LIMSource Calendar of LIMS, Informatics and Lab Data Automation Seminars and Short Courses

UPCOMING

The US Food & Drug Administration has announced that it will host a Public Meeting on Oversight of Laboratory-Developed Tests (LDTs) in order to obtain public input on reasonable and effective regulation to protect public health. The event will be held July 19-20 at the Crowne Plaza in Rockville MD. LDTs refer to in vitro diagnostics that are manufactured by and offered in the same laboratory. They include some genetic tests, and tests that may lead patients to make important medical decisions. Since the implementation of the 1976 Medical Device Amendments, the FDA has generally exercised its enforcement discretion and not enforced regulations that apply to LDTs. Initially, the FDA viewed LDTs as relatively simple, well-understood tests that diagnosed rare diseases and conditions, and that were intended to be used by physicians and pathologists in a single institution where they were actively involved in patient care. The tests were ordinarily well-characterized, low risk diagnostic tools. Over the last 15 years, the nature of LDTs has changed dramatically. Today, these tests are often used to assess high-risk, but relatively common diseases and conditions, and many are genetic tests. These tests are often performed in commercial laboratory settings that are geographically separate from the patient’s primary health care professionals and their health care setting. These tests, which are becoming more complex and high risk, are playing an increasingly important role in clinical decision-making. As a result, LDTs that have not been properly validated put patients at risk, such as for missed diagnosis, wrong diagnosis, and failure to receive appropriate treatment. Therefore, FDA believes that a risk-based application of oversight for LDTs is appropriate, and seeks public input on issues and concerns related to LDT oversight. During the two-day meeting, an overview of the history and current regulatory status of LDTs will be discussed. The meeting will also be divided into four sessions: 1. Patient Considerations 2. Challenges for Laboratories 3. Direct-to-Consumer Marketing of Testing 4. Education and Outreach Each session will consist of public presentations focused on each area and will be followed by an expert panel discussion and question-and-answer period. Specific details about the meeting will be published in the Federal Register consistent with applicable law and regulations. The FDA will collect and review all comments and information presented at the public meeting. Subsequently, the agency will move forward in developing a draft oversight framework for public comment with the goal of providing a level of predictability as quickly as possible. The FDA also intends to phase in such a framework over time based on the level of risk of the test. Registration: Online registeration for the conference is available. There is no registration fee to attend the meeting, but attendees must register in advance. Please submit registration early in order to reserve a space, as space is limited. For details, visit http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm212830.htm.

IPA's International API GMP Guidance: ICH Q7 Implementation and Application will be held in Montreal,Canada from August 17-18. The course theme is: Essential GMP Guide for API's For Pharmaceutical, Biopharmaceutical and Allied Industries. The comprehensive two-day program was developed along with FDA to train both regulatory (FDA) and Industry personnel. It was written by members of the ICH Q7A Expert Work Group and designed to teach both the meaning and intent of the API GMP. For details, visit http://www.ipacanada.com/viewcourse.php?id=ichq0810mon.

Autoscribe is offering a series of LIMS Configuration Workshops in several locations in the UK and Ireland. The workshops will include a demonstration of how the tools are used to define workflows, screens and menus, for example. As part of the workshop at least ten different configurations will be presented to illustrate the scope for meeting individual customer requirements without a line of code being written. For details, visit http://www.autoscribe.co.uk.

Accelerated Technology Laboratories and Microsoft are hosting a 2010 LIMS Seminar Tour and Webcast Series. This lunch event will explore the current challenges that are faced in the modern laboratory and demonstrate how organizations are automating operations to increase productivity and data quality while reducing operational costs. This seminar is ideal for lab operations or QA/QC managers in the following industries: environmental, water & wastewater, agriculture, manufacturing (material/product testing), food & beverage, life sciences and government (public health). For a current list of confirmed locations/dates and to register online, please visit: http://www.atlab.com/index.php/2010-LIMS-SEMINAR-WEBCAST-SCHEDULE.html.

