Pharmaceutical Microbiology West Coast 2018
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The document outlines the agenda for the 2nd Annual Pharmaceutical Microbiology West Coast conference on June 7-8, 2018 in San Diego. The conference will focus on key challenges and developments in pharmaceutical microbiology, with sessions on environmental monitoring, rapid methods, data integrity, aseptic processing, regulatory updates, and microbial identification. Speakers will present case studies and discuss issues like microbiological deviations, contamination control, disinfectant efficacy testing, and applying pharmaceutical microbiology technologies to other fields like human diagnostics. Workshops on June 6 will address risk-based environmental monitoring and microbial contamination control technologies.
Pharmaceutical Microbiology West Coast 2018
- 1. HIGHLIGHTS IN 2018: • Examine the underlying issues behind microbiological deviations and the impact on data integrity • Learn about ways to proactively limit bacterial and mold spore contamination from incoming items into cleanrooms, through case study examples • Discuss new thinking about facility cleaning and sanitisation and the effects that this will have on the common and best practices to implement • Explore how technologies in pharmaceutical microbiology could be applied, utilised and translated into other fields @SMIPHARM #pharmamicrousa JUNE 2018 Pharmaceutical Micr biology West Coast WORKSHOPS: 6th CONFERENCE: 7th-8th SMi presents the 2nd Annual Conference on… Crowne Plaza San Diego - Mission Valley, CA, USA Delivering updates and promoting discussion on key challenges and developments within the pharmaceutical microbiology industry www.pharma-microbiology-usa.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 GROUP BOOKINGS ACADEMIC DISCOUNTS AVAILABLE CHAIR FOR 2018: KEY SPEAKERS INCLUDE: • Ziva Abraham, CEO, Microrite • Lisa Yan, Principal Quality Lab Associate, Shire • Dilip Ashtekar, Executive Director Sterility Assurance and Microbiology Quality, President, Intarcia Therapeutics, Sterility Assurance and Microbiology Consultant • Austin Swafford, Director of Research, Center for Microbiome Innovation • Ron Smith, Director External Supply Integration Quality, Janssen • Elia Sanchez, Microbiology Site Head QC Sr Manager, Genentech • Mike Russ, Manager, QC Microbiology, Genentech • Heidi Anderson, Principal Scientist, Abbott WORKSHOP A A practical guide to “Risk Based Environmental Monitoring” that addresses real world risk of contamination control 08:30 – 12:30 Leader: Ziva Abraham, CEO, Microrite Morgan Polen, Contamination Control and Cleanroom Expert, Microrite WORKSHOP B Technologies for Microbial Contamination Control 13:30-16:30 Leader: Andrew Bartko, Research Leader, Battelle Memorial Institute PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS Wednesday, June 6th, 2018, Crowne Plaza San Diego - Mission Valley, CA, USA Sponsored by:
- 2. Pharmaceutical Microbiology West Coast Day One | Thursday, June 7th, 2018 www.pharma-microbiology-usa.com 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 events please call: Alia Malick on +44 (0) 20 7827 6168 or email: [email protected] 8.30 Registration Coffee 9.00 Chair's Opening Address Ziva Abraham, CEO, Microrite ENVIRONMENTAL MONITORING, RAPID METHODS AND ENDOTOXIN TESTING 9.10 The arising issues with environmental monitoring following the implementation of more advanced monitoring equipment • New technology that has been implemented into monitoring techniques • The impact of these new technologies e.g. the improved biocounts that new technology can measure of new microbes • The monitoring issues which arise due to the implementation of these new technologies • Strategic monitoring methods to establish exactly where the contamination is coming from Ron Smith, Director, External Supply Integration Quality, Janssen 9.50 Rapid microbial methods — A case study of implementation • The implementation of rapid methods in practice; how best to adopt these new methods and keep up with developments • Validating the methods and conforming to regulatory requirements • The issues surrounding the implementation of rapid methods and how to overcome them • How to best tailor your implementation proposal in terms of validation of your rapid method Andrew Bartko, Research Leader, Battelle Memorial Institute 10.30 Morning Coffee Networking 11.00 BET testing: strategies for testing difficult samples • A short overview of the Bacterial Endotoxin Test methodology • Potential interactions between the matrix and assay components rendering the samples difficult to test • Strategies by sample type • Presenting a case study Veronika Wills, Technical Services Specialist, Associates of Cape Cod 11.40 Changing a paradigm: developing a roadmap to implementing a real time microbial detection analyzer in pharmaceutical water • Evaluating the potential