcome Note by Roohi B. Obaid

Professionals of different

departments from leading companies

Professionals of diverse educational background from

different institutions

Platform of rich

experienced people

Page 5: 1 of 5 Welcome Note by Roohi B. Obaid

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

Page 6: 1 of 5 Welcome Note by Roohi B. Obaid

Creating the Culture of Quality

Sultan Ghani

Page 7: 1 of 5 Welcome Note by Roohi B. Obaid

Quality A lifestyle for Success

Iftikhar A. Jafri, Ph. D.

Page 8: 1 of 5 Welcome Note by Roohi B. Obaid

Quality Metrics & Science

Obaid Ali, Ph. D.

Page 9: 1 of 5 Welcome Note by Roohi B. Obaid

Expert Panel Forum for Discussion on Quality Affairs

Engineering Mfg Testing Quality Regulatory

Page 10: 1 of 5 Welcome Note by Roohi B. Obaid

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

Page 11: 1 of 5 Welcome Note by Roohi B. Obaid

Lets open the day with a hypothetical case

Page 12: 1 of 5 Welcome Note by Roohi B. Obaid

34 week

NICU

RSV

Vaccine not available due to contamination

issue

Page 13: 1 of 5 Welcome Note by Roohi B. Obaid

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

Page 14: 1 of 5 Welcome Note by Roohi B. Obaid

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 ?

Page 15: 1 of 5 Welcome Note by Roohi B. Obaid

Thank youHave a very good day