1 of 5 Welcome Note by Roohi B. Obaid

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

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

Professionals of different

departments from leading companies

Professionals of diverse educational background from

different institutions

Platform of rich

experienced people

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

Creating the Culture of Quality

Sultan Ghani

Quality A lifestyle for Success

Iftikhar A. Jafri, Ph. D.

Quality Metrics & Science

Obaid Ali, Ph. D.

Expert Panel Forum for Discussion on Quality Affairs

Engineering Mfg Testing Quality Regulatory

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

Lets open the day with a hypothetical case

34 week

NICU

RSV

Vaccine not available due to contamination

issue

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

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 ?

Thank youHave a very good day