for comparing Auto Fluorescent Units (AFU) to Colony Forming Units (CFU) • Discuss results of a study that evaluated the 7000RMS in a GMP Water for Injection system • Setting alert and action limits • Detail next steps: evaluation phase to implementation Mike Russ, Manager, QC Microbiology, Genentech 12.20 Networking Lunch DATA INTEGRITY AND ASEPTIC PROCESSING 13.30 Strain Typing: A valuable tool for tracking microbial contamination • Overview of microbial identification methods • Assessment of identification platforms for species to strain-level characterization • Utility of microbial strain typing in the pharmaceutical industry • Tracking strains - Case studies Bindhu Verghese, RD Sr Staff Scientist Microbial Solutions, Charles River Laboratories 14.10 Introduction to a global disinfectant efficacy study approach • Leveraging multi-site data within a company • Selection of representative surfaces and environmental in-house isolates • Developing a global disinfectant efficacy study: Considerations and challenges Lisa Yan, Principal Quality Laboratory Associate, Shire 14.50 Afternoon Tea Networking 15.20 Underlying issues behind microbiological data deviations and data integrity • Microbiological data deviations, investigations and data integrity related FDA observations are on the rise throughout the pharmaceutical arena. Any of these deficiencies can be avoided with a contamination control mind-set from the get go • Microbiological data deviations occur due to many reasons; inadequate facility, barrier design and airflows visualization studies. inadequate process/laboratory controls, lack of understanding of gowning and cleaning are also a factor. Case studies to demonstrate this • Main reasons for deviant EM data and data integrity Ziva Abraham, Founder and CEO, Microrite 16.20 Aseptic processing in manufacturing • The current struggles and issues with upholding aseptic manufacturing processes and practices • Cross-contamination considerations that need to be taken into account during manufacturing processes • Contamination in bioprocessing equipment • Containment strategies that can be used to circumvent these issues – which methods would be the best for you? William Fleming, Chief Consultant, GXP Consultants Inc 16.40 Chair's Closing Remarks and Close of Day One Official Media Partners: Supported by:
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Pharmaceutical Microbiology West Coast www.pharma-microbiology-usa.com Day Two | Friday, June 8th, 2018 8.30 Registration Coffee 9.00 Chair's Opening Address Ziva Abraham, CEO, Microrite REGULATORY UPDATES AND MICROBIAL IDENTIFICATION 9.10 How the technologies in pharmaceutical microbiology could be applied, utilised and translated into other fields • Case studies to show that the human microbiome is affected by large amounts of environmental influences e.g. chemicals released into the environment could end up in the water systems • As such, water microbial detection techniques and environmental monitoring equipment could be used and applied to human biology • How technology used in pharmaceutical microbiology could be developed and applied to human diagnostics e.g. quick diagnostic testing derived from RMM Austin Swafford, Director of Research, Center for Microbiome Innovation 9.50 Combining genetics with traditional methods to increase accuracy in microbial ID • Summary of the Genetic Analysis Technology • Bacterial ID vs Fungi ID • Exceptions to the rules • Traditional methods (back to the basics case studies) Elia Sanchez, QC Microbiology Sr. Manager, Genentech 10.30 Morning Coffee Networking BIOBURDEN TESTING AND CONTAMINATION CONTROL 11.00 Controversies and questions about non-sterile bioburden testing • Bioburden testing and monitoring for the non-sterile manufacturer • Establishing a microbiological testing program that makes sense for your product • How to manage challenges, controversies and questions about non-sterile bioburden testing Heidi Anderson, Principal Scientist, Microbiology, Abbott Laboratories 11.40 Fungal and bacterial spore excursions in cleanrooms — case studies • The industry has seen an increase in the number and species of bacterial endospores and mold spores found in many facilities. This presentation will focus on ways to proactively limit bacterial and mold spore contamination from incoming items into cleanrooms and limit other sources of spore contamination • Current industry regulations in the US and Europe will be discussed related to sporicides and disinfectants. Additionally, the presentation will convey a robust approach to addressing bacterial and fungal spores by covering personnel practices, incoming items into cleanrooms, facility design and conditions, and the products used to address bacterial and mold spores as well as more resistant bacterial spore species such as bacillus cereus • New and recent case studies will be covered which focus on new