New Curriculum Part of PerkinElmer’s Comprehensive Solutions to Meet Customers’ Educational Needs with High Quality, Convenient, Consistent Training
WALTHAM, MA -- April 25, 2007 -- PerkinElmer, Inc. (NYSE: PKI), a global leader in Health Sciences and Photonics, today announced new online curriculum to support customers in the pharmaceutical, clinical and other heavily regulated industries with training on regulatory compliance topics.
The curriculum is part of PerkinElmer’s ongoing commitment to provide comprehensive service and support to enable laboratories to advance the pace and precision of their product development and testing. The training offerings complement PerkinElmer’s OneSource® compliance and validation services which specialize in robust solutions that maximize laboratory productivity.
“PerkinElmer’s online curriculum offers professionals the convenience and flexibility they need to access training on demand while offering employers the assurance that their personnel are trained in a consistent manner with proven effective techniques and mission-critical content,” said Ralph Dioguardi, global training leader, PerkinElmer Life and Analytical Sciences. “The compliance modules complement PerkinElmer’s other training resources and aid customers in their efforts to secure and maintain certifications.”
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 www.perkinelmer.com/training.
Factors Affecting Future Performance
This press release contains “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities. Words such as “believes,” “intends,” “anticipates,” “plans,” “expects,” “projects,” “forecasts,” “will” and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management’s current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) our failure to introduce new products in a timely manner; (2) our ability to execute acquisitions and license technologies, or to successfully integrate acquired businesses and licensed technologies into our existing business or to make them profitable; (3) our failure to protect adequately our intellectual property; (4) the loss of any of our licenses or licensed rights; (5) our ability to compete effectively; (6) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (7) our ability to produce an adequate quantity of products to meet our customers’ demands; (8) our failure to maintain compliance with applicable government regulations; (9) regulatory changes; (10) economic, political and other risks associated with foreign operations; (11) our ability to retain key personnel; (12) restrictions in our credit agreement; (13) our ability to realize the full value of our intangible assets; and (14) other factors which we describe under the caption “Risk Factors” in our most recent annual report on Form 10-K and in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Other Information
Health Sciences end markets include genetic screening, environmental, service, biopharma, and medical imaging. Photonics markets include sensors and specialty lighting.