Pharmaceutical microbiology west coast
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SMi will host the 7th Pharmaceutical Microbiology West Coast conference on June 8-9, 2017 in San Diego, USA. The conference will address current challenges in sterility assurance, environmental monitoring, and rapid microbial methods. Over the two days, experts from companies like GSK, Amgen, Janssen, and Takeda will discuss topics like environmental monitoring trends and data analysis, challenges in endotoxin testing and sterility assurance, case studies on contamination control, and the validation and use of rapid microbial methods. Workshops on the day before will cover technologies for monitoring contamination control and case studies, as well as microbial requirements for terminal sterilization.
Pharmaceutical microbiology west coast
- 1. KEY BENEFITS FOR 2017: • Discuss the challenges involved with microbial control with Takeda • Following the path to efficient sterility assurance with GSK • Bimeda highlight the importance of environmental modelling • Delve into the latest developments in rapid microbial methods with Janssen • Hear the latest on data integrity and compliance with Roche SMi present the 7th in its series... Hyatt Regency Mission Bay, San Diego, USA Addressing the current challenges in sterility assurance, environmental monitoring and RMM whilst evaluating the latest trends and opportunities for microbial control. WORKSHOPS: 7TH CONFERENCE: 8TH - 9TH JUNE 2017 REGISTER BY 31ST MARCH AND SAVE $200 REGISTER BY 28TH APRIL AND SAVE $100 www.pharma-microbiology-usa.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 ACADEMIC & GROUP DISCOUNTS AVAILABLE @SMIPHARM #smimicrobiology PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS Wednesday 7th June 2017, Hyatt Regency Mission Bay, San Diego, USA Technologies for Monitoring Contamination Control and Case Studies on Contamination Control 08.30 – 12.30 Workshop Leaders: Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation Andrew Bartko, Research Leader, Battelle Memorial Institute Microbial Required Use for Terminal Sterilization 13.30 – 17.30 Workshop Leader: Jerry Dalfors, Principal, JD Technologies Pharmaceutical Microbiology West Coast Sponsored by CHAIRS FOR 2017: • Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK • John Duguid, Senior Director, Research & Development, Vericel Corporation EXPERT SPEAKER PANEL INCLUDE: • Ron Smith, Director, External Supply Integration Quality, Janssen • Ren-Yo Forng, Scientific Director, Amgen • Kevin Luongo, QC Sr. Scientist (Microbiology), Takeda • Lina Orjuela, Microbiologist, Merck • Paul Ricciatti, Sterility Assurance Manager, Bimeda • Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting • Akua Gilbert-Arthur, Principal Scientist, Roche Molecular Systems
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Pharmaceutical Microbiology West Coast Day One | Thursday 8th June 2017 www.pharma-microbiology-usa.com 08.30 Registration & Coffee 09.00 Chairman’s Opening Remarks Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK OPENING ADDRESS 09.10 Retracing the path to sterility assurance: An USP journey • Update on latest revisions of USP microbiology chapters • Discussion of work activities for revising chapter on sterility assurance • Current thinking about sterile product evaluation topics (bacterial endotoxins testing, alternative pyrogen test, container closure integrity evaluation, sterility test) Donald Singer, GSK Fellow, Steriles Microbiology, R&D, GSK ENVIRONMENTAL MONITORING 09.50 The importance of environmental monitoring • Environmental monitoring in today’s pharmaceutical industry is imperative to avoid potential risks to consumers and to save time and cost to manufacturers • Rules governing dispersion of airborne microbial contaminants and how contaminants can accumulate in invisible vortices and airborne contamination • How to evaluate representative sampling locations for environmental monitoring during aseptic processes Paul Ricciatti, Sterility Assurance Manager, Bimeda 10.30 Morning Coffee 11.00 Environmental monitoring trend analysis tools • The importance of proper analysis and evaluation of viable EM results. • Development of a “tool box” in order to produce specialized data reports. • A case study in using the correct tools to demonstrate environmental control in a cleanroom environment Steve Walton, Technical Manager, Sterility Assurance, Sanofi 11.40 Gram negative LPS structural alterations in response to environmental stimuli • Overview of how gram negative bacteria adapt to various environmental conditions • The role of modulation of outer membrane components has on facilitating environmental adaptation • The effect of external stimuli and structural adaptation has on the classical LPS architecture John Dubczak, Director of Operations, Charles River 12.20 Networking Lunch CHALLENGES IN ENDOTOXIN RECOVERY & STERILITY ASSURANCE 13.20 Challenges in endotoxin testing • Advantages of in-process control • Issues occurring in the detection of endotoxins • Utilising the alternative endotoxin reagents and/or methods to detect potential