antimicrobial chemistries and their performance against fungal and bacterial spores in cleanrooms. The attendees will ascertain a better approach to root causes and determining sources of spore contamination in their cleanroom and controlled facilities Jim Polarine, Senior Technical Service Manager, STERIS Corporation 12.20 Networking Lunch 13.30 The background and implementation of mycoplasma testing • The PCR approach of mycoplasma testing vs the growth method – what are the similarities and differences between the two approaches? • The conceptual backing behind mycoplasma testing – what the test is hoping to achieve • Should rapid in-house testing be favoured or contract manufacturing of the test? Meghan May, Associate Professor of Biomedical Sciences, Microbiology and Infectious Disease, University of New England 14.10 How rapid mycoplasma safety testing could revolutionise quality control and lot release in biopharmaceutical manufacturing • Safety issues - why are mycoplasmas of major concern in biopharmaceutical processes • Regulatory overview for mycoplasma testing • Current trend towards automated PCR-based in-process control and lot release mycoplasma testing • Product-specific multi-step mycoplasma PCR validation concepts Renate Rosengarten, Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna 14.50 Afternoon Tea Networking APPLICATIONS OF PHARMACEUTICAL MICROBIOLOGY AND MYCOPLASMA TESTING 15.20 New thinking about facility cleaning and sanitisation • Differences between facility cleaning and sanitization and between in-vitro and in-situ disinfectant qualification • Best practices for facility cleaning and disinfectant qualification and myths about disinfectant qualification • Best practices for preventing contamination due to facility cleaning and sanitization • Data integrity aspects related to facility sanitization program and disinfectant qualification and facility surveillance programs Dilip Ashtekar, Senior Director, Sterility Assurance, Intarcia Therapeutics 16.00 An update on the re-structuring of the FDA inspection structure • The re-organisation of the FDA inspection structure • What impact this would have upon your regulatory inspections – would routine inspections be affected? • Does this re-organisation come with any updated regulatory expectations? • How the re-organisation would affect the biotech industry David Hussong, Former Associate Director for New Drug Microbiology, FDA (Current Position: CTO, Eagle Analytical Services) 16.40 Chair'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 PARTNERSHIP OPPORTUNITIES SMi Group is offering companies the opportunity to partner on our dedicated events in order to help raise your company profile, add value, create awareness of your products/services to our key audience within the pharmaceutical industry. Interested in partnering? Contact Simi Sapal, Marketing Manager on +44(0)207 827 6162 or email: [email protected] We are proud to be partners with:
- 4. HALF-DAY PRE-CONFERENCE WORKSHOP B Wednesday, June 6th, 2018 13:30-16:30 Crowne Plaza San Diego - Mission Valley, CA, USA TECHNOLOGIES FOR MICROBIAL CONTAMINATION CONTROL Workshop Overview: The workshop will begin with a survey of technology uses for contamination monitoring, including spectrometric and optical methods that are used for sensing. Operating principles will be discussed and related to microbial attributes being interrogated. The Pros and Cons of the methods will be discussed with respect to the currently available technology offerings on the commercial market. Finally, the practical aspects of implementation, validation, pitfalls and regulatory considerations will be discussed. Why you should attend: • Synopsis of technologies used in Rapid Microbial Methods options to the industry • Technical description of sensing of contaminants in production • Advantages and limitations of contamination sensing • Barriers to implementation • Comparison to traditional methods Workshop Leader: Dr. Andrew P. Bartko received a B.S. from the University of Pittsburgh in 1997 and a Ph.D. in physical chemistry in 2002. His graduate work consisted of deciphering spatially heterogeneous relaxation dynamics of glass forming systems using novel rotational single molecule microscopy techniques. In 2002, Dr. Bartko joined the Softmatter Nanotechnology and Advanced Spectroscopy Team at Los Alamos National Laboratory where he studied the ultrafast photophysics of semiconducting quantum dots. 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. He now leads Battelle’s Rapid, Enumerated, Bioidentification System development program. Organisation Synopsis: 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. