Leading industry experts will address the latest regulatory updates and technological developments
Pharmig’s 19th Annual Conference covering latest updates and hot topics in microbiology will take place on 16 –17 November 2011 at The Nottingham Belfry Hotel, Nottingham, UK.
The conference will consist of two packed days of research-led topics key to everyday working practices, during which nine leading experts will share their knowledge and expertise. Four open discussion sessions will allow delegates to extend their networking experience in a more informal environment.
Alongside the conference, 24 exhibitors will demonstrate future industry trends and technologies and innovative solutions to current pressing industry issues. The conference will also incorporate Pharmig’s AGM and all members are encouraged to attend.
The keynote session will focus on recent issues and observations during EU GMP Inspections, featuring issues with reference to microbiology labs and outcomes/results; common GMP failing points; and overlooked regulations. The speaker will be Neil Raw – GMP Inspector, MHRA.
Amy McDaniel, director, QC Microbiology at Pfizer (USA), will offer a case study on sustaining a lean QC Microbiology laboratory, covering the challenges encountered moving from implementation to sustainability; tools for sustaining lean product testing and environmental monitoring; and key performance indicators for the QC microbiology laboratory.
A risk-based approach for determining objectionable micro organisms, including who should be involved in determining whether an organism is objectionable, will be addressed by Dr Stephen Rawlings – principal microbiologist, GlaxoSmithKline, and Dr Tim Sandle – company microbiologist, BPL, will give delegates a rapid walkthrough of regulatory and compendial developments over the past 12 months.
Advances in microbial identification and why traditional approached are now changing will be covered by Sarah Wallis – registered specialist biomedical scientist, Microbiology Dept Northern General Hospital, Sheffield Teaching Hospitals NHS
Foundation Trust, and Tim Eaton – sterile manufacturing specialist, AstraZeneca, will discuss risk management of contamination during cleanroom operations.
On the second day of the conference Raw will address the issue of sterility failure, how to investigate what went wrong and develop an appropriate SOP, followed by a look at the role of the manufacturing plant microbiologist from Scott Smith – microbiology QC leader, Sanofi-Aventis.
David Keen, supply microbiology manager, Reckitt Benckiser, will outline best practices for performing contamination investigations, and Stewart Green, managing director, GXP Consulting, will talk to delegates about how to justify doing less monitoring, sampling and testing and still pass an inspection.
Finally, the topic of developing a meaningful environmental monitoring programme for sterile/non sterile products will be addressed by Dr Julia Mottishaw – QP, Teva Runcorn.
Pharmig is the influential forum for microbiology in the pharmaceutical, healthcare and allied industries. A non-profit making organisation established in 1991, it represents the interests of individuals who work in, have responsibility for, or work alongside microbiology and provides a focus for continuing professional development and a unique opportunity for the exchange of microbiological information.
It organises meetings, training courses, site visits and conferences that provide topical information and views on microbiology-related topics. Its aims are to advance the science of microbiology and its practical application; seek to influence the development of regulations and guidelines and GMP surrounding microbiology; and act as a confidential forum for dissemination of information concerning all aspects of microbiology.