General Session Wrap Up

1
General Session Wrap Up

• Hosted by David Arvelo
• FDA ORA SWR
• Small Business Representative

2
SBR Objective

• Assist industry and entrepreneurs
• Facilitate access to guidance, policies,
  regulations and laws enforced by FDA
• Provide technical assistance
• Act as liaison

3
SBR Services

• Answers to inquiries
• Over 1000 per year
• Training opportunities
• Workshops and presentations
• Onsite visits
• Non-regulatory
• Cursory, brief
• As resources permit

4
Confidentiality

• Prohibited by law from divulging proprietary or
  confidential information
• Will not discuss your requests with inspectors
  unless life threatening

5
SBR Limitations

• Cannot intervene when a current investigation
  reveals violative conditions that warrant
  regulatory action
• 483 observations
• Warning letters
• Import detention

6
Southwest Region

• Arkansas
• Colorado
• Iowa
• Kansas
• Missouri
• Nebraska
• New Mexico
• Oklahoma
• Texas
• Utah
• Wyoming
• US-Mexico Border (imports)

7
Contact Information

• David ArveloFDA Southwest Regional Office4040
  N. Central Expressway, Suite 900Dallas, TX 75204
• 214-253-4952
• Fax [phone]
• Email David.Arvelo_at_fda.gov

8
Synopsis Of Lessons Learned

• Session 1 Product Acceptance (including
  statistical techniques and purchasing controls)
• Session 2 Device History Records
• Session 3 Software Validation

9
QA Panel

• Margy Annes
• Dr. Stan Bauman
• Cheryl Boyce
• Michael Chappell
• Bruce Horowitz
• Scott Nichols
• Krista Oakes
• Dan Olivier
• Cindy Walters
• Monica Wilkins
• Norman Wong

10
Thank You!

• Please remember to complete and submit your
• Evaluation form
• CEU form (optional)
• For additional copies of handout materials,
  please submit an FOI request to Food and Drug
  Administration, Office of Management Programs,
  Division of Freedom of Information (HFI-35), 5600
  Fishers Lane, Rockville, MD 20857 or fax (301)
  443-1726