• Developing a GMP System Scorecard Measuring Your Lab’s Performance
• Systems Approach to GMP Testing in the Analytical Laboratory
• Health Canada HPFB Update on Good Laboratory Practices (GLP) Monitoring
• MHRA Expectations of EU Contract Labs working to GMP
• Dietary Supplements Testing Requirements for GMP Compliance for
• Stability Testing
• Residual Solvents  - Implementing USP Revised General Chapter <467>
• Best Practices for Analytical Method Development 
• Developing and Validating a Robust Dissolution Method
• Common Problems with Dissolution Method Transfer
• HPLC Analytical Method Transfer (AMT): Process and Pitfalls
• The Foundation of a Validated HPLC Method 
• Developing Method Validation Master Plans
• Microbial Control and Monitoring in Laboratory Water Systems
• Outsourcing Strategies for using Contract Laboratories
• Selecting Appropriate Enumeration Parameters for Total Viable Bacteria Determination
• Requirements for Qualification, Calibration, and Maintenance of Laboratory Equipment
• Writing and Executing IQ and OQ Documents Calibration and Maintenance
• New Approaches to Laboratory Automation & Computing
• Going Paperless: Converting from Paper Forms to an Electronic Laboratory Notebook for Routine Analyses
• Design Considerations for FDA governed Laboratories and Facilities

 

Mr. William V. Collentro Senior Consultant Water Consulting Specialists, Inc.

Mr. William V. Collentro has dedicated more than 40 years to water treatment and purification. He obtained both his Bachelors and Masters Degrees in Chemical Engineering from Worcester Polytechnic Institute. He is an adjunct professor at both PDA-TRI and Stevens Institute. He has pub-lished over 100 technical articles including a text on Pharmaceutical Water Systems as well as chapters appearing in other text. He is a member of several technical societies. He was the 1998 recipient of the PDA James P. Agalloco Award for excellence in teaching.

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Dr. Karl Fricke Director , Quality Control Forest Pharmaceuticals

Dr. Karl Fricke is the Director of Quality Control for the Forest Pharmaceuticals manufacturing facility in Cincinnati, OH.  He has over 20 years of experience in cGMP analytical laboratories spanning the development process from pre-clinical to commercial product.  At Forest, his group is responsible for release and stability testing of products manufactured in Cincinnati as well as all aspects of laboratory compliance including equipment qualification, method validation and transfer, computer system validation, Part 11 compliance, and cleaning validation.  Prior to joining Forest, Karl worked for several pharmaceutical companies including Alkermes, Searle, Miles Laboratories, and Parke-Davis.  He has a B. A. in Chemistry from Carleton College, a Ph. D. in Polymer Chemistry from the University of Michigan, and an M. B. A. from the Graduate School of Business at the University of Chicago.

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Ms. Lesley Graham Senior GLP Inspector MHRA

Lesley has been with the agency since July 2002.  In addition to carrying out her duties as a Senior Inspector with the Good Laboratory Practice Monitoring Authority, she was also responsible for setting up a programme of routine inspection of stand alone contract laboratories who perform work to GMP under the 1968 Medicines Act. 

Lesley gained all her qualifications whilst working full time and studying part-time, i.e. HNC in Chemistry, then a BSc in Chemistry. She started her career as a Quality Control Technician with Boots Contract Manufacturing, she then moved onto work as a Research Technician within the Chemistry Department at Strathclyde University.  After graduating in 1994 Lesley moved to Syntex Pharmaceutical Company, Edinburgh.  In 1995 Syntex was acquired by Quintiles.

As an analyst within the Quality Control laboratory her work involved quality control release testing of raw materials and finished products.  In 1997, still with Quintiles she moved into the Manufacturing group as a Supervisor of medicinal products.  Her responsibilities included manufacturing of simple solutions and suspensions used in preclinical studies, to the more complex formulated products such as tablets, capsules and solutions used in early phase clinical trials through to scale up and production of large phase 3 trials, she was also involved in the manufacture of marketed products.  It was during her time at Quintiles she gained experienced of working to both GLP and GMP. 

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Ms. Vivian A. Gray V. A. Gray Consulting, Inc.

