UNPA Seminar: GMP V: Inspections, Enforcement, Compliance in 2010 and Beyond

SEMINAR PROGRAM / DAY ONE / THURSDAY, FEBRUARY 11, 2010
Time

8:15 am
REGISTRATION

9:00 am

Introduction of Faculty
by Loren Israelsen, United Natural Products Alliance (UNPA)

• Carl C. Reynolds, Senior Advisor, Division of Dietary Supplement Programs,
Center for Food Safety and Applied Nutrition, U.S. Food & Drug Administration
• Bradford W. Williams, Manager, Division of Dietary Supplement Programs,
Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety
and Applied Nutrition, U.S. Food & Drug Administration
• Dr. Ikhlas Khan, Director of the FDA Center of Excellence, Research Professor,
as well as Professor in the Department of Pharmacognosy at the National Center
for Natural Products Research at the University of Mississippi


9:30 am
I. Historical Perspectives and Current Status
• Review of Dietary Supplement GMP Regulations and Implementation
• Other Regulatory Authorities for Dietary Supplements, Beverages and Foods

10:00 am

II. Who • What • Where • When • Why
• Subpart A – General Provisions / Definitions Exercise
• Subpart B – Personnel
• Subpart C – Physical Plant and Grounds
• Subpart D – Equipment and Utensils


11:00 am
BREAK

11:15 am

III. Production and Process Controls
• Subpart E – Production and Process Control System
• Subpart F – Quality Control
• Subpart G – Components, Packaging and Labeling


12:30 pm
LUNCH

1:30 pm
Review of Section III 483’s
by Loren Israelsen, United Natural Products Alliance (UNPA)
• What are the “Hot Spots?”
• What are Inspectors Looking for?

3:15 pm
BREAK

3:30 pm
• Botanical Authentication and Common Adulterants
• Certificates of Analysis and Vendor Qualification
• Analysis of Adulterants in Supplements: What’s Working? What’s Cost Effective?

4:45 pm
Review/Questions

5:00 pm
Reception for Faculty and Attendees

SEMINAR PROGRAM / DAY TWO / FRIDAY, FEBRUARY 12, 2010
Time

9:00 am
Congressional Update
by Congressman Jim Matheson, Utah’s 2nd District
(congressional schedule permitting)

9:20 am
Overview of Day 1
by Loren Israelsen, United Natural Products Alliance (UNPA)

9:30 am

• Subpart H – Master Manufacturing Record
• Subpart I – Batch Production Record
• Subpart J – Laboratory Operations
• Subpart K – Manufacturing Operations
• Subpart L – Packaging and Labeling Operations


11:00 am
BREAK

11:15 am

• Subpart M – Holding and Distribution
• Subpart N – Returned Dietary Supplements
• Subpart O – Product Complaints
• Subpart P – Recordkeeping


12:30pm
LUNCH

1:30 pm
Q & A with All Faculty

3:30 pm
BREAK

3:45 pm
Other Key Issues Affecting GMP Planning
by Loren Israelsen, United Natural Products Alliance (UNPA)
• Adverse Event Reporting
• Recalls
• Traceability

4:45 pm
Review of Key Learnings and Adjournment


Click here
to download the registration form.

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