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Clinical Trials Webinar Series - FDA Audits and Inspections: A Manufacturer's Perspective
Clinical Trials Webinar Series - FDA Audits and Inspections: A Manufacturer's Perspective

Clinical Trials Webinar Series - FDA Audits and Inspections: A Manufacturer's Perspective

Release date: 09-21-12
Expiration date: 09-18-15

Author

Steven Zigler, PhD has the following disclosures:
PETNET - Employee
Siemens - Employee

Target Audience
Physicians, pharmacists, and technologists

Objectives
At the completion of this activity, the participant will be able to:

1.  Describe recent experiences with FDA inspections of manufacturing practices for investigational PET drugs.
2.  List the types of FDA inspections.
3.  Specify the mechanics of the FDA inspection process and follow-up.
4.  Discuss the importance of FDA inspections from the perspective of a commercial manufacturer.

Continuing Education Credit Information

AMA-PRA (Physician)
The Society for Nuclear Medicine and Medical Imaging, Inc. (SNMMI) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

SNMMI designates this enduring material for a maximum of 1.0 AMA PRA Category 1 CreditTM. Physicians should claim only credit commensurate with the extent of their participation in the activity. To receive CE credit, learners must achieve a score of 80% on the post-course assessment and complete the evaluation. Release date: 09-21-12 Expiration date: 09-18-15.


   
ACPE (Pharmacists)
The Society for Nuclear Medicine and Molecular Imaging, Inc. (SNMMI) is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. This activity has been designated as knowledge-based CPE. The universal program number for this enduring material is 0210-0000-12-031-L04-P. Total available credit for pharmacists is 1 hour or 0.10 CEUs. Release Date: 09-21-12 Expiration Date: 09-18-15. To receive CE credit, learners must achieve a score of 80% on the post-course assessment and complete the evaluation.

VOICE (Technologists)

The SNMMI, through its Verification of Involvement in Continuing Education (VOICE) program, has approved this journal article for a maximum of .10 continuing education hours (CEHs). VOICE-approved credit is recognized by most licensure states and by the NMTCB and ARRT as Category A credit. In order to receive CE credit, you must first complete the activity content. When completed, take the post-test assessment. You must obtain a score of 80% to receive the CE credit. You will have no more than 3 attempts to successfully complete the post-test. Release Date: 09-21-12 Expiration Date: 09-18-15 California Scope: 1 Imaging(I)/Non-Imaging(NI) / Radiopharmacy(R) / Therapy(T).

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- Apple Safari (version 4 or higher)

Plug-in: Adobe Acrobat Reader (
http://get.adobe.com/reader/)

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Type:     Internet Activity (Enduring Material)
4 Registered Users