• Regulatory Basis of Microbiological Testing
  • Microbiology Investigations and USP Perspectives
  • Harmonized Reference Tests
    • Differences between previous <61> and harmonized <61>
    • Differences between previous <61> and harmonized <62>
    • Differences between previous <1111> and harmonized <1111>
    • Recent changes to harmonized <61>, <62> and <1111>
  • Microbial Identification (NEW USP <1113>)
  • Microbiological Best Lab Practices (USP <1117>) (NEW DRAFT)
• Objectionable organisms in pharmaceuticals
• Microbial Growth
  • How it occurs
  • What is required for growth?
  • Growth kinetics – laboratory culture versus nature
  • Effect of stress factors on growth
• The Characteristics of Microorganisms
  • Fungi
  • Bacteria
  • Mycoplasma
  • Viruses
  • Cellular organisation, function
  • Products: toxins, endotoxins, antibiotics, enzymes
• Microbial Identification Techniques
  • What is the significance of a name?
  • Distribution of microorganisms in nature, raw materials and water
  • Distribution of microorganisms in pharmaceutical facilities
  • How to develop robust microbial identification program
• Detection Methods and Their Limitations
  • What can be detected by:
    • The sterility test
    • The bioburden test in its various forms: membrane filtration, pour plate, spread plate, MPN
    • The test for specified organisms
    • The endotoxin test
  • Limits of detection and factors effecting limits of detection
• Validation of Microbial Test Methods
  • Microbiological Limit Tests and Total Counts
  • Basic principles of validating a microbial test system
  • Changes in the New Harmonized Microbial Limits Tests
  • What approaches can you take when a microbial assay test cannot be validated?
• Sterility Test Validation and Critical Parameters
  • Autoclave Monitoring Tests
  • Validation of Steam Sterilization
• Efficacy of antimicrobial preservation
• Rapid Microbiology Identification System
• Validation of Microbiological Rapid Methods (RMM)
• Development of an Effective Disinfectant Efficacy Evaluation Program
• Building a Business Case for a Rapid Micro Method
  

• Validation of Microbial Test Methods
• Sterility Test Validation and Critical Parameters
• Sterilization and Sterility Assurance

Dr. Edward S. Balkovic Principal Scientist – Quality Control Technical Services Genzyme Corporation

Dr. Balkovic is a Principal Scientist in Quality Control Technical Services at Genzyme Corporation, Framingham, MA. He established the lab that is responsible for the identification of all microbial isolates obtained from Genzyme's QC Microbiology testing labs. He conducts special projects and training in the area of Pharmaceutical Microbiology, including numerous studies evaluating new and improved methods for microbial detection and identification.

He received his doctorate in Microbiology and Immunology from Baylor College of Medicine, Houston, TX. Prior to joining Genzyme, Dr. Balkovic has held various positions in Quality Control, Quality Assurance, Regulatory Affairs and Research & Development at both emerging biotechnology and established biologics companies. He has extensive experience as a Clinical Virologist and Microbiologist. Previously, he supervised the National Virology Reference Lab serving all of the U.S. Veterans Administration’s Medical Centers.

Dr. Balkovic is also an Adjunct Associate Professor in the Department of Cell & Molecular Biology at the University of Rhode Island. He teaches in the areas of Clinical Microbiology & Virology, Vaccine Development, Emerging Infectious Diseases, Biowarfare & Bioterrorism, and Biotechnology Product Development & Evaluation.

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Dr. Scott V.W. Sutton President The Microbiology Network

Dr. Scott Sutton earned his B.S. in Genetics from the University of California at Davis, and his Masters and Ph.D. in Microbiology from the University of Rochester (Rochester, NY). After an NIH postdoctoral fellowship at the Medical College of Virginia (Richmond, VA), he went to work for Bausch and Lomb (Rochester, NY) until 1994 when he accepted a position at Alcon Laboratories (Fort Worth, TX). Dr. Sutton left Alcon Laboratories in 2004 as a Director in the R&D division to accept a position as Pharma Consultant (Microbiology) with Vectech Pharmaceutical Consultants, Inc which he left in 2009 as Sr. Director, Microbiology Services.