Mrs. Gray has spent the last 30 years involved in all aspects of dissolution testing and evaluating new dissolution technology. At the United States Pharmacopeia (USP), she enjoyed a long career serving first as a bench chemist, supervisor and lastly as a liaison to various expert USP committees, including the Biopharmaceutics and Dissolution Expert Committee.  In 1997, Mrs. Gray joined the DuPont Pharmaceuticals Company Analytical Research and Development Section as the Head of the Dissolution Group. In that position, she gained experience in developing discriminating dissolution methods, writing SOP’s and a variety of documents, adhering to strict cGMP practices, and filing CMC aspects of dissolution methods and specifications with regulatory agencies.

Mrs. Gray has been an invited speaker for conferences on 29 occasions, lecturing especially in the areas of calibration, dissolution equipment, sources of error in dissolution testing, method development and validation, new technology, and regulatory topics. She is a proactive participant in the field as demonstrated by 39 publications, writing and revising USP Chapters, initiating change in USP methods, organizing workshops, serving on the USP Biopharmaceutics Expert Committee, the FIP Dissolution Working Group, and the Editorial Board for Dissolution Technologies. She served on the PhRMA Dissolution Committee from 1997 to 2001.  Mrs. Gray received the American Society of Hospital Pharmacists Research and Education Foundation 1982 Research Award for co-authoring an article on packaging using USP calibrator model tablets and received the FDA Commissioner’s Special Citation for involvement in the FDA task force on Gelatin Crosslinking.  Mrs. Gray has co-authored a book on dissolution testing called “Handbook of Dissolution Testing”, Third Edition, published in 2005.

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Mr. Raj Jaisinghani, PE President & CEO Technovation System inc.

Raj Jaisinghani has over 35 years of cleanroom design build experience and R&D experience related to contamination control, aerosol and particle science, fluid mechanics and colloid chemistry. He has 14 patents and is widely published including having authored 2 chapters for McGraw Hill handbooks. He is a registered PE and has degrees in chemical engineering from the Indian Institute of Technology, BHU and has a MS degree and further advanced graduate work in energy conversion from the University of Wisconsin.

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Dr. Philip J. Koerner Senior Technical Manager Phenomenex, Inc.

Bio to be posted shortly

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Mr. Rick Lake Manager, Pharmaceutical Market Development Restek Corporation

Richard Lake is the Pharmaceutical Market Development Manager responsible for overseeing the development and application of chromatographic products for use in the pharmaceutical industry. Prior to this, he worked as a Pharmaceutical Innovations Chemist performing both GC and HPLC pharmaceutical applications, developing and presenting technical material and assisting in new product development. Before joining Restek in 2005, he worked as a study director and principal investigator for a contract research laboratory conducting various pharmaceutical studies, primarily involved in GC and LC method development and validation. During this time, he also managed the stability testing department. Prior to his career in pharmaceutical analysis, he worked as an analytical specialist working on pesticide residue and volatile/semivolatile environmental analyses.

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Mr. Mark Lookabaugh Principal Consultant PAREXEL Consulting

Senior Consultant, provides GMP and QSR auditing and consulting services to PAREXEL clients worldwide.

Prior to joining PAREXEL, he served 30 years with the FDA. His career included work as an Analytical Chemist in the New England District laboratory, specializing in pharmaceutical chemistry. He performed Pre-Approval Inspections (PAIs) in the pharmaceutical and biotechnology industries in the US and overseas. He also served for 8 years as a Compliance Officer in the New England District Office, processing FDA enforcement actions in the 6 New England States. During this period, he managed several medical device cases and gained knowledge of the QSR and MDR regulations. In 2004, he was promoted to Director, Compliance Branch, with responsibility for oversight of all FDA enforcement activities in the New England District. He has published scientific papers in the Journal of Chromatography, and is the recipient of several FDA awards.

Mark received a BS degree with high honors from Worcester Polytechnic Institute, Worcester Massachusetts

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Mr. Joseph G. Liscouski Institute for Laboratory Automation

Joe Liscouski is an experienced laboratory automation professional with over thirty years experience in the field including the design and development of automation systems, LIMS, robotics and data interchange standards. He has held symposia on validation, and presented technical material and short courses on laboratory automation and computing in the US, Europe, and Japan, and wrote an editorial defining the need for Laboratory Automation Engineering as a means of advancing the state-of-the-art. Publications include books and book chapters on computing and automation and over thirty technical papers. His most recent work has centered on the development of a new approach to technology planning and management for automation and computing.

