ISPE at BioMalaysia 2014
It was with great pleasure that the Malaysia ISPE Affiliate was invited to organize a track at this
year’s annual BioMalaysia conference: BioEconomy Asia Pacific 2014. This year BioMalaysia was at a
different venue from the usual conference centre; it was held at the Research Management and
Innovation Complex, University Malaya, which proved to be a great choice of venue for a
biotechnology conference. But the best thing – both the session and workshop were free!
ISPE Malaysia organized two events during the conference, both on the second day; a session entitled
“Biopharmaceuticals – The Different Phases of Bringing a Biopharmaceutical Drug to Market” and a
workshop “Introduction to Computer Validation and GAMP®.”
The session involved three expert speakers discussing a range of topics and was moderated by the
Malaysia Affiliate President, Mr. Azhar Hussain.
The first speaker, Mr. Jay Padasian from Malaysian Biotechnology Corp., presented an
“Overview of the BioMedical Industry.” Jay told us about the global biomedical industry and then
provided detailed information on Malaysia’s growing biotechnology industry, including some of the
international companies that have invested in Malaysia recently such as Biocon and Stelis
Biopharma, both in the BioXcell Park.
The second speaker, Ms. Michelle Peake from Synertec Asia, managed to squeeze in the
topic of “Biomanufacturing Facility Design” into 20 minutes. Michelle touched on some general
design considerations when building any type of facility and then spoke about design considerations
for a biomanufacturing facility that she had helped design.
The final speaker of the ISPE session, Mr. Steve Slater of TRAQuE Singapore, gave a
presentation on “Current Developments in Cold Chain Management.” Steve gave a very interesting
and informative session drawing on his experience and showing examples from a company that he
had been working with in China.
We held a workshop in the afternoon conducted by Dr. Anthony Margetts from FactoryTalk entitled
“Introduction to Computer Validation and GAMP®.” The speaker covered topics on History of CSV,
PIC/s CSV Guidance, Overview and Importance of CSV and Introduction to GAMP®, Risk Assessment in
CSV and How to Develop a URS and Validation of Different Types of Systems.
This was a great event held by the Malaysia Affiliate; many thanks to all involved who gave up their
spare time to prepare extremely informative presentations and to the people behind the
scenes who helped put it altogether in such a short amount of time. Please remember to check the
Malaysia Affiliate Facebook page for our upcoming events – you don’t want to miss out – especially
the free ones!!!