Pall Biotech has announced it is participating in a webinar titled ‘Finding the Common Road to Quality for Single-Use Materials’.
Good manufacturing practice (GMP) requirements touch every single-use assembly, from those used in clinical studies to those used in commercial manufacturing. Following GMP when producing single-use assemblies ensures that there is no risk to patients in clinical trials and future commercial products.
If we can’t prove GMP, single-use assemblies will not be accepted by regulatory agencies and internal quality departments as an alternative to stainless steel tanks. In addition, the perception will continue that there are inadequate quality controls on single-use assemblies, as GMP practices are not adequately followed.
Taking place on 6 June at 9:00am PST, the webinar will include speakers from Genentech and Pall Biotech. It will be presented by senior quality control scientist Dr Trishna Ray-Chaudhuri, who is an integral part of the direct materials in global analytical sciences and technology team at Genentech, a wholly owned subsidiary of Roche in South San Francisco, California, US.
Since 2011, she has been responsible for supporting the implementation of single-use systems in terms of system performance and reliability through specification development. Before joining Roche, she was an independent consultant providing support in the development of single-use systems. Prior to this, she was senior process engineer at Sartorius-Stedim working in the development and implementation of single-use systems. Trishna started her career in Monsanto Plastics prior to its acquisition by Bayer.
Trishna has a Postgraduate Doctoral Degree (PhD) and a Master’s Degree (MS) in polymer engineering from the University of Tennessee and a Bachelor of Science degree (BS) in chemical engineering from Rutgers College of Engineering.
The webinar will be presented by Dr Hélène Pora and Dr James Hathcock of Pall Biotech. Dr Hélène Pora is vice-president of single-use technology, where she has the global responsibility for the marketing and development of Pall single-use technologies.
Hélène has been instrumental in the development of Pall single-use technologies for the last 20 years. She is also heavily involved in quality and regulatory aspects of single-use technology. Hélène has more than 30 years of experience working in the biopharmaceutical industry, as well as 26 years with Pall Corporation.
She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different working groups in the industry involved in standards development and is on the board of the Bio-Process Systems Alliance (BPSA) and the Single-Use Technology Assessment Programme (SUTAP).
Dr James Hathcock is senior director of the regulatory and validation consulting team at Pall Life Sciences, which includes a responsibility for the extractables and leachables characterisation strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing.
He is an active member of American Society for Testing and Materials (ASTM), Parenteral Drug Association (PDA), the International Society for Pharmaceutical Engineering (ISPE), BPSA and the United States Pharmacopeia (USP) <665> expert panel.
Since joining Pall in 2008, James has led chemical and performance characterisation of medical and biopharmaceutical products, as well as relevant technical packages supporting regulatory filings. Prior to joining Pall, James was a professor of haematology at the Mt Sinai School ofMedicine in New York City, where he served as director of the protein purification core laboratory.
To take part in this webinar, register at biopharma-asia.com/webinars or make an enquiry using the form on this page.