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Ms. Linda McKerral, M.Sc. Research Biochemist, Bioprocess and Bioanalytical Research Merck Research Laboratories

Ms. McKerral joined the Bio-Process Research and Development analytical department of Merck & Co., Inc. (West Point, PA) in 2001.   As Research Biochemist, she develops and executes analytical testing strategies to characterize GMP master and working cell banks and production cultures.  Cell bank and culture characterizations include tests for (culture) purity, identity (to species and strain), viability, and genetic stability; data are used to support regulatory filings for vaccines and biologicals.  She holds a Master of Science degree in Microbiology from the University of Guelph and a Bachelor of Science degree in Biology from the University of Waterloo.

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Ms. Carmen Medina Founder, President Precision Consultants Inc.

Carmen Medina oversees PCI’s consulting services for the West Coast BIO region and internationally from her San Diego office. She was a former Commissioned Officer in the United States Public Health Service and an FDA investigator, where she led an international group within Team Biologics and helped usher in the new medical device regulations—QSR. Ms. Medina, a graduate of the Columbia University School of Administrative Medicine and School of Public Health, is internationally renowned for her work with the biotech, pharmaceutical and medical device industries. Over the past 20 years, she has assisted with the development, successful approval, and commercialization of hundreds of products, including some of the largest pharmaceutical and biotech brands.  She has also consulted with several vaccine manufacturing companies throughout the world, including The Salk Institute Biotechnology/Industrial Associates. Ms. Medina has helped numerous pharmaceutical, medical device and biologics firms with FDA inspection-readiness and specializes in risk management, compliance, quality assurance and regulatory strategy. Her unique approach to PAI-readiness has garnered PCI extensive accolades from both domestic and international companies for its support in the commercialization of medically needed products. She is editor of the textbook, The Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics, as well as numerous articles related to reimbursement, innovative approval pathways, and exit strategies for start-up and emerging biotech companies.

Ms. Medina teaches Quality Assurance for Biotechnology at the UCSD Extension Program and offers a series of highly valued industry-specific courses.

For more information, please visit PCI’s website for additional information about it’s specialty services. www.precisionconsultants.com

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Mr. Jason Rancourt Science Coordinator and Policy Advisor, Health Products and Food Branch Health Canada

Jason M. Rancourt is currently a scientific coordinator and policy advisor working in the Office of Science and Risk Management within the Health Products and Food Branch of Health Canada (HPFB).

After receiving a degree in biochemistry from the University of Waterloo, Mr. Rancourt immediately began full-time work in the study of the human health effects of biopesticides. Following this, he was transferred into the Canadian Science Centre for Human and Animal Health in Winnipeg within the Host Genetics and Prion Division of the Public Health Agency of Canada, specializing in bioinformatics and single-nucleotide polymorphism detection and characterization. Mr. Rancourt then moved to the Product Safety Bureau of the Healthy Environments and Consumer Safety Branch of Health Canada as a regulatory project officer where he has authored several amendments to the Hazardous Products Act, and was involved in the regulation of nanotechnology in consumer products. Last spring he was promoted into the Assistant Deputy Minister’s Office of HPFB, where he has helped guide the implementation of Health Canada GLP data requirements for non-clinical safety testing of biologics and pharmaceuticals.

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Ms. Wendy Saffell-Clemmer Sr. Manager Pharmaceutical Development Baxter Biopharma Solutions

Ms. WendySaffell-Clemmer, is recognized as an expert in the field of analytical methods ofparenteralproducts and is a frequent presenter at the annual IBC Bioprocess International and AAPS Biotech conferences. Ms.Saffell-Clemmerauthored and contributed to key publications on analytical methods includingBioPharmInternational and Pharmaceutical Technology. She earned her M.S. in Physical Chemistry from Northwestern University and her B.S. in Chemistry from the University of Virginia. Ms.Saffell-Clemmercurrently manages a group of 13 scientists responsible for the development, validation and transfer of all chemical analytical methods in Bloomington. Prior to joining Baxter, she held a number of positions with Eli Lilly & Company.

