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Office of Regulatory AffairsCompliance References:Program Guidance Manual

Compliance Refs TOC

Compliance Program Manual (CPGM)

Policy Guides (CPGs)

Regulatory Procs Manual

Application Integrity Policy

Bioresearch Monitoring Program

Data and Information Integrity

Electronic Records; Electronic Signatures, 21 CFR Part 11

FDA Debarment List

Federal Register Notices

Disqualified /Restricted/ Assurance List for Clinical Investigators

Public Health Service (PHS) Administrative Actions Listings

Compliance Program Guidance Manual for FDA Staff

Compliance programs currently available in electronic form on the FDA website.

Introduction

Biologics (Chapters 42 - 45)

BIMO: Bioresearch Monitoring (Chapter 48)

Drugs (Chapters 53 - 56)

Devices/Radiological Health (Chapters 81 - 86)

Biologics

CPGM (HTML)

Compliance Program Description

Formats Available

7342.006

Inspections of Plasma Derivatives of Human Origin

PDF version

7342.008

Inspections of Licensed Viral Marker Test Kits

PDF version

7345.001

Inspections of Licensed Allergenic Products

PDF version

BIMO: Bioresearch Monitoring

7348.808,

Good Laboratory Practice (Non-Clinical Laboratories)

PDF version 3.22mb

7348.810,

Sponsors, Contract Research Organizations and Monitors

PDF version 1.84mb

7348.811,

Clinical Investigators

PDF version 3.24mb

Drugs

7353.001,

Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations

PDF n/a

7356.002,

7356-002-Draft: Drug Manufacturing Inspections (Pilot Program)

Draft Revision to be used by 6 Pilot Districts only (Philadelphia, Los Angeles, New Jersey, New York, San , and Dallas). For DOMESTIC INSPECTIONS ONLY.

PDF n/a MS Word 145 KB

Devices/Radiological Health

CPGM 7382_845

Inspections of Medical Device Manufacturers

Read online in Web Format Description

cover_page

part1

part2 part3

part4

part5

part6

xref_Index

oc_organization_chart (readable but format lost)

Download MS Word Format Size Description

54784 cover_page.doc

37376 part1.doc

49664 part2.doc

84480 part3.doc

35840 part4.doc

73728 part5.doc

85504 part6.doc

63488 xref_Index.doc

27136 ocorgan.doc

Download PDF Format Size Description

327KB 7382_845.pdf

CPGM 7382_845 Attachments

Read online in Web Format Description

Att_A.htm

Att_B.htm

Att_B-1.htm

Att_C.htm

Att_D.pdf ->

Att_E.htm

Att_F.htm

Att_G.htm

Download MS Word Format Size Description

63488 Att_A.doc

76288 Att_B.doc

29184 Att_B-1.doc

45568 Att_C.doc

9620 7382_845_Att_D.pdf ->

59904 Att_E.doc

41472 Att_F.doc

32256 Att_G.doc

Download PDF Format Size Description

9620 Att_D.pdf

7386_003 (HTML not available)

Field Compliance Testing of Diagnostic (Medical) X-ray Equipment Compliance Program

PDF version 76KB

MS Word 143KB

CPGM 7386_003 Attachments

Attachments A-C Attachment D Attachment E Attachment F Attachment G Attachments H-K Attachment L Attachment M

PDF

A-C D E F G H-K L M

MS Word

A-C D E F G H-K L M

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