“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,” says Stephen Rapundalo, PhD, 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
About CfPIE
The Center for Professional Innovation and Education (CfPIE) is the global leader in pharmaceutical, biotech, and medical device training within the life sciences industry. CfPIE offers more than 350 class sessions annually across 71 course titles. Multiple learning formats—classroom, customized on-site presentation and certification programs—provide individuals and companies versatile choices for improving personal skills, maintaining regulatory compliance, and creating opportunities for career advancement. Small class sizes and life science industry-active course directors promote a dynamic learning environment with excellent student-to-teacher interaction.
About MichBio
MichBio is the trade association committed to driving growth in Michigan's biosciences industry and its many sectors, including agri-biotech, food and nutrition, bio-based technologies and renewable chemicals, industrial and environmental biotech, medical devices and technologies, pharmaceuticals and consumer healthcare, diagnostics and research products, testing and research services, and clinical research. MichBio members include biosciences companies, academic and research institutions, biosciences service providers, and related organizations.
Media Contact:
Jaclyn Solick
TME Communications for CfPIE
610- 688-0659 x 114
jackies@tmecom.com