Scott Sutton is the Principal of Microbiology Network, Inc a company he started in 1995. He is a recognized consultant and trainer with emphasis in GMP, investigations, Environmental Monitoring and contamination control (both Aseptic manufacturing and non-sterile production facilities) and microbiology laboratory audits and operations. The Microbiology Network supplies consulting, training, webinars and Email discussion groups (PMFList, PSDGList and C-CEList)

Dr. Sutton is an active author and speaker for the industry and has served with the USP Analytical Microbiology Committee of Experts since 1993. He is also the current President of the Pharmaceutical Microbiology Forum, a not-for-profit user’s group with a monthly newsletter and an extremely active Email discussion group.

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Dr. William H. Fleming Senior Director, Corporate Microbiology MedImmune, Inc

William H. Fleming, III is a microbiologist/protein chemist with over thirty five years of experience in the healthcare industry in the areas of Quality Control, Quality assurance, Validation, Analytical Method Development and Validation, Analytical Instrument Development, and Process Development. He has extensive experience in pharmaceuticals, medical devices and clinical laboratory sciences. Pharmaceutical experience in aseptic processing, anti-neoplastic drug products, terminal sterilization of ampoules and vials, establishment of environmental monitoring programs for both sterile and non sterile drug products, OOS/CAPA investigations, cGMP  and technical training, equipment and process validations including isolators, analytical instruments, ovens, depyrogenation tunnels, lyophilizers, etc. His Medical device experience includes contract sterilization, contract laboratory services, packaging, biological indicators, medical device manufacturing, environmental control and microbiologically related quality control, coordination of regulatory submissions and the  coordination of regulatory inspections.  Currently, employed by MedImmune, Inc. in the position of Senior Director for Corporate Microbiology. Over twenty years experience in clinical Microbiology directing Clinical Microbiology, Immunology and flow Cytometry Laboratories. Serving as a member of the PDA Task Force that is re-writing Technical Report 33 that deals with Rapid Methods in Microbiology.

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Dr. David Porter Senior Director, Training Vectech Pharmaceutical Consultants, Inc.

David A. Porter, Ph.D. was the Director of the General Chapters Group, Drug Standards Development at the United States Pharmacopeia. In that role, he was responsible for most of the general chapters in the USP. He arrived at USP in February of 2000, where he was involved in a broad range of biological aspects pertaining to both monographs and general chapters while in the Complex Actives division. Currently, he is Senior Director of Training at Vectech Pharmaceutical consultants, Inc.

He began his industrial career at Bausch & Lomb, where he managed the microbiology and toxicology areas. He also managed the biostatistics area in the clinical affairs group. His next industrial stop was as the leader of the biological science section of the Advanced Concepts area at the cosmetics company, Revlon. Numerous new analytical methods were developed in the pursuit of these actives. He was also a coinventer on two patents.

David A. Porter completed his doctoral work in Zoology at the University of California, Berkeley, with an emphasis in comparative endocrinology. His postdoctoral work included studies of the molecular biology of avian gonadotropic hormones, and mammalian parathyroid hormone and its receptors.

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Mr. Robert F. Guardino Director of Microbiology AAIPharma Inc.

Mr. Guardino is the Director of the Microbiology Lab for AAIPharma Inc. where he oversees a full-service contract Microbiology Laboratory in support of the Pharmaceutical and Biotechnology industries. After earning a Master of Science Degree from the University of Buffalo in Medical Technology with a concentration in Microbiology, he performed research in Microbiology and Biotechnology for several years and supervised an industrial microbiology lab for five years. Mr. Guardino has also held positions as a product development / quality assurance supervisor for rapid microbial diagnostic products and as a principal scientist during the development of PCR-based diagnostic products for a JNJ Company. His Quality System / Good Manufacturing Practice Regulations experience span 18 years. Areas of expertise include microbial contamination and control; microbial specifications for non-sterile and sterile dosage forms; drug substance, excipient, in-process and finished product microbiological testing requirements; release and stability requirements and testing; down-stream / purification process contamination and control for biotechnology products; disinfectant qualification; water system and environmental validation. He has presented seminars and workshops domestically and internationally on theory of microbiology testing, including recent training to FDA CDER and CBER branches.

