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

UPCOMING

Accelerated Technology Laboratories and Microsoft are hosting a free seminar entitled LIMS: The Key to Streamlining Lab Operations and Staying Compliant at Microsoft’s Los Angeles, CA offices on Wednesday, September 24, 2008 from 11:30AM – 1:00PM. The 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 (air/water/soil), analytical (material/product testing), agriculture, chemical, food & beverage, life sciences and government (public health). For details, visit http://www.clicktoattend.com/invitation.aspx?code=130786.

Manager’s Guide to Lab Automation & Technology Management will be held at the Radisson Hotel in Nashua, NH from September 30 - October 2. The purpose of this short-course is to introduce management to lab automation: what it is, management’s role in laboratory automation, the policies that need to be developed to help ensure successful projects, models of laboratory work that can be used to define automation needs and product requirements, and an overview of the technologies used. For details, visit http://www.Delphinus-LAE.com/course.

Co-Sponsored by DIA and FDA, FDA Critical Path Initiative (CPI) on the Move will be held in Bethesda, MD from September 15 - 16. Participate in breakout sessions with FDA's National Center for Toxicological Research (NCTR), Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER), and gain a unique perspective from FDA Center Directors. For details, visit http://www.diahome.org.

PerkinElmer will host a series of LABWORKS LIMS Webcasts targeted to laboratory information management systems (LIMS) users in a variety of industries, including geochemical, mining, environmental, agriculture and food and beverage. The Webcast topics range from LIMS basics to industry-specific applications. They are available at no cost to laboratory professionals. Topics include:
- September 18, 2008, 2:00 p.m. (EST) – Planning your LIMS Data Migration: What to prepare and what to require when changing systems
- October 8, 2008 2:00 p.m. (EST) – LIMS at the Florida Dept. of Agriculture: Enhancing communication with your customer (part 1 of 2) Laboratory Services
- October 9, 2008 2:00 p.m. (EST) – LIMS at the Florida Department of Agriculture: Enhancing communication with your customers (part 2 of 2) Field Inspectors
- November 13, 2008, 2:00 p.m. (EST) – LIMS Innovation: Taking wine-making into the 21st century
For more information, or to register for a Webcast, please visit http://las.perkinelmer.com/labworks/webcasts.html.

PACS will be holding a LIMS Short Course in San Jose, CA from September 15-17 and in Pittsburgh, PA from October 29-31. The course will be taught by industry consultant Dr. Marty Goffman and will address processing efficiency, quality assurance, and data validation. For details, visit http://pacslabs.com/courses/340labinfomanagementsyscourse.php.

Conducting Effective Auditing of GMP Documentations will be held in Toronto, Canada from September 10-11. A compliant documentation system is of vital importance to a pharmaceutical company because it supports various important functions. It provides the legal proof that work was adequately planned and performed, it helps in the trouble-shooting of technical and managerial problems, it facilitates company growth and technology transfer, it provides a written history of company and products, and it proves to regulators that the company follows its commitments. This training course provides participants the tools needed to perform in-depth audits of GMP documentation in the pharmaceutical, biopharmaceutical and medical devices including insight on new regulations and methodologies, case studies to help benchmark current practices, and guidelines for following up with corrective actions. For details, visit http://www.aaps.ca/semauditinggmp.html.

Introduction to GMPs and Supporting Quality Systems will be held in Toronto, Canada from September 16-17. The course is designed to provide an introduction to Good Manufacturing Practices and the key quality systems essential to GMP compliance in the pharmaceutical and related industries. The course material is based on current Health Canada and FDA guidelines. This course is presented in a dynamic environment created by a power point presentation, interactive exercises, and group discussion. The final session includes a fun, team trivia quiz to help solidify new learnings. For details, visit http://www.aaps.ca/semintrogmp.html.

PerkinElmer, Inc. has announced new online curriculum to support customers in the pharmaceutical, clinical and other heavily regulated industries with training on regulatory compliance topics. The training offerings complement PerkinElmer’s OneSource compliance and validation services which specialize in robust solutions that maximize laboratory productivity. The new e-learning curriculum includes:
• Good Clinical Practice (GCP) Level 1 – This course covers the ethical and scientific quality standards for designing, conducting, recording and reporting human clinical trials. GCP compliance ensures the protection of the rights, safety and well-being of trial participants and the credibility and integrity of clinical trial data. Content includes a review of clinical trials, GCP guidelines and informed consent.
• Good Clinical Practice (GCP) Level 2 – Level 2 includes a review of the standards used in clinical studies from start-up to post-study audits. The function of independent review boards, recording and reporting of adverse events and the de-qualification process are among the topics covered.
• Good Manufacturing Practice (GMP) – Participants receive an introduction to the concepts and requirements necessary for compliance with GMP for pharmaceutical and biopharmaceutical research and development. Students will review how to establish and document a system of GMP controls required to manufacture drug products in the United States, the European Union, Japan and many other parts of the world.
• Good Laboratory Practice (GLP) – This is an introductory course focusing on the concepts and requirements necessary for compliance with GLP research and development. It will address how to establish and document a system of GLP controls required to test medical products where data is intended for inclusion into a regulatory filing in the United States, the European Union, Japan and in many other parts of the world.
• 21 Code of Federal Regulations (CFR) Part 11 – The curriculum covers the FDA’s “21 CFR Part 11,” which provides the set of rules for electronic signatures and electronic records. The course discusses why Title 21 was developed, the role it plays in adhering to other sections of 21 CFR and explores the general concepts of security in a Part 11-compliant system.
Once registered, a participant may access the media-rich, computer-animated training modules for up to 30 days from the convenience of their office or home. Each module takes approximately 60 to 90 minutes to complete and offers the chance to self-check understanding of the content. For details regarding curriculum and registration, visit http://www.perkinelmer.com/training.

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.