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org Agenda: 13.30 Registration and Coffee 14:00 Opening Remarks and Introductions 14:10 Session 1: Introductions and technology options • An introduction to the current technologies used for microbial contamination control • The current technology options available to the industry • Pros and cons of methods with respect to current availability in the commercial market 14:40 Session 2: Technical aspects of sensing • Spectrometric methods • Optical methods used for sensing • Operating principles and their relation to microbial attributes 15:00 Afternoon Tea 15:30 Session 3: Implementation of strategies • Practical aspects of the implementation of these strategies • Hurdles to overcome during and after implementation • Case studies of implementation 16:00 Session 4: Validation pitfalls to avoid • The best validation methods to use • Pitfalls and issues which need to be circumvented • Regulatory considerations 16:30 End of Workshop HALF-DAY PRE-CONFERENCE WORKSHOP A Wednesday, June 6th, 2018 08:30 – 12:30 Crowne Plaza San Diego - Mission Valley, CA, USA A PRACTICAL GUIDE TO “RISK BASED ENVIRONMENTAL MONITORING” THAT ADDRESSES REAL WORLD RISK OF CONTAMINATION CONTROL Workshop Overview: Learn how to apply the updated ISO Cleanroom Standards and comply with EU Guidance as well as assess product risk through effective cleanroom monitoring. Additionally, learn about choice of monitoring equipment (specification etc.) and establishing risked based sample locations. Why you should attend: All current cleanroom standards and GMP guidance’s recommend or require a risked based monitoring approach. Additionally, there is an increase in regulatory observations related to lack of risk based environmental monitoring. This workshop will address the requirements and provide guidance on how to establish a risk based Environmental Monitoring Program. Multiple Case Studies will be utilized as examples related to deficient Environmental Monitoring Programs which have led to 483 observations, warning letters and data integrity issues. Workshop Leaders: Ziva Abraham is the CEO of Microrite, a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation. Ziva has over 25 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi for her PhD degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/ veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective. Morgan Polen, Contamination Control and Cleanroom Expert of Microrite, has been involved with cleanrooms and contamination control since 1984. He has worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, AFV, monitoring program development, particle counter design and product management for cleanroom related products and systems. He has addressed monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards. Organisation Synopsis: Microrite is a San Jose, CA based Consulting Company helping Pharmaceuticals, Biotechnology, Medical Devices, In-Vitro Diagnostics and Combination products in the areas of Quality Assurance, Contamination Control, Microbiology, Process Development, Process Validation, Facility, Utility and Equipment Validation Agenda: 8:30 Registration and Coffee 9:00 Opening Remarks and Introductions 9:10 Session 1: Case Study Review: Learn from the mistakes of others • Case Study: Poorly designed aseptic filling line and monitoring program leading to media fill and product failures • Case Study: Poorly chosen monitoring equipment and integration • Case Study: Inadequate air flow visualization studies leading to incorrect (not risk-based) monitoring locations 9:50 Session 2: Understanding the changes to cleanroom standards (14644-1,2,3) and current regulatory thinking regarding GMP Annex 1; and discussion on recent 483 observations and warning letters 10:30 Morning Coffee 11:00 Session 3: Key Elements of a Risk Based Monitoring Program • Site selection • Media selection and management • Equipment selection and calibration • Frequency of monitoring • Analyzing EM data to assess risk 11:40 Session 4: Group Exercise • Attendees will select risk based sample sites for a “Virtual Aseptic Filling Line” based upon this course material. Attendees will provide justification for their site selection. 12:30 Closing Remarks and End of Workshop
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- 6. PHARMACEUTICAL MICROBIOLOGY WEST COAST Workshops: Wednesday 6th June 2018, Conference: Thursday 7th Friday 8th June 2018, Crowne Plaza San Diego - Mission Valley, CA, USA 4 WAYS TO REGISTER FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 ONLINE AT www.pharma-microbiology-usa.com POST your booking form to: Events Team, SMi Group Ltd, Ground First Floor, Westminster Bridge Road, London, SE1 7XW If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at [email protected] Unique Reference Number Our Reference LVP-252 DELEGATE DETAILS VAT VAT at 20% is charged on document portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here. DOCUMENTATION I cannot attend but would like to Purchase access to the following Document Portal/ Paper Copy documentation. 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