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Dale Seabrooke VP of Sales and Marketing Labtronics Inc.

Dale Seabrooke VP of Sales and Marketing Labtronics Inc. has over 14 years of experience in the field of Laboratory Informatics. Throughout this time his focus has been on providing solutions that automate the management of data and information in the laboratory.

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Dr. Erika Stippler Director of Dosage Form Performance Laboratory U.S. PHARMACOPEIA

Erika Stippler, Ph.D., has more than sixteen years experience in the pharmaceutical industry and has worked at various Contract Research Organizations in Germany and Switzerland. Currently, she is the director of the Dosage Form Performance Laboratory at the U.S. Pharmacopeia in Rockville, MD.

Dr. Stippler studied chemistry in Romania and received her M.S. in chemical engineering in 1989 at the Babes-Bolyai University Cluj-Napoca.

Beginning in 1992, she worked as an analyst in Zentrallaboratorium Deutscher Apotheker, Eschborn and starting in 1996 as an external Ph.D. student at the W. J. Goethe University Frankfurt Institute of Pharmaceutical Technology. Under the guidance of Prof. Dr. Jennifer B. Dressman, she received her Ph.D. in 2004. The title of her thesis is “Biorelevant Dissolution Test Methods to Asses Bioequivalence of Drug Products”. From 1998 to 2002, she was the head of the Department Biopharmacy/Stability Testing of Laboratory and Quality Services in Eschborn, Germany. Following, she took over the position of technical director of PHAST laboratories. After 9 months project management at Solvias, Switzerland she accepted the director position at the U.S. Pharmacopeia.

Her scientific interest is focused on IVIVC-based dissolution method development for various dosage forms and on the characterization and standardization of dissolution apparati and dissolution methods for performance evaluation of pharmaceutical products.

She is a member of American Association of Pharmaceutical Scientists (AAPS) and International Association for Pharmaceutical Technology (APV).

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Mr. Darryl Sullivan Senior Manager of Technical Services for Analytical Chemistry Covance Laboratories

Darryl Sullivan the Senior Manager of Technical Services for Analytical Chemistry at Covance Laboratories. Mr. Sullivan acts as the primary liaison with food, nutritional and dietary supplement clients as well as providing expertise on designing comprehensive testing programs to meet scientific and regulatory requirements.   He has managed a number of different departments in the food and drug analysis areas including lab operations, research and development, client services, sample management, sample preparation and study direction. In addition, he has managed an off-site satellite laboratory in Michigan.Darryl received his BS from the University of Wisconsin-Madison and has more than 25 years of experience in laboratory testing of food and dietary supplements. He is considered an expert the field of validation of analytical methods and served for three years as Chair of the AOAC INTERNATIONAL Official Methods Board. He is currently the Secretary of the AOAC INTERNATIONAL Board of Directors and is a past member of the Board of Directors of the AOAC Research Institute. Mr. Sullivan has developed and validated hundreds of analytical methods in the areas of nutrient and residue testing and is the author of more than 25 publications and over 100 scientific presentations. In addition, he is the current Chair of the AOAC Dietary Supplement Task Group and co-editor of the book Methods of Analysis for Nutrition Labelling

 

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Dr. Michael Swartz Research Director, Analytical Chemistry Services Synomics Pharma Services

Michael E. Swartz, Ph. D. recently joined Synomics Pharmaceutical Services in Wareham MA as Research Director, after having been at Waters Corporation as a Principal Consulting Scientist (and other roles) since 1985. In his new position, he is responsible for Analytical Chemistry Services, and new business and market development. Dr. Swartz received his bachelor's degree in Chemistry from the State University of New York College at Cortland and Master's degrees in Chemistry and Forensic Chemistry from Northeastern University, and he earned his Ph.D. degree in Chemistry from the University of Rhode Island. He is the author/editor of books on validation, combinatorial chemistry and capillary electrochromatography, several book chapters on various subjects, over 60 manuscripts, four patents, and has presented over 175 contributed and invited papers at various technical symposia and conferences around the world. Dr. Swartz’s interests include general liquid chromatography and mass spectrometry theory, with an emphasis on development, increased sensitivity, and validation of high sample throughput and automated methods for the both the research and regulated pharmaceutical industry. He has served on the Scientific Editorial Advisory Board of LC/GC Magazine since 1998, where he co-authors the popular Validation Viewpoint column.

