FDA Inspections - Preparation, Conduct, Follow-up

Helps to save money and time and to protect your personal and your company's good reputation

With Guidelines on Risk Based System Inspections

 

Version 4 just introduced 

Now with two Options for Ordering

• CD
• Web Download

Intro

An FDA inspection can be a business disaster that costs your company money, time and reputation, or it can be an opportunity to make a long lasting good impression at the FDA and to improve your quality systems.

Single and multiple 483 Inspectional Observations and Warning Letters can be a disaster for a company. Bad reputation for the company and employees, delay of new product approvals, import alters, products recalls, multi-million $ fees, seizures and consent degrees can be the consequence if not followed up correctly in time. However, 483's and warning letters can be avoided.

Version 4.0 just released

• More features
• More documents
• Less trouble

New or updated features/documents in version 4 include

• New 85 pages FDA Inspections Survival Guide - The authentic guide to make FDA inspections successful
• Audio seminar: Six Steps for Successful GMP Inspections: Preparation - Conduct - Follow Up
• New SOP: Responding to FDA 483 Inspectional Observations
• New SOP: Responding to FDA Warning Letters
• New SOP: International GMP Inspections – Preparation, Conduct, Follow up
• New SOP: Internal Audits - Preparation, Conduct, Follow-up
• New SOP: Installation Qualification Protocol for Manufacturing Equipment
• New SOP: Conducting Management Reviews
• New FDA and international guidelines
• Seven FDA Presentations - Learn directly from inspectors and reviewers
• Worksheet/gap Analysis: Quality systems for drug cGMPs
• Worksheet/gap Analysis: Generation and maintenance SOPs
• 100+ new FDA Warning Letters/483s/Inspection Reports

Knowing FDA regulations and guidelines help but are not enough. Knowing what FDA inspectors are looking at and knowing enforcement practices and trends are equally important. And when it happened, damage can be minimized by effective and timely response. This is where this workbook helps: avoid 483's and warning letters and if you get one, respond effectively to minimize damage.

Package includes everything you need for quick start and efficient implementation

• FDA inspections survival guide to get a good understanding on regulations, inspection practices, consequences of deviations and how to respond to warning letters.
• SOPs for risk assessment, people qualification/training and change control.
• SOP for preparation, conduct and follow up of FDA and international inspections.
• SOPs for responding to 483's and warning Letters
• SOPs for generation and maintenance of SOPs and for management reviews
• SOP for internal auditing
• SOPs for qualification of equipment and change control
• Worksheets with gap analyses for GLP, cGMP and 21 CFR Part 11
• Worksheet/checklists for internal audits, an ideal preparation for FDA inspections
• Worksheet/Gap Analysis: FDA Globalization act for more inspections
• Worksheet/Gap Analysis: Quality systems for drug cGMPs
• Worksheet/Gap Analysis: Generation and maintenance SOPs
• Worksheet/Gap Analysis: Validation of commercial Off-the-shelf computer systems
• Worksheet to implement Drug CGMP Quality Systems, a major audit item
• With real examples for FDA 483's, Establishment Inspection Reports (EIR), Product recalls, Consent decrees.
• More than 200 warning letters/483's/EIR's related to Pharma GxPs or medical devices with key word search and instant download
• More than 100 FDA and international  regulations or guidelines.
• Question and Answers with FDA officials about FDA the 'New' inspections.
• Audio seminar - To teach yourself, your operations, IT and QA departments, your managers and others
• Presentation by Chris Nelson – FDA: U.S. FDA Approach for Auditing, including QSIT (38 Powerpoint Slides)
• Convenient browser based user interface .
• Two years on-line updates

Detailed Package Contents

1. Survival Guide to FDA Inspections (85 pages)

• Meaning and importance of laws - regulations - industry guidelines - inspection guides
• Consequences of Non-Compliance
  483s - Warning Letters - EIRs - product recall - seizure - consent degree - import alert - debarment
• FDA's inspection and enforcement practices
• Developing processes and procedures for compliance
• Preparing your organization for FDA inspections
• Science and risk based system inspections - what does this mean
• Going through an FDA inspection
• Effective response to 483's and warning letters
• For more detailed contents click here

2. Example SOPs

• Generation and Maintenance of SOPs (S-104) UPDATE
• Internal Audits - Preparation, Conduct, Follow-up (s-108) NEW
• Conducting Management Reviews (S-111)
• Training for GMP Compliance (S-124)
• Building a GMP System for International Environments (S-126)
• Risk Assessment for Systems Used in GxP Environments (S-134)
• FDA Inspections: Preparation, conduct and follow-up (S-141) UPDATE
• International GMP Inspections – Preparation, Conduct, Follow up (S-142)
• Responding to FDA 483 Inspectional Observations (S-143) NEW
• Responding to FDA Warning Letters (S-144) NEW
• Archiving and Retrieval of GMP Data and Other Documents (S-162)
• Qualification of Equipment (S-240) UPDATE
• Change Control for Software and computer systems (S-262)
• Retention and Archiving of Electronic Records (S-315)
• Review and Approval of Analytical Test Results (S-512)
• Laboratory Failure Investigations (S-530)
• Installation Qualification Protocol for Manufacturing Equipment (S-915)