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Ms. Deborah A. Brusini Vice President of Product Management & Marketing Rapid Micro Biosystems, Inc.

Deborah Brusini, VP Product Management and Marketing, has more 25 years experience in the life science research, diagnostic and biopharmaceutical marketplaces. In her current position she spends significant time with clients helping them to develop their business case for the implementation of Rapid Micro Biosystems rapid testing technology into their organization. Deb most recently came from PerkinElmer Life and Analytical Sciences, where she held multiple leadership positions in several capacities including product management, sales, and market development. Prior to PerkinElmer, she held leadership positions with New England Nuclear and DuPont. Deb has a B.Sc. in Biochemistry from Clemson University.

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Mr. David Jones Director of Technical Services Rapid Micro Biosystems, Inc.

David Jones, Director of Technical Services, has more than 20 years experience in analytical method development, validation and equipment optimization in the diagnostics industry, with a number of start up companies including Unipath. David then spent six years at Chemunex where he introduced rapid microbiology methods to the market as Director of QA and Regulatory Affairs. More recently David was at Wyeth Biopharma leading the evaluation and validation of rapid micro methods and new technologies to improve laboratory efficiencies. David has a BSc in Biochemistry and a PhD from London University in steroid endocrinology.

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Day 1 - Wednesday April 7, 2010
08:00 AM - 08:30 AM	Registration and Continental Breakfast
08:30 AM - 10:30 AM	Microbiological Best Lab Practices (USP <1117>) - NEW DRAFT
	Control of test strains Proper preparation, storage and control of growth media Data evaluation and result interpretation Training of laboratory staff Aseptic technique - a fundamental in all forms of analysis. Laboratory layout Changes in the New Harmonized Microbial Limits Tests: USP <61>, <62>, and <1111> Differences between previous <61> and harmonized <61> Differences between previous <61> and harmonized <62> Differences between previous <1111> and harmonized <1111> Recent changes to harmonized <61>, <62> and <1111>
10:30 AM - 10:45 AM	Mid-Morning Refreshment Break
10:45 AM - 12:00 PM	Characteristics of Microorganisms encountered in the Pharmaceutical Microbiology Lab
	The most common types of microbes encountered in the Pharmaceutical Microbiology Laboratory include Bacteria Fungi Mycoplasmas Viruses Cellular organization, function Products; toxins, endotoxins, antibiotics, enzymes This session will discuss how these microbes differ in their structure, composition, mode of replication, nutritional requirements, growth conditions, and host associations. With this fundamental understanding, we can explore: where we will find them when we will find them how often we will encounter them how we will detect them how we will identify what we recover This session will assist the Pharmaceutical Microbiology Lab in establishing best practices to account for the wide range of microbes that may be encountered. Microbial Growth How it occurs What is required for growth? Growth kinetics – laboratory culture versus nature Effect of stress factors on growth
12:00 PM - 01:15 PM	Luncheon
01:15 PM - 02:15 PM	Efficacy of Antimicrobial Preservation	DAY ONE Parallel Workshop & Tutorial Validation of Microbial Test Methods
	The Purpose of the AET What the test is USP Pharm Eur Development of the USP Test Demonstration of Method Suitability Other considerations in preservation Container/Closure In-use Testing	Pharmacopeial Requirements Setting Appropriate Acceptance Criteria Microbial Method Validation: Theory and Practice Case Studies Validation Protocols  Round Table Discussions: Objectionable organisms in pharmaceuticals
02:15 PM - 03:15 PM	Microbial Identification Techniques
	What is the significance of a name? Distribution of microorganisms in nature, raw materials and water Distribution of microorganisms in pharmaceutical facilities How to develop robust microbial identification program
03:15 PM - 03:30 PM	Mid-Afternoon Refreshment