Laboratory Automation for IT Professionals is available as an on-site course, no public offering has been scheduled as yet. This course is available in two forms: Option 1: one-day stand-alone course available as either a public offering or on-site course; or, Option 2: half-day course that serves as a preamble to the "Manager’s Guide to Lab Automation & Technology Management" course (listed above). It is recommended for on-site programs that include a combination of both this half-day session and the Manager’s Guide course. The half-day session is intended to provide an introduction to lab instrumentation. Why is this course important? Laboratory computing is essential to the operation of R&D and quality control labs. While some aspects (office applications) are similar to other groups in the company, labs have unique computing and regulatory requirements that may not be covered by traditional IT policies. An understanding of laboratory requirements will help both IT and lab groups develop policies for support, product selection, and the integration of the lab into the general corporate computing environment. These short-courses will introduce IT professionals to lab automation, what it is, what the processes are, how labs work [research, QC examples], the state of data interchange standards, LIMS, ELN, instrument automation and instrument data systems, the use of robotics, and regulatory issues. For details, visit http://www.institutelabauto.org/LAE-SC-2/index.htm. or http://www.institutelabauto.org/courses/PublicSchedule.html

ONGOING

The following organizations offer courses year-round on a variety of topics. A brief summary is provided of some of the available courses. For more information, contact the organization directly.

American Society of Organic Analytical Chemists (AOAC)

American Society for Quality (ASQ)

Caliso Worldwide Training & Consulting

CEEM

Center for Quality at Eastern Michigan University

DCI

Excel Partnership, Inc.

Guelph Food Technology Centre

Information Mapping

PACS, Inc

Pharmaceutical Education & Training Institute (PERI)

PTi International

Sira Test & Certification

Software Certification Institute

Softwire Technologies

Stat-A-Matrix Institute

Thermo LabSystems

University Associates of Princeton

Waters Corporation

Yankee Engineering Services

The American Society of Organic Analytical Chemists (AOAC) offers many training courses, including ISO 17025 Management Systems for the Laboratory, Principles of Statistics and Uncertainty, Quality Assurance for Microbiological Laboratories, Quality Assurance for Analytical Laboratories, and Auditing ISO Management Systems. Courses are typically two days and cost less than $1000. For details and a complete list of courses, visit http://www.aoac.org.

The American Society for Quality (ASQ) holds a number of quality-related courses including three different courses on Auditing and Supplier Quality; five courses on Customer Satisfaction and Service Quality; 10 courses on Engineering/Statistics that include SPC and Software Quality Engineering; four ISO 9000 courses; two ISO 14000 courses; a QS-9000 course; and more. The classes are held at various locations around the US and usually run two to four days. For more details, contact the ASQC at (800) 248-1946 or (414) 272-8575, or by fax (414) 272-1734 or visit http://www.asq.com.

Numerous ISO 9000 and other quality issues seminars and training classes are hosted by CEEM and taught by the British Standards Institute throughout the U.S. Courses include Understanding ISO 9000 (2 days; $595); Auditing to ISO 9000 (3 days; $1095); Documentation (2 days; $895); Internal Auditor (2 days: $895); Auditor/Lead Auditor (4.5 days; $1595), and more. For details and a copy of their catalog, contact CEEM at (800) 745-5565 or (703) 250-5900 or fax (703) 250-5313.

The Center for Quality at Eastern Michigan University offers numerous Quality, Reliability, and Productivity Improvements Seminars. Topics cover various quality systems; tooling and equipment; reliability and planning; improvement facilitation; statistical methods, and service. For details and a copy of their course catalog, contact the Center for Quality at Eastern Michigan University at (313) 487-2259 or (800) 932-8689 or visit their web page at http://www.emich.edu.

An Andover, MA organization called DCI that specializes in Computer Software Education offers a number of interesting seminars on topics such as client/server systems; object oriented analysis and design; business process reengineering; and databases and data warehouses. Average cost per course is $1000. To receive a copy of their catalog, call (508) 470-3880 or surf their web site at http://www.DCIexpo.com

Excel Partnership Inc specliaizes in ISO 14000 courses, including courses on ISO 14000 Overviews, Developing and Implementing an ISO 14000 EMS, and EMS Internal Auditor. For a complete list of courses, dates, and locations, contact Excel at (800) 374-3818, or surf their web site at http://www.xlp.com.

The Guelph Food Technology Centre in Ontario, Canada offers a wide range of symposia and short courses for food and agri-food professionals. New programs for 2002 include Food Safety and HACCP Auditor Certification as well as HACCP Accreditation. Other courses include technical training in Sanitation and Microbiology, Food Safety and HACCP, as well as customized in-house training in bakery, dairy, grocery and meat products. Audits and Consulting services are also available. For details, visit http://www.gftc.ca.

Information Mapping offers a number of seminars relating to analyzing, organizing and presenting information so it is easy to access, use and understand. Courses include Documenting Pharmaceutical and Medical Device Procedures, and Documenting for ISO/QS 9000. The classes are held at various locations around the US and usually run two days. Prices are in the $1,000 to $1,300 range. For details, call (800) 518-6674, or visit their web site at http://www.infomap.com.