Professional memberships include: American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), MASSEP, the Institute of Validation Technology (IVT), and Sigma Xi. Dr. Swartz has consulted, taught courses and lectured on method development and validation and other topics worldwide for over 25 years.

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Day 1 - HALF DAY WORKSHOPS - Wednesday May 6, 2009
TRACK A 8:00 AM - 8:30 AM - Registration and Continental Breakfast 8:30 AM - 12:00 PM (Coffee Break -10:15 AM - 10:30 AM) - Workshop A1 - "A Systems Approach to GMP Testing in the Analytical Laboratory" I.  The Regulatory Background of GMP Testing Features Unique to the GMP Laboratory GMP Requirements Other Guidance Documents The Analytical Development Laboratory:  Good Science vs. Good Compliance II.  Quality Systems in the Laboratory Defining the 20 Laboratory Quality Systems The 6 Quality Process Systems In-Depth The 10 Laboratory Process Systems In-Depth The 4 Laboratory Facilities & Equipment Systems In-Depth III.  Measuring Your Performance Developing and Applying a Risk Assessment Model Developing and Applying a GMP System Scorecard Defining and Applying Suitable Metrics 12:00 PM - 1:30 PM - Lunch & Exhibition 1:30 PM - 4:45 PM (Coffee Break -3:00 PM - 3:15 PM ) - Workshop A2: "A Roadmap to Laboratory Compliance: cGMPs to Inspection Readiness" FDA’s Latest Thinking and Expectations ICH and FDA Guidelines and Initiatives Principles of Methods Validation Master Plan Integrating Risk Management into Stability Testing Program Recall Prevention as an intrinsic component of Laboratory Quality Management Laboratory Inspection Readiness: Soup to Nuts Interactive Exercise—fun, fun, fun!   4:45 PM - 5:00 PM - Question & Answer	TRACK B 8:00 AM - 8:30 AM - Continental Breakfast 8:30 AM - 12:00 PM (Coffee Break -10:15 AM - 10:30 AM) - Workshop B1 - Dissolution Workshop: Developing and Validating a Robust Dissolution Method, including Sources of Problems in Dissolution Method Transfer. Developing and Validating a Robust Dissolution Method, including Sources of Problems in Dissolution Method Transfer. This session will cover an in depth discussion of method validation parameters and criteria for acceptability. A practical In-Vessel validation scheme will be presented. The emphasis will also be on developing a robust method incorporating the principles of Quality by Design. A discussion of Design of Experiments will be included. The sources of problems in method transfer and intermediate precision will be explored.  Develop understanding of basics for a good dissolution method Resources for method validation parameters Utility of robustness validation Looking at intermediate precision as early read for method transfer An example of an in-vessel full validation scheme Identify sources of error Understand most problems with dissolution method transfer 12:00 PM - 1:30 PM - Lunch & Exhibition 1:30 PM - 4:45 PM (Coffee Break - 3:00 PM - 3:15 PM) - Workshop B2: HPLC Workshop Part One - Robustness Studies: The Foundation of a Validated HPLC Method Robustness testing is the cornerstone of any good method validation process, and investing in a thorough and properly designed robustness study can pay great dividends down the road. This presentation will define robustness, introduce a few approaches to designing a robustness study, and discuss data analysis necessary to help insure successful method implementation and transfer as part of a method validation protocol. 1. The Role of Robustness in HPLC Method Validation Examine when to perform robustness studies Learn why robustness is an important part of HPLC method validation Understand where robustness studies fit relative to other method validation performance characteristics in a validation protocol Learn how to plan for robustness during method development 2. Robustness Terms and Definitions Understand how robustness is defined Learn how robustness is measured and documented Gain insight into how robustness affects other method validation performance characteristics in a validation protocol Learn about the role robustness plays in determining system suitability 3. Determining HPLC Robustness Factors Learn how to identify the pertinent robustness factors Understand how to determine the factor ranges Gain insight into which chromatographic parameters to monitor during robustness evaluation Examine the differences between isocratic and gradient HPLC method Robustness 4. HPLC Method Robustness Study Experimental Design Learn about the difference between univariate and multivariate experimental approaches Determine how to choose a screening design that works best for your application Examine different experimental design examples. 