Panelists from FDA, Pfizer, NSF Health Sciences, Foley Hoag and Dynamic Computer Corporation, adjunct to Conference & Expo

MichBio, the association for Michigan’s biosciences industry, welcomes bio and life science professionals to its Bioscience Regulatory Compliance Workshop on Tuesday, January 17^th, 2017 at the Radisson Plaza Hotel in Kalamazoo, Michigan.

This event is adjunct to the MichBio Conference and Expo on Wednesday, January 18^th, 2017.

This half-day workshop is designed for bioscience OEM and contract manufacturing professionals working in the biopharma and medical device sectors. It will describe valuable best practices and discuss case studies to highlight common experiences in the field.

“We’re excited to feature the caliber of industry experts, such as the FDA District Director, who can share firsthand expertise on a broad range of regulatory compliance topics”, said Stephen Rapundalo, CEO of MichBio. “The event should appeal to a spectrum of bio-industry practitioners, especially as the business and product regulatory environment continues to become more burdensome.”

Ensuring a high standard of regulatory compliance is an essential business practice throughout the biosciences industry. Corporate compliance has a wide variety of touchpoints throughout a pharmaceutical or medical device corporation, from ensuring adherence to FDA regulations during product development, manufacturing and post-market surveillance to sales teams interacting with healthcare professionals, and senior leadership remaining compliant with SEC and FCPA regulations.

The Biosciences Regulatory Compliance Workshop is meant to provide an overview of timely and relevant issues such as managing interactions with the FDA, developing and maintaining compliance processes and a trained workforce, ensuring that suppliers and distributors conform to regulations, maintaining data integrity, and more. Attendees will hear from seasoned bioscience industry and government regulatory experts and surely walk away better informed on regulatory compliance matters that can impact their own organizations.

The workshop will include the following topics and experts:

• Establishing a Compliant Biosciences R&D and Manufacturing Organization– Armando Bombino, Executive Director, NSF Avarent, an NSF Health Sciences Company
• Role of Regional FDA Offices in Compliance and Enforcement– Arthur Czabaniuk, District Director, S. Food & Drug Administration
• HIPAA, Industry-Provider Interactions, and Other Compliance Matters– Colin Zick, Partner, Foley Hoag
• Maintaining IT System Integrity Through the Device Product Lifecycle– Farida Ali, President and CEO, Dynamic Computer Corporation
• Bringing it all Together: Corporate Audits and Compliance– Mark Ferin, Senior Manager, Corporate Audit, Pfizer 

“Whether you’re in the regulatory or quality assurance disciplines directly or want be better educated about overarching processes and regulatory framework”, Rapundalo added, “the Workshop is not to be missed.”

The workshop will begin with on-site registration and a networking lunch between 11:00am – 12:30pm in the Conference and Expo Innovation Hall and close with a networking reception from 5:30pm – 7:30pm, which will permit interactions between attendees and speakers. The full agenda and schedule can be found on the MichBio event calendar.

This event is adjunct to the MichBio Conference and Expo sponsored by the Michigan Economic Development on Wednesday, January 18^th, 2017, also at the Radisson Plaza Hotel in Kalamazoo, Michigan.

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 bioscience companies, academic and research institutions, bioscience service providers, and related organizations. For more information, visit www.michbio.org or follow us on Twitter @MichBio.

MichBio

Event Details

• Date: Tuesday, January 17, 2017 
• Time: 12:30 pm - 7:00 pm
• Location: MichBio

  Radisson Plaza Hotel 100 W. Michigan Ave. Kalamazoo, Michigan  49007