1. American Society for Quality Region 5 Quality Conference
Darning the Quality Safety Net
CDR Gayle Lawson, Pre-Approval Manager U.S. Food & Drug Administration Philadelphia District October 25, 2017

2. US Food & Drug Administration
FDA Mission Statement  
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
FDA is also responsible for advancing the public health by helping to speed innovations that  make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.
FDA also has responsibility for regulating the manufacturing, marketing  and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

3. www.fda.gov Office of the Commissioner
Office of Foods and Veterinary Medicine
Center for Food and Applied Nutrition
Center for Veterinary Medicine
Office of Global Regulatory Operations and Policy
Office of Regulatory Affairs
Office of Medical Products and Tobacco
Center for Drug Evaluation and Research (CDER)
Center for Devices and Radiological Health (CDRH)
Center for Biologics Evaluation and Research (CBER)
Center for Tobacco Products
Office of Operations
Office of Policy Planning Legislation and Analysis

4. FDA/ORA Structure
FDA consists of Centers and Offices, commodity-based located in vicinity of Washington, DC.
Center for Drug Evaluation and Research (CDER)
Center for Food and Applied Nutrition (CFSAN)
Center for Veterinary Medicine (CVM)
Center for Devices and Radiological Health (CDRH)
Center for Biologics Evaluation and Research (CBER)
Center for Tobacco Products (CTP)
Office of Regulatory Affairs (ORA) personnel and work offices located throughout the US (and globally) to conduct face to face operations with regulated industry including inspections, facilitate recalls, compliance corrections, etc.
Mission
Protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.

5. Office of Regulatory Affairs
Associate Commissioner
Office of Pharmaceutical Quality Operations
Office of Medical Devices and Radiologic Health Operations
Office of Biological Products Operations
Office of Bioresearch Monitoring Operations

6. Office of Regulatory Affairs Program Alignment
Regroup of ORA structure/personnel to commodity-based operations from historically geographic district/region operations
Vertically-aligned, ORA to Centers
Divisions, rather than District
Transition period

7. Pharma

8. Medical Devices

9. Bioresearch Monitoring

10. FDA Authority/Jurisdiction
Food Drug & Cosmetic Act
Code of Federal Regulations (CFR)
FDASIA: Food Drug Administration Safety and Innovation Act
New authorities to address the challenges posed by increasingly
global drug supply chain
Section 705: Risk-based Inspection Frequency
Section 706: Records for Inspection outside of an on-site inspection
Section 707: Prohibition against delaying, denying, limiting, refusing inspection
Section 710: Exchange of Information (enter agreements with foreign govt)
Section 712: Recognition of Foreign Government Inspections
DSCSA: Drug Supply Chain Security Act
Guidances, FDA current thinking on how to comply with law
Contract Manufacturing Arrangements for Drugs: Quality Agreements
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

11. Quality and Problem Management
What happens when your quality system fails you? What happens when something slips through the cracks of the quality safety net? How do we go back and mend the threadbare parts of our quality system?

12. Identify
Assemble supplies
Obtain instructions
Execute-darn it
Marvel at your work

13. Mending the Quality Safety Net

14. OOS and investigations Rejected batches Regulatory Audit deficiencies
1. Identify Weaknesses
OOS and investigations
Rejected batches
Regulatory Audit deficiencies
Enforcement Actions- your own/industry WLs
Complaints
Packaging Mix-ups
Labeling errors
Internal audit program

15. Problem Management Math Level 1 + Level 1 = Level 2 Level 1 + Level 1 + Level 1 = Level 3
Minor
+ Minor
Major

16. Understand exact root causes, contributing factors
2. Assemble Resources
Understand exact root causes, contributing factors
Build cross-functional teams
Provide training
Improve collaboration, internal & external
Obtain expert/additional resources

17. Change Control – GMP/non-GMP SOPs and other documents
3. Improvement Planning
Change Control – GMP/non-GMP
SOPs and other documents
External Contracts
Interdepartment/facility agreements

18. 4. Execute Changes Review and assess project.
Qualified persons’ authorization.
Quality Unit authorization.

19. 5. Marvel/Celebrate Accomplishments
Successful Quality Metrics
No supply interruptions
No rejected batches
Decrease/limit
FARs
Recalls
OOS Investigations
Decreased deviation investigations

20. Don’t let this happen to your quality safety net

21. Questions & Discussion.
Thank you.
Questions & Discussion.