New curriculum part of PerkinElmer’s comprehensive solutions to meet customers’ educational needs with high-quality, convenient, consistent training
May 3, 2007 — WALTHAM, MA — PerkinElmer, Inc., a global leader in Health Sciences and Photonics, has 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(R) 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.
PerkinElmer, Inc. is a global technology leader focused in the following businesses — life and analytical sciences, optoelectronics, and fluid sciences. Combining operational excellence and technology expertise with an intimate understanding of its customers’ needs, PerkinElmer creates innovative solutions — backed by unparalleled service and support — for customers in health sciences, semiconductor, aerospace, and other markets whose applications demand absolute precision and speed. The company markets in more than 125 countries, and is a component of the S&P 500 Index. Additional information is available through www.perkinelmer.com or 1-877-PKI-NYSE.