5. Analyzing and Documenting the Results Learn how statistics are applied to evaluate HPLC method robustness Understand how software can play a role in robustness studies Gain insight into how to document the results in the final report; graphs, figures, tables, limits, and precautionary statements Multiple examples and cases studies will be examined throughout the presentation. Part Two - HPLC Analytical Method Transfer (AMT): Process and Pitfalls The objective of a formal method transfer is to ensure that the receiving laboratory is well trained, qualified to run the method in question, and gets the same results within experimental error as the initiating laboratory. The development and validation of robust methods and strict adherence to well documented standard operating procedures is the best way to ensure the ultimate success of the method. This presentation will examine the analytical method transfer process, including protocol, documentation, and some possible chromatographic pitfalls to avoid. 1. The AMT Process Understand the components of the AMT process. Learn what activities need to take place before initiating AMT Learn about the resources available to plan for the AMT process Gain valuable insight into why a formal AMT process may or may not be necessary 2. The Foundations and Responsibilities for AMT Understand how the responsibilities differ between the originating and receiving laboratories Learn how to ensure a successful AMT 3. AMT Options Learn about the different options available for AMT Understand how to choose which option will work best for you Examine the role HPLC method validation plays in AMT Learn about the essential elements of AMT 4. The Essential Elements of AMT Learn what should go into a the test plan or protocol Understand how the acceptance criteria changes according to the type of method transferred 5. Analyzing and Documenting the Results Examine what goes into an AMT report Learn how statistics are applied to evaluate AMT Understand how to handle out of specification results Learn how to avoid some common AMT HPLC pitfalls Multiple examples and cases studies will be examined throughout the presentation. 4:45 PM - 5:00 PM - Question & Answer
Day 2- PARALLEL SEMINARS - Thursday May 7, 2009
TRACK A: REGULATORY	TRACK B: LABORATORY
8:00 AM - 8:30 AM - Continental Breakfast 8:30 AM - 9:30 AM Talk A1 - Equipment in the GMP Laboratory: Qualification, Calibration, and Maintenance I. Equipment in the GMP Laboratory GMP Requirements Other Guidance Documents The Analytical Development Laboratory: Good Science vs. Good Compliance II. Equipment Qualification Defining the Terms Developing an Inventory Deciding What to Qualify: An Application of Risk Assessment Defining System Requirements (Including Part 11 Compliance) Writing and Executing IQ and OQ Documents III. Calibration and Maintenance Defining the Terms Determining the Intervals:  Time-Based, Activity-Based, or Performance-Based? Developing the SOPs 9:30 AM - 10:30 AM Talk A2 - Practical Approach to the Implementation of Revised General Chapter <467> Residual Solvents Why this change has come about Implications to a lab   Walking through the method Requirements, Calculations, and the Analytical procedure Risk based strategies to eliminate the need to do a lot of testin 10:30 AM - 11:00 AM - Morning Break 11:00 AM - 12:00 AM TBA Information to be posted shortly 12:00 PM - 1:30 PM - Lunch & Exhibitions 1:30 PM - 3:00 PM Talk A4 - End User Role in Design/Build of FDA Governed Laboratories and Facilities Outline to be posted shortly.   3:00 PM - 3:30 PM - Afternoon Break 3:30 PM - 4:15 PM Talk A5 - USP Update: Performance Verification Test of Dissolution Test Equipment In order to assure that a potential high variability in the dissolution results is not due to malfunction of the dissolution tester used, the dissolution equipment has to be properly qualified. The USP Prednisone Tablets RS are suitable for the performance verification of apparatus1(basket) and 2 (paddle) dissolution equipments. Experiments performed in the USP laboratory show that the Prednisone Tablets RS are sensitive to some of the dissolution equipment variables. Thus the results support the suitability of the Prednisone Tablets RS for performance verification test of apparatus 1 and apparatus 2 dissolution equipment. What are the dissolution equipment parameters which may contribute to the high variability in dissolution results? How USP Prednisone Tablets RS indicate a not well controlled dissolution equipment? What are the USP standards for performance verification test? 4:15 PM - 5:00 PM Talk A6 - Case Study: Assessing reliability of commercially available DNA sequencing for microbial species identification DNA sequencing, typically