ANN ARBOR — The Center for Professional Innovation and Education, the Malvern, Pa.-based provider of technical training for the life sciences industry. and MichBio, the statewide biosciences industry association for Michigan, announced a partnership that will offer MichBio members a 15 percent discount off CfPIE’s training curriculum and certification programs.

“Our alliance with CfPIE extends both cost-savings and a quality resource for our members to meet professional development and compliance requirements, while capitalizing on personal career growth opportunities,” said Stephen Rapundalo, president and CEO of MichBio.

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MichBio members will benefit from multiple training formats: * Two- and three-day classroom training that provides detailed topic coverage along with opportunities for one-on-one contact with industry-active course directors * On-site training that delivers economies for groups, travel savings, content customized to corporate needs, and a consistent experience for all company employees in attendance * Multi-course certification programs that enable individuals to tailor the qualifying courses of study, leading to certification according to their personal and professional needs

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Specific bioscience training courses include: cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices; CMC Regulatory Compliance for Biopharmaceuticals and Biologics; Preparation of FDA Submission and Communicating with the FDA; and Comprehensive Overview of FDA Regulatory Compliance.

MichBio members will learn how to:
* Better understand regulatory agency expectations and how to avoid pitfalls for development and validation of bioanalytical assays for biologics
* Ensure adherence to CMC regulatory compliance for biologics and biopharmaceuticals 
* Appreciate the regulatory challenges of biosimilars, and the FDA, EMA and WHO perspectives on them
* An overview of the FDA’s procedures, guidances and regulatory pathways that affect review of potential products, and how to hold meetings with the agency

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More at www.cfpie.com or www.michbio.org.