Dr. Klaus Pittertschatscher
Head of Quality Assurance Corporate Q.P.
PAA Laboratories
2005 - present: Head of Quality Assurance / QC and Qualified Person in accordance with the EU GMP Guide of PAA Laboratories GmbH, Linz.
2004 – 2005: Projectmanager Validation, QA/QC, LSMW GmbH, Stuttgart
2002 – 2004: Manager, Head of Quality Control-Coagulation; Coagulation Testing – Laboratories (2), Immunological and Serological – Laboratory, Pharmacological – Laboratory, Standard and Reagents Laboratory (1), Method Development Laboratory; Baxter AG, Vienna.
(Responsibilities: Release testing of all plasma products, standards and reagents and method development. Negotiations with authorities (PEI, BIFA, NIBSC, FDA).)
2001 – 2002: Validation Coordinator, Quality Control Chromatography, Baxter AG, Vienna
1992 – 2000: University Assistant at the Paris-Lodron-University, Development of bioanalytical methods (e.g.: Plasmid DNA, Endotoxin, Histamine in plasma of allergic mice, ELISA to determine the Propyphenazone specific IgE level of allergic patients)
Kadariah Mohd Ali
Principal Assistant Director/ GMP Lead Auditor, Centre for Compliance and Licensing National Pharmaceutical Control Bureau
Ministry of Health Malaysia
Ms Kadariah Mohd. Ali is a Registered Pharmacist / Principal Assistant Director and one of the GMP Lead Auditors at the Centre for Compliance and Licensing of National Pharmaceutical Control Bureau of Malaysia’s Ministry of Health. She obtained her first degree i.e. Bachelor of Pharmacy (Hons) from University of Science in Malaysia and her Master of Science at the University of Bradford in United Kingdom.
Between 1983 and 1992, she served in various hospitals in Malaysia and was the Head of the Pharmacy Department at Malaysian Pilgrims Hospitals in Medina, Mecca and Jeddah, Saudi Arabia in 1992.
At the early stage of her career in 1991 to 1993 at the National Pharmaceutical Control Bureau (NPCB), Ms Kadariah Mohd. Ali was one of the officers in-charged of product recall under the post market surveillance programme. She was then involved in the registration of traditional medicines as an evaluator until 1994. Her involvement in GMP inspection activities began in 1995 which covers inspection of local and foreign pharmaceutical manufacturers. Apart from inspections, she actively participates as a speaker in various training sessions related to GMP including courses, workshops and seminars conducted by pharmaceutical, traditional and cosmetic industries in Malaysia. She was a visiting lecturer in Quality Assurance Modules at the Faculty of Medicine (Pharmacy Department) at University of Malaya between 2003 and 2004.
In 2005 she was appointed as a Senior ASEAN Expert for Pharmaceuticals assisting ASEAN countries in upgrading the quality system of GMP inspection and licensing under the EC-ASEAN Economic Co-Operation Programme. Since 2007, she has been actively involved in activities to improve GMP compliances by the producers of radiopharmaceutical products including the public and private hospitals in Malaysia. Since then, she has been appointed as one of the consultants by the International Atomic Energy Agency (IAEA) for preparing regulatory policies and procedures for producing radiopharmaceuticals.
Ms Kadariah Mohd. Ali was also involved in the accession of Malaysia into the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2001 and from then on she had taken part in the joint inspections with GMP inspectors from various countries such as Sweden, Canada, Australia, France, Taiwan, Greece, Switzerland, Norway, Denmark, Argentina and United Kingdom which was held either in Malaysia or abroad
Mai Tuyet Ong
Senior GMP Auditor
HSA
Mai Tuyet Ong (or Mai as she prefers to be called) is currently joins HSA as a Senior GMP Auditor and she has been in the pharmaceutical industry for the last 10 years. She holds a Master degree Analytical Chemistry and Instrumentation. Mai area of expertise is testing and releasing of manufacturing product under GMP environment. Prior to joining HSA, Mai has worked in GlaxoSmithKline, Singapore, as an Analytical Chemist. GSK was the first company that Mai worked for when she arrived in Singapore. During her 8 years with GSK, her responsibilities included the leading and supervising of a team of Analysts, performing QC tests, analyzing, interpreting and verifying analytical results of finished products, intermediates and starting materials. Before coming to Singapore, Mai worked as a Chromatography Chemist for 2 years with AstraZeneca, UK and her main responsibilities was developing chromatographic methods in support analysis of research products.
Premnath Shenoy
Regulatory Afffairs Director
AstraZeneca India
Premnath Shenoy, PhD, with over 20 years experience in Pharma Quality assurance & Regulatory Affairs working at present as Regulatory Affairs Director with AstraZeneca India.
Syed F. Huda
Quality Head
Reckitt Benckiser Pakistan
Mr. Syed F. Huda has been trained and educated abroad, completing his MS in Industrial Pharmacy from The University of Toledo, Ohio, USA. He has more than 20 yrs of working experience in Pharmaceutical industry both in USA and Pakistan and holds patents in USA and Europe on slow release techniques. He was responsible for commissioning and successfully running the PharmEvo Private Limited factory at Port Qasim, Karachi Pakistan and developing a quality oriented team. Mr. Huda possess diverse training/experience in manufacturing, QA/QC, regulatory, drug laws, product development, line extension, formulation development, process & method development, R&D, factory administration, operations, supply chain, process & method validation, plant design & maintenance, engineering projects, and risk management. He has exposure to Quality improvement tools and has completed KIAZEN & MUDA projects. He is an experienced GMP auditor and certified lead auditor for ISO 9001–2000. Mr. Huda is currently working as Quality Head in Reckitt Benckiser Pakistan looking after quality of Pharma as well as consumer goods.
Dr. Mithilesh Trivedi
Vice President – QA & QC
Calyx Chemicals & Pharmaceuticals Ltd
Mithilesh Trivedi has completed his Ph. D. from UDCT (presently known as UICT), Mumbai. He has over 25 years of extensive experience in the area of Research & Development, Quality Assurance & Quality Control, and Manufacturing & Operation in Chemical; Fine Chemical; Bulk Drugs and Formulation Industries. He also has extensive experience in product development, process optimization & control, standardizing production norms, chemical lab practices and supplier technical assurance. Mithilesh was also actively involved in analytical method validation and demonstrated excellence in managing training & development operations. His knowledge also lies in that of maintenance, calibration and troubleshooting of analytical equipment to enhance productivity. Lastly, Mithilesh has also experience in Sterility Pyrogen including BET (LAL Test) and Toxicity Testing and he ensured compliance of various quality measures by maintenance of appropriate requisite documentation/ records.
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