FDA GMP Inspections CONTENT Package

This package contains 8 content elements in preparing for and successfully executing FDA inspections related to CAPA, change control and Part 11 (Electronic Records and Signatures and includes: 3 webinar recordings, 3 PowerPoint training presentations (90+ slides), 2 reference articles (21 pages):

➢ 1. and 2. Change Control Hot Topics: FDA/Global Regulatory Inspections (One Hour Webinar Recording and PDF PowerPoint Training Presentation)

➢ 3.and 4. FDA CAPA Inspections: A Primer for Successful Execution (One Hour Webinar Recording and PDF PowerPoint Training Presentation)

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➢ 5. and 6. FDA Part 11 Inspections: A Primer for Successful Execution (One Hour Webinar Recording and PDF PowerPoint Training Presentation)

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➢ 7. FDA For Cause Inspection - A Compliance Narrative From a Fictional Drug Company: Part I

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➢ 8. FDA For Cause Inspection - A Compliance Narrative From a Fictional Drug Company: Part II

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1. and 2. Change Control Hot Topics: FDA/Global Regulatory Inspections (One Hour Webinar Recording and PDF PowerPoint Training Presentation)

➢FDA requirements for a change control program - Drug products, Medical devices, Active Pharmaceutical Ingredients (APIs)

➢“Hot topics” from the FDA (including specific examples from Warning Letters, 483’s, and other sources from 2008 – present) regarding: Documentation of changes, Approval of changes, Rationale for changes,Validation of changes, Use of risk assessment to evaluate changes, Importance of assessing changes both looking forward and looking backward, FDA’s view of “like-for-like” changes, Inclusion of changes in annual product reviews, “Mandatory” changes, Management of computer system changes

➢International regulatory “hot topics” on change control, such as: Why do we need to assess the impact of productivity and capacity changes on quality operations?, When is like-for-like not really like-for-like?

➢Assessing your own change control program: Specifications that can prevent similar issues in your operations – for each Warning Letter or 483 example noted, a specificaction which might have prevented the citation will be discussed, Use of the Change Control Audit Checklist to identify and bridge potential compliance gaps

3. and 4. FDA CAPA Inspections: A Primer for Successful Execution (One Hour Webinar Recording & PDF PowerPoint Training Presentation)

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Webinar instructor William McQuillan, Jr. former Global Manager, Change Document and Records Management, Cordis, a Johnson&Johnson Company, reviews the following subject matter content below:

➢ Preparing for an Inspection

-File preparation

-Staging room setup

➢Managing an FDA Inspection

-CAPA owner preparation

-Information flow

-Time management

➢FDA inspection Areas of Focus:

-CAPA initiation

-CAPA timelines

-CAPA effectiveness

-Appropriate responses during the inspection

➢FDA inspection trends

➢Benefits of compliance to CFR 820 Subpart J

5. and 6. FDA Part 11 Inspections: A Primer for Successful Execution (One Hour Webinar Recording & PDF PowerPoint Training Presentation)

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➢ About 21 CFR Part 11

➢Preparing for an FDA inspection

➢Hosting an inspection

➢Commonly asked questions

➢Appropriate responses

➢Warning letters

➢Target areas

➢Trends

➢Benefits of being compliant

➢Information resources

7. FDA For Cause Inspection - A Compliance Narrative From a Fictional drug Company: Part I

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This two-part 21 page article (written in a narrative format) presents a fictional scenarios where in FDA received a drug complaint and shows up announced at this fictional drug manufacturer one day.This compliance narrative focuses on the interaction between the quality assurance manager and FDA investigator throughout the inspection, and illustrates how one fictional company can find it self in regulatory trouble when it doesn't follow GMP and fails to have specific written quality system procedures. Many are as are discussed, including:

➢ Records Management

➢ Personnel roles and responsibilities

➢ Reviewing product complaints

➢ 211.192 investigations

➢ Product rejections

➢ Validation records

➢ Retesting

➢ Procedures

➢ FDA Closeout meeting

8. FDA For Cause Inspection -A Compliance Narrative From a Fictional drug Company: Part II

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At the conclusion of Part I, the FDA investigator had issued a six-item 483. The QA Manager, Plant Manager, and Regulatory Manager briefly discussed the items on the 483. It was agreed that the three managers would meet and draft a response to each item on the 483, and submit a draft to corporate management for review. This article (written in a narrative format) provides the results of that meeting.

FDA GMP Inspections CONTENT Package is only $99.00 - 

Related Content Package:

Managing FDA GXP Inspctions Content Package - click here