contaminants in products Ren-Yo Forng, Scientific Director, Amgen 14.00 Interactive extended training session: Effects of cleanrooms and barrier systems on environmental monitoring data Recent warning letters show that manufacturers of aseptic products are receiving the most 483s; many are related to smoke studies. Smoke / Airflow Visualization tests are often performed by third party certifiers. However, per FDA guidance, dynamic in-situ air pattern analysis is more complex. These studies should be investigative and effective at identifying design flaws or airflow issues. They should be performed using the correct type of smoke, smoke density, and camera angles. • A closer look at existing regulation (e.g. Pharm. Eur., USP, PDA) • Why do we need to implement rapid microbial methods vs classical microbial methods? • How to evaluate the best RMM for each application • Validation strategy, regulatory strategy and examples of return of experiences Morgan Polen, Subject Matter Expert on Contamination Control, Microrite 15.00 Afternoon Tea 15.30 Bringing the cleanroom online after an adverse event • Environmental control of classified areas within a biopharmaceutical facility - maintained by systems controlling humidity, air temperature, air exchanges, filtration and pressure differentials • When any of these systems or practices fail, it’s considered a “Worst Case Event” which has the potential to impact the clean state of a Classified Area • FDA Warning Letters and 483s will be covered that focus on cleanroom shut down and start up procedures Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting 16.10 Microbiological examination of non-sterile products • Experience with USP <61> and USP <62> tests • Utilising these test to provide harmonization with the European Pharmacopeia methods • Challenges incurred and lessons learnt Elizabeth Hulanick, Microbiologist, Renaissance Pharmaceuticals 16.50 Chairman’s Closing Remarks and Close of Day One Sponsored by Register online at www.pharma-microbiology-usa.com SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: [email protected] bioMérieux Inc Like you, we are inquisitive microbiologists who rely on our experience to explore and innovate ways to keep your lab running smoothly and ensure that your products are safe. Visit www.thepeoplebehindthescience.com to see what new science our people are creating for you. Together, we are the people behind the science. Charles River Protecting the integrity of your products requires a reliable partner at all critical junctures in the QC process. We’ve purposely built our portfolio to bring you progressive products and services that deliver accurate, relevant and reliable data to fuel confident decisions on product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture and protects your reputation. www.criver.com/products-services/manufacturing-support Rapid Micro Biosystems delivers the Growth Direct™ System, an automated, non-destructive rapid detection and enumeration technology based on the compendial method for microbial quality control in pharmaceutical manufacturing. The system automates and accelerates detection and enumeration in the areas of environmental monitoring, bioburden and sterility testing eliminating manual steps and analysis. The Company’s Growth DirectTM System detects contamination earlier, delivering compelling economic benefits to manufacturers, while improving their quality process. The Growth Direct System is the first and only automated system that addresses all key microbial QC applications and fits with current regulatory practices, a critical accelerator for adoption. Automated analysis eliminates error-prone manual steps and saves labor; rapidly detecting contamination enables manufacturers to reduce inventory carrying costs, shorten manufacturing cycle time, and reduce product losses, delivering significant cost savings and increased operational efficiency. www.rapidmicrobio.com
- 3. Pharmaceutical Microbiology West Coast www.pharma-microbiology-usa.com Day Two | Friday 9th June 2017 08.30 Registration & Coffee 09.00 Chairman’s Opening Remarks John Duguid, Senior Director, Research & Development, Vericel Corporation RAPID MICROBIAL METHODS OPENING ADDRESS 09.10 Challenges involved with microbial control • A CMO-focused microbial control strategy • The challenges with managing an external manufacturing program • Looking to the future Kevin Luongo, QC Sr. Scientist (Microbiology), Takeda 09.50 Validation of a Rapid Microbial Method: Case studies for microbial limits and sterility testing. • Overview of the approach for testing equivalence of a qualitative method • Demonstrating equivalence to pour plate method for Microbial Limits testing of betamethosone suspension • Demonstrating equivalence to membrane filtration sterility test method for a saline product Ronald Smith, Director, External Supply Integration Quality, Janssen 10.30 Morning Coffee 11.00 US approval of three rapid microbiological methods for MACI product release • Same day product release is needed for MACI® (autologous cultured chondrocytes on porcine collagen membrane) • Automated