of the conserved ribosomal RNA genes, has become a widely used tool in the identification of bacteria and fungi. However, all commercial laboratories that perform DNA sequencing for microbial identifications do not necessarily use the same procedures or platforms. Following-up on subtle hints of sequence quality variability for a yeast and a bacterial species at one vendor, we sequenced sets of the same or closely-related isolates at additional vendors. We show by DNA sequence alignments that one vendor's DNA sequence-based identifications of microbes lack sufficient specificity and reproducibility for reliable identifications. Our intent is to share some best practices for assuring quality microbial identifications.	8:00 AM - 8:30 AM - Continental Breakfast 8:30 AM - 9:30 AM Talk B1 - A Critical Evaluation of Microbial Control and Monitoring in Laboratory Water Systems – Case Histories Selecting the appropriate enumeration parameters for Total Viable Bacteria determination USP versus EP methodology for compendial laboratory waters The influence of sample point preparation with isopropyl alcohol on Total Viable Bacteria results Chloramines in raw water supplies system design and maintenance requirements to avoid suppression of Total Viable Bacteria results The production of the hydroxyl radical by Total Organic Carbon destruct inline ultraviolet units and its effect on Total Viable Bacteria results as well as laboratory operations 9:30 AM - 10:30 AM Talk B2 - Going Paperless: Converting from Paper Forms to an Electronic Laboratory Notebook for Routine Analyses As laboratories start to consider replacing their paper-based processes with an Electronic Laboratory Notebook they are often surprised at how many paper forms their organization actually uses. In many cases they discover that there are dozens of forms with multiple pages and multiple variations that are widely distributed throughout the enterprise. Converting every single variation of every paper form to an electronic document can appear to be a daunting task. Understanding the available technology as well as how to best manage the ELN deployment, given their needs and their available resources, will help laboratories to maximize the benefits they will receive with the new system in place. Our presentation will help organizations manage their process of moving away from paper by providing guidelines and insight into both the latest technology and the planning process for a successful ELN implementation: Identifying who should be on the project team Identifying the levels of automation that can be incorporated into ELN forms Determining which processes should be a priority for conversion Selecting an implementation process that meets the goals of the project Identifying points of integration between the ELN and existing systems Organizations will learn how to turn the conversion process into an opportunity to assess the forms that they are using and optimize the integration of the ELN with other informatics applications. With this information they will be better prepared to develop and execute a plan that ensures successful (on time, within budget) implementation of an ELN that delivers maximum benefit with minimal impact on the workplace during the transition process. 10:30 AM - 11:00 AM - Morning Break 11:00 AM - 12:00 PM Talk B3 - Mapping a Stability or Environmental Chamber Outlining and Establishing Mapping Procedures Documentation and Equipment Requirements Strategies for identifying data logger locations Monitoring data logger performance Data Management and Storage   12:00 PM - 1:30 PM - Lunch & Exhibitions 1:30 PM - 3:00 PM Talk B4 - A New Approach to Laboratory Automation; Computing Laboratory automation has often been viewed as the development of sophisticated experiments. This presentation will discuss a new methodology that improves the effectiveness of these systems, their ability to meet regulatory requirements and their return on investment. Why a new methodology is needed Managements role in laboratory automation and computing The structure of an effective program Data - information flow model for analytical laboratories Using the model to improve lab operations, integration & regulatory complianc 3:00 PM - 3:30 PM - Afternoon Break 3:30 PM - 4:15 PMTalk B5 - General Water System Design and Purified Water Criteria for Laboratory System Feed water impurities Non compendial product water specifications • Compendial product water specifications Water purification unit operations Storage and distribution systems Chemical and microbial monitoring Point-of-use delivery considerations System maintenance 4:15 PM - 5:00 PMTalk B6 - Using Selectivity to Optimize UHPLC Separations HPLC Separation Theory The Fundamentals of UHPLC The Significance of Column Geometry Understanding the Modes and Mechanisms of Liquid Separations The Chromatographic Properties of Common Bonded Phases Choosing the Proper Stationary Phase