PACS, Inc. offers numerous courses around the U.S., and hosts the occasional exposition. Courses include: Quality Assurance of Chemical Measurements, Quality Assurance of Environmental Measurements, Environmental Laws Compliance, and Environmental Data Validation. For details and course descriptions, contact Barbara Sherman, PACS Inc., 409 Meade Drive, Coraopolis, PA 15108. Tel: (412) 457-6576 or (800) 367-2587. Fax: (412) 457-1214. Web: http://members.aol.com/hnpacs/pacs.htm.

Pharmaceutical Education & Research Institute (PERI) provides training in the development, review and approval processes for healthcare products. Courses cover topics from research, development, manufacturing, marketing and post-marketing surveillance of healthcare products and include data information management and analysis courses such as Clinical Data Management, Computer Validation, Electronic Records and Signatures, and Non-Clinical Statistics for Drug Development. For details, contact PERI at 1616 North Fort Myer Drive, Suite 1430, Arlington, VA 22209, USA. Tel: (703) 276-0178. Fax: (703) 276-0069. Web: http://www.peri.org.

PTi International provides Quality and Compliance training for the pharmaceutical, biotechnology, medical device and drug delivery industries. They offer small, interactive classrooms and can also customize courses to all competency levels in need of on-site training. PTI's broad knowledge of core curriculum can help companies map out their company's training plans that adhere to FDA requirements for training their staff. Not only can PTI tailor training to a company's needs by adapting an existing program, developing a new course or mapping out a training plan, but they can also work with companies to develop ways to measure post-training performance improvement. For details, visit http://www.pti-international.com.

SIRA Test and Certification Ltd offers a range of Conformity Assessment Solutions including certification, training and compliance testing. The company offers training courses on a recurring basis throughout the year. Of interest are the courses on Laboratory Accreditation and ISO 17025 Familiarisation Workshop All courses are held at Sira, South Hill, Chislehurst, Kent, BR7 5EH. For further information and a free-of-charge Training leaflet, please contact Isobel Smith or Pat Blazdell at +44 020 8467 2096 or e-mail siratraining@siratc.co.uk or visit http://www.siratraining.co.uk.

Three courses on ISO 9000-3 (the ISO standard covering software quality) are offered by the Software Certification Institute. Taught by Dr. Leo Egan, these courses include Simplifying ISO 9000-3; ISO 9000-3: Key to Quality Software and Global Success; and, Software Quality Assurance to ISO 9000. For details -- including dates, locations, and costs -- contact the Software Certification Institute, P.O. Box 2328, Santa Maria, CA, 93457. Tel: 805-937-5383.

Softwire Technologies offers Technical Briefings and hands-on training sessions throughout the year on their Softwire products. The free one-day, 9:00 to 4:00 seminars provide and Introduction to Softwire and the Softwire Control Suite. For details, visit http://www.softwiretechnology.com.

Stat-A-Matrix Institute hosts a number of quality-related courses for business process improvement including courses on ISO 9000 programs, such as auditor/lead auditor training; Concepts and Principles of Process Validation; FDA-Regulated Medical Device Industry Training; and ISO 14000. The classes are held at various locations around the US. For details, call the Stat-A-Matrix Institute at +1 800-472-6477 or visit their website at http://www.statamatrix.com.

Thermo LabSystems offers continual LIMS training at their Training Centers in Altrincham, UK and in Beverly, MA in the US. Courses include Introduction to SampleManager, Infomaker for SampleManager and Managing Nautilus. CBT is now available for most courses. For details, visit http://www.thermolabsystems.com.

The University Associates of Princeton offers a number of courses throughout the U.S. on Applied Statistics, Regression Analysis, Empirical Model Building and more. For details, contact the University Associates of Princeton at P.O. Box 541, Princeton, NJ 08542. Tel: (609) 924-5624. Fax: (609) 924-5656. Web: http://www.pcnet.com/~uapinet.

Waters Corporation offers numerous courses covering a variety of chromatography topics, including Method Validation for HPLC, Chemistry of Resolution, Bioseparations Development, Millennium 2020 Client/Server Training, and more. For details, and to find out when and where the next seminar will be held, contact Waters at 508-482-8701 or 800-252-4752 x8502, or surf their web site at http://www.waters.com.

Yankee Engineering Services offers numerous courses and workshops on ISO 14000 throughout the U.S. Course fees range from $895 to $1850 depending on the type and length of course. For a list of course offerings, contact Yankee Engineering Services at 580 Main Street, Bolton, MA 01740. Tel: 508-779-6711. Fax:508-568-3704. Email: iso14000@yankee.com.