rapid microbiological methods enable test results within hours • Regulatory requirements are continuing to evolve John Duguid, Senior Director, Research & Development Vericel Corporation DATA INTEGRITY 11.40 Data integrity and compliance • Current limitations with data integrity • How to improve the reliability of data is necessary to support clinical trials, product development and manufacturing, and testing and reporting requirements • Examining data integrity in relation to related to pharmaceutical microbiology, including environmental monitoring and laboratory analysis Akua Gilbert-Arthur, Principal Scientist, Roche Molecular Systems 12.20 Networking Lunch 13.20 Lessons learned in microbial data integrity management • Data integrity within analytical and microbiology laboratories for all phases of the drug product lifecycle • What works well? How can it be improved? • Examining the recently released draft guidance data integrity and compliance with CGMP guidance for industry Lina Orjuela, Microbiologist, Merck 14.00 Microbial data deviation investigations • Common causes of MDD • Microbial identification programs • Collaborating with other departments • When a MDD should be escalated to a DR Jarett Scalzo, QC Microbiology Manager, Kite Pharma Inc. BIOFILMS & OTHER CONTAMINANTS 14.40 Additional background on biofilm, its impacts in healthcare, her discovery, and current testing. • We are losing the war on bacteria. One of the reasons is biofilm -- the sticky substance that bacteria form in order to attach to surfaces and then shield the developing colony from environmental stresses • It is no coincidence that every bacterium on the lists of the Center for Disease Control are biofilm-formers: urgent threats (C. diff, etc.), pandemic threats (pneumonia, T.B., E.coli, Salmonella, Listeria, cholera, plague, etc.), bioterror threats (anthrax, etc.),, and antimicrobial-resistant strains (MRSA, MDR-TB, CRES, etc.) • As biofilm builds it captures other bacteria, and there is evidence of horizontal gene transfer between different species • There are few remedies for biofilm. Scraping and sterilization work, but they are short term. Biofilm was recorded on a titanium plate within 30 seconds after sterilization • The human immune system, biocides and antibiotics are designed to kill free-floating bacteria. Nothing known can remove pre-formed biofilm at non-lethal doses Cynthia Burzell, Founder & CSO, Aequor, Inc. 15.20 Afternoon Tea 15.50 Challenges with contamination issues • Mold - A simple method to eliminate and prevent mold anywhere. • Biofilm - Simple and fast methods to eliminate and prevent biofilm • Spores - Simple ways to eliminate quickly and safe for your equipment/surfaces Brian Hubka, CEO, BGH International, LLC 16.30 Common errors in microbial identification and implications • Phenotypic vs. Genotypic systems-capabilities and deficiencies • Deficient media quality control • Microbiology laboratory training deficiencies that lead to errors • Growth media and incubation errors • Gram staining errors • What to do when in doubt • Case studies Ziva Abraham, CEO, Microrite 17.10 Chairman’s Closing Remarks and Close of Day Two Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 MARKETING OPPORTUNITIES Want to know how you can get involved? Interested in promoting your services to this market? Contact Zoe Gale, SMi Marketing on +44 (0) 207 827 6132 or email: [email protected] Supported byOfficial Media Partners:
- 4. Overview of the workshop: This session will discuss pathways to use the data obtained from environmental monitoring to provide proactive and practical solutions for comprehending and managing everyday pharmaceutical microbiology challenges. This presentation will cover case studies on human flora and spore contamination in cleanroom operations. The workshop will cover the most common causes of contamination: operators, items brought into the cleanroom, and degradation of the cleanroom over time. Case studies in operator borne contamination will be discussed as well as preventative long term solutions. Targeted long term solutions will be discussed regarding the spore case studies in a concerted effort to limit reoccurrences. The overall objective and scope of this seminar will be to discuss specifi c cases studies that have occurred in my years of experience in the industry. The concepts of cleaning and disinfection, application frequency, disinfectant rotation, and rinsing and residue removal strategies will be covered as well. Why should you attend this workshop: This industry workshop will give attendees valuable insight into the world of contamination control and troubleshooting fungal and bacterial spore excursions in cleanrooms. Attendees will gain new insight into common causes of CAPA investigations which will cut down on time that is invested finding potential causes for contamination which can cost an organization 50K per investigation. Programme 08.30 Registration & Coffee 09.00 Opening remarks & introductions 09.15 Introduction • Conventional methods • Limitations 09.45 Sensing fundamentals • Absorption and fluorescence • Vibrational and Raman spectroscopy • Mass spectrometry 10.30 Morning Coffee 11.00 Utilisation of spectrometric methods • Advantages and limitations of new methods • Comparisons to traditional microbial quality control 11.30 Industry case studies • Vegetative organisms • Fungal spores • Bacterial spores 12.15 Interactive exercise 12.30 End of workshop About the Workshop Leaders: Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for sixteen years. His current technical focus is microbial control in cleanrooms and other critical environments. