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

2. 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

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

4. 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.

5. 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

6. 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.

7. 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

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

9. Questions/Comments?

10. More information: https://www.fda.gov/default.htm
UCM pdf

11. Contact Information:
Robin Finnell -
Josh Richards -
Julie Deutz -