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.
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
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