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. He is a member of the PDA’s Environmental Monitoring Group, Contamination Control Group, and Biotech Interest Group. Dr. Andrew P. Bartko received a B.S. from the University of Pittsburgh in 1997 and a Ph.D. in physical chemistry in 2002. Dr. Bartko is a senior scientist in Battelle’s Technology Development Group where he contributes to several applied spectroscopy efforts that focus on biological and chemical sensing. Dr. Bartko is the manager and technical leader of an interdisciplinary team that is developing Battelle’s Resource Effective Bioidentifi cation System (REBS). About the Organisation: STERIS is a global leader in infection prevention, contamination control, surgical and critical care technologies, and more. STERIS is the world’s pre-eminent infection prevention, decontamination, and surgical and critical care company. Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Technologies for Monitoring Contamination Control and Case Studies on Contamination Control Workshop Leaders: Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation and Andrew Bartko, Research Leader, Battelle Memorial Institute HALF-DAY PRE-CONFERENCE WORKSHOP Wednesday 7th June 2017 08.30 – 12.30 Hyatt Regency, Mission Bay, San Diego, CA
- 5. Overview of the workshop: Determining best way to work with Microorganisms to ensure we have sterilization that verifies we have no patient risk or product stability issues due to survival of the microorganism or damage to the product due to sterilization. Why should you attend this workshop: Knowing how to most effectively establish your D-values, Z-values, F-values and Fbio-values along with Fo, FH and lethality based on your bioburdens and any biological indicator you select to use in your process based on the variables associated with so many different issues associated with different products that all need to be proven to be sterile prior to distribution. Programme 13.30 Registration & Coffee 14.00 PNSU – BIOBURDEN – Probability Function D values, Z values and Fo • How were those established? • Where Did “Fo” start relative the microbial impact • Microbiological D value variations • Can’t typically use what the vendor provides for D values and Z values based on your product trying to be sterilized. • Typical BI Death Curve and Fraction Negative • D121 value, Z value and Determination of Fo • Bioburden Monitoring and determination of potential sterilization risk compared to any biological indicator 15.30 Afternoon Tea 16.00 Recent FDA Sterilization Observations Resulting in Warning Letters – Providing what the FDA has written about a variety of different situations that has caused significant concerns based on many companies not having the correct perspective about Microbiological Sterilization. 17.20 Closing remarks 17.30 End of workshop About the Workshop Leader: Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US. He has worked with or assisted more than two dozen companies with the establishment of controlled document/ qualitysystems,FDAbriefingandsubmittaldocuments,project management of several multimillion dollar projects including design, start-up and validation to assure fast track FDA approval by maintaining strict regulatory compliance during all phases of engineering, construction, commissioning and validation, and has written numerous submission documents for product, process and facility approval/licensing which also required the development of quality systems which included customer complaint management, deviation management, CAPA and associated site wide employee training. Each of his projects have been received and accepted by the FDA and other regulatory agencies. Jerry is considered and expert in most all aspects of the biopharmaceutical and medical device industry and has trained many FDA field inspectors on a variety of topics. None of his work has ever received a 483 but has corrected and prevented many along with Warning Letter remediation. About the Organisation: JD Technologies provides consulting, regulatory and documentation support to the pharmaceutical and biopharmaceutical industries. JD Technologies prides itself on being able to succesfully carry a project from concept to completion, and integrating with other company employees and contractors in a team effort. Microbial Required Use for Terminal Sterilization Workshop Leader: Jerry Dalfors, Principal, JD Technologies HALF-DAY PRE-CONFERENCE WORKSHOP Wednesday 7th June 2017 13.30 – 17.30 Hyatt Regency, Mission Bay, San Diego, CA
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