Day 3- GENERAL CONFERENCE - Friday May 8, 2009
8:00 AM - 8:30 AM - Continental Breakfast 8:30 AM - 9:15 AMHealth Canada Update on Good Laboratory Practice Good Laboratory Practices (GLP) is a quality system which applies to all non-clinical testing of substances for the purpose of establishing safety with respect to human health and/or the environment. Although the GLP quality system is encouraged throughout Canadian regulatory programs for health products and food in a variety of guidance documents and policies, there is a legal requirement on Canada as an OECD member country for a formal requirement for GLP compliance in submitted data, and the recognition (or establishment) of some form of GLP monitoring authority for Canadian test facilities contracted to pharmaceutical and biological drug sectors. Canadian companies which are active as suppliers in this area have indicated their desire to see that Canada adopt a stronger system for compliance monitoring for health products and food additives. Several of Canada’s major trading partners have highlighted their concerns that Canada has not yet recognized a national monitoring authority for GLP compliance for health products and food additives. A system is now being established in the Health Products and Foods Branch of Health Canada to demand monitored GLP and add greater assurance to existing pre-market review processes, and also help industry avoid costly failures in test reliability.   9:15 AM - 10:00 AMGMP in Pharmaceutical Laboratories and Working with Contract Laboratories - from the Perspective of an MHRA Inspector This presentation illustrates the legal requirement for good quality control laboratory practice that is both sensible and appropriate in order that the data produced by laboratories is true and accurate and this data can be relied upon to support good quality medicines being put on the market place. Background to the Inspection of contract labs in the UK Expectations of contract labs working to GMP Requirements Misconceptions GLP vs GMP? Common deficiencies   10:00 AM - 10:15 AM - Morning Break 10:15 AM - 11:15 AMRegulatory Inspection Trends of Laboratories Abstract to be posted shortly   11:15 AM - 12:00 PMLaboratory Requirements for QC and GMP Compliance for Dietary Supplements Lab control systems Analytical methods Outsourcing and Quality Agreements for NHPs 12:00 PM - 1:00 PM - Lunch 1:00 PM - 2:30 PMPower Up Your Analytical Method Transfer Analytical method transfers, whether internal or inter-company, are an essential and sometimes troublesome part of the technical transfer process. A robust method transfer process has less risk of deviations or failures, and ultimately less risk of manufacturing delays.  Our analytical development group supports a busy CMO and receives test methods for large and small molecule drugs in every state of development. Real practices and case studies will be presented to illustrate how to plan for a method transfer, expectations of method transfers and potential pitfalls. Developing Analytical Methods for a Protein Therapeutic While small molecule drugs may require only one chromatographic release method for purity and potency, the specific molecular properties of protein therapeutics require multiple methods incorporating a variety of techniques. A case study of the development of an analytical package for an early phase protein product will be presented.  Methods developed included: The key Lab Control areas that end up being cited by FDA A review of FDA Warning Letters in which specific laboratory system problems were cited Successfully responding to issues that are cited on either a Form FDA 483 or in a Warning Letter Questions and Answers 2:30 PM - Conclusion of Program

This three day event with workshops, conference, and exhibition is directed towards Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biopharmaceutical, Biotechnology, Vitamin, Herbal, and allied Life Sciences industries with responsibilities involving the following areas:

• GMP/GLP Compliance
• Quality Control
• Analytical Research & Development
• Microbiology
• LIMS
• Instrumentation and Calibration
• Validation
• Engineering
• Quality Assurance
• Regulatory Affairs
• Suppliers
• Training
• Documentation and Technical Writing
• Contract Laboratories
• Contract manufacturing
• Corporate Officers
• Consultants
• Equipment Sales
  

*information to be posted shortly*

*information to be posted shortly*

Ontario Science Centre
770 Don Mills Road
Toronto ON  M3C 1T3

www.ontariosciencecentre.ca