03:30 PM - 04:30 PM	Building a Business Case for a Rapid Micro Method
	The challenge of capital purchases for the Micro QC lab Using a credible process to elucidate value Articulating the “right” information and translating features and benefits of rapid micro technology into financial payback Bringing forward a credible ROI and Business case
04:30 PM - 05:30 PM	Building a Business Case for a Rapid Micro Method
	OOS vs Microbiological Data Deviation (MDD) Environmental Monitoring Excursions The Lab Investigation CAPA
05:30 PM - 05:45 PM	Questions & Answers
05:45 PM	Conclusion of Day One
06:00 PM - 07:00 PM	Networking, Wine & Cheese Reception
Day 2 - Thursday April 8, 2010
08:00 AM - 08:30 AM	Continental Breakfast
08:30 AM - 09:30 AM	Microbial Identification (NEW USP <1113>)
	The need for microbial identification Phenotypic Identification Methods Genotypic identification methods Criteria for Verification of Identification Methods
09:30 AM - 10:30 AM	Detection Methods and Their Limitations
	What can be detected by: The sterility test The bioburden test in its various forms: membrane filtration, pour plate, spread plate, MPN The test for specified organisms The endotoxin test Limits of detection and factors effecting limits of detection
10:30 AM - 10:45 AM	Mid-Morning Refreshment Break
10:45 AM - 12:15 PM	Development of an Effective Disinfectant Evaluation Program
	Effective evaluation of disinfectants is an integral part of an overall microbial contamination control program. This session will discuss: why to test what guidance is available types of studies to be conducted (suspension-kill assays, surface testing & in situ evaluation) how to select agents and criteria for their testing how to determine surfaces and prepare coupons methods of agent application types of microbes for study selection of recovery test methods interpreting results, and potential problems areas to consider The need to consider disinfectant evaluation in Microbial Excursion Investigations will also be presented.
12:15 PM - 01:30 PM	Luncheon
01:30 PM - 02:45 PM	Validation of Microbiological Rapid Methods (RMM)	Parallel Workshop & Tutorial Sterilization and Sterility Assurance
	Overview of the spectrum of Rapid Micro Technologies available Validation strategy differs according to technology, discussion Data from an example system validation will be presented	Limitations of current sterility testing (<71>) Sterilization and sterility assurance of compendial articles Terminal sterilization Modes of sterilization Validation of sterilization processes Parametric release
02:45 PM - 03:00 PM	Mid-Afternoon Refreshment
03:00 PM - 05:00 PM	Tutorial: Sterility Test Validation and Critical Parameters
	Understanding the Sterility Test Regulations and Guidance Bacteristasis / Fungistasis Testing Sterility Testing and Test Failures
05:00 PM - 05:15 PM	Questions & Answers
05:15 PM	Conclusion of the course

 

This two day course and workshops is directed toward Directors, Managers, Supervisors, and Associates in the Pharmaceutical, Medical Device, and allied industries with daily responsibilities in the following areas:

• Microbiology
• Validation
• Technical Operations
• Validation
• Quality Assurance
• Quality Control
• Change Control
• CAPA Management
• GMP/GLP Compliance
• Regulatory Affairs
• R&D
• Product Submission
• Training
• Engineering
• Production
• Engineering
• Facility Monitoring
• Contract manufacturing
  

 

Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments

Cancellation/Substitutions Policy:

All cancellations are subject to a USD $150.00/person processing fee. To receive cancellation credits for attendance at an upcoming course, IPA must be notified of the cancellation in writing (by email, mail or fax) up to 3 weeks prior to the program start date. Cancellations submitted less than 3 weeks prior to the event will not be qualified for refund or credit. Substitution of delegate/s with the member/s of the same organization is permitted at any time with no penalty.

IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.

Hotel Accommodation The Yorkland Hotel 185 Yorkland Boulevard Toronto, ON Canada M2J 4R2 Tel: 416 -493-9000 or 1-800-567-8500

A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention IPA to receive the reduced room rate.  For more information, please call us at 416-410-7402 or enquiry@ipacanada.com