FDA Regulated Special Interest Group Robin Finnell – Tillamook County Creamery Association Josh Richards – Merit Solutions Julie Deutz – Dynamic Communities

Who is regulated by the FDA? Regulated Product Find Information about: Human Foods Foods for human consumption, including dietary supplements, and color additives Human Drugs Active pharmaceutical ingredients and both prescription and over-the-counter medications Vaccines, Blood and Biologics Biologic products such as human blood, blood donor screening tests, human tissue, embryos, human plasma, and medical devices for use in blood banking operations Medical Devices Medical devices such as first aid kits, pacemakers, and surgical instruments Radiation-Emitting Electronic Products Radiation-emitting products such as x-ray machines, microwave ovens, CD-ROMs, and laser pointers Cosmetics Cosmetic products such as shampoo, make-up, and face creams Animal and Veterinary Animal food and feed as well as veterinary medicines Tobacco Products FDA-regulated tobacco products such as cigarettes, smokeless tobacco, e-cigarettes and other electronic nicotine delivery systems, cigars, and all other tobacco products

Poll: What FDA regulated program does your company fall under?

FDA Regulations May Include: Regulations That Affect All Life Sciences 21 CFR Part 11 Physician Payments Sunshine Act Software Validation Regulations That Affect Human Food FSMA cGMPs HACCP Medical Devices Unique Device Identification (UDI) IDE (Investigational Device Exemption) Medical Device Reporting Biologics CBER HCT/P Inspections Drug Supply Chain Security Act (DSCSA) 21 CFR Part 11 – Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Primarily pertains to the use of audit trails and electronic signatures. Physician Payments Sunshine Act – Requires medical products manufacturers (pharma, biologics, med device) to disclose to the federal government any payments or other transfers of value made to physicians or teaching hospitals. Software Validation - A process used to ensure (and document) that a computer-based system will produce information or data that meet a set of defined requirements. It confirms the systems work the way they should. FSMA – Food Safety Modernization Act CGMP – Current Good Manufacturing Practices HACCP – Hazardous Analysis and Critical Control Points Unique Device Identification (UDI) - intended to assign a unique identifiers to medical devices, that include lot or serial number, that can then be tracked through distribution and use. Again, this is meant to help limit fraud / counterfeit products and speed recalls. IDE – refers to clinical trials CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. HCT/P - human cells, tissues, and cellular and tissue-based products (HCT/Ps) Drug Supply Chain Security Act (DSCSA) – Intended to help identify and trace certain prescription drugs as they are distributed. This is meant to help limit fraud / counterfeit products and speed recalls.

Why do we need a FDA Regulated SIG? FDA is responsible for the oversight of more than $2.5 trillion in consumption of food, medical products, and tobacco. FDA-regulated products account for about 20 cents of every dollar spent by U.S consumers. Total # of Facilities by Program FDA Program Total # of Regulated Facilities Animal Drugs 1,788 Animal Food 24,577 Biologics 6,996 Human Drugs 10,351 Human Food 193,377 Medical Devices 26,900 Tobacco 3,039 Total 267,028

Why do we need a FDA Regulated SIG? In FDA regulated industries, standards are constantly shifting and changing. This makes compliance extremely challenging, and it becomes more difficult to avoid incurring fines. Moreover, there is also a very real threat to a company’s brand and reputation should a mishandled recall occur. This SIG can provide a venue for learning and sharing within the user group, to gain a better understanding of how AX/D365 can work for us. When we come together as an organized Special Interest Group we, as users and customers, have a louder voice with Microsoft.

Virtual Learning Opportunities What kind of content is meaningful to you? What would you be interested in learning more about? Some ideas may include: Quality Compliance Validation in the Cloud Product Recall

Poll: Would you be willing to attend Summit US a day early for onsite training specific to the FDA Regulated SIG?

Questions/Comments?

More information: https://www.fda.gov/default.htm https://www.fda.gov/downloads/AboutFDA/Transparency/Basics/ UCM617928.pdf

Contact Information: Robin Finnell - rfinnell@tillamook.com Josh Richards - jrichards@meritsolutions.com Julie Deutz - julie.deutz@dynamiccommunities.com