3. Gap Analysis/Worksheets/Examples

• Drug CGMP Quality Systems (E-110)  UPDATE
• SOP for Healthcare Industry (E-115) UPDATE
• Initial and On-going Training (E-117)
• FDA Record Retention and Retrieval (E-155)
• Commercial Off-the-shelf Computer Systems (E-160)
• Good Laboratory Practice Regulations (E-166)
• (Current) Good Manufacturing Practice Regulations (E-167)
• Electronic Records and Signatures (E-168)
• Laboratory Audits (E-184)
• FDA Globalization Act Activities (E-192) UPDATE
• Example: Performance Qualification Protocol – HVAC System – White Product Lines (E-917)

4. FDA Warning letters, 483-form and EIR inspection reports

• More than 200 FDA Warning letters and/or 483 inspection reports related to GxP and medical devices
• With detailed Establishment Inspection Reports
• With keyword search
• Quarterly updates through the two year online-update service

5. FDA Presentations - Learning from Inspectors and Reviewers

• Insight on FDA Inspections and Recommendations
• The Inspection is Over – What Happens Next? Possible FDA Enforcement Actions
• Writing An Effective 483 Response
• FDA API Inspections
• FDA cGMP Inspections
• FDA Update: Data Integrity and Fraud – Another Looming Crisis?
• Laboratory GMPs and Inspectional Issues: an FDA Perspective

6. Certificate for two years on-line updates through password protected website

• New SOPs, gap analyses, worksheets
• New 483's, trend setting warning letters and Establishment Inspection Reports (EIR)
• Updates on regulations and guidance

7. Audio seminar : Six Steps to Successful GMP Inspections - Preparation, Conduct, Follow-up

• Meaning and importance of laws - regulations - industry guidelines - inspection guides
  Consequences of Non-Compliance
  - 483s - Warning Letters - product recall - seizure - consent degree - import alert - debarment
• FDA's inspection and enforcement practices - Representative examples of Warning Letters and 483's
• Processes and procedures for compliance
• Surviving an FDA inspection
• Effective response to 483's and warning letters
• Impact of FDA's 21st CGMP Initiative on inspections

Target Audience

• Everybody working in corporate management
• Lab/manufacturing/accounting managers and personnel
• Legal departments
• Regulatory affairs
• Production engineers
• Financial analysts
• QC Directors/Qualified Persons
• QA managers and personnel
• Validation groups and specialists
• Consultants
• Teachers

Format/Price/Ordering

• Format and Pricing
  - 1) CD for $499.-
  - 2) Web download for $459.-
• Price: Includes shipping and free on-line update for two years.
• VAT will be added for EU countries.
• Size: More than 500 pages, when printed
• Availability: Worldwide, shipment within one working after
• Ordering: (SSL secured, recommended for payment by credit card)
  - Electronically from this this web site (SSL secured)
  - Regular mail or fax using the form in PDF or MS Word format

Free Online Updates

On-line updates - keeps you on top of ever changing inspection practices

Regulations stay the same for long time. What changes more frequently are guidance documents and inspection and enforcement practices.

A workbook and primer can give the background, the fundamentals and an overview on regulations and inspection practices and tools for implementation at a particular point in time - but updates reflecting on-going changes are practically limited to a 1 to 3 year time frame.

The Internet with it's instant publication power can give this update on a much more frequent basis, but is not so popular to learn the fundamentals. The real solution is a combination of both: get the workbook for the fundamentals and efficient to become compliant at a particular time and the Internet for the updates to maintain compliance. That's why we offer two year on-line updates with the purchase of the package.

Updates are about quarterly and include:

• New regulations and guidelines from agencies
• Updates on new FDA's new initiatives
• Feedback from the industry
• New and updated worksheets, gap analyses
• New and updated SOPs
• Most recent inspection trends
• New 'trend setting' FDA warning letters, EIRs and 483's

Registration is automatically with each package purchase from Labcompliance

Click here to go to the update site (requires access information)

Support for FDA's New Enforcement Practice

The program as it has been anounced by the new commissioner Margaret Hanburg in early August 2009 supports public health protection by facilitating the timely issuance of warning letters. The program establishes a timeframe of 14 days for the submission and agency review of postinspection responses to inspectional observations that are communicated to a firm through issuance of a form FDA 483. The program will begin on September 15, 2009.  The purpose of this program is to optimize resource utilization, facilitate the timely issuance of warning letters, and promote prompt correction of violations.

 

The package helps to comply with the new FDA enforcement practices through:

• Link to a presentation script from the FDA commissioner Hamburg where the program was announced
• Link to an FDA press release  with detail of six program steps
• Link to the the federal register with enforcement details
• SOPs on Responding to FDA 483s and Warning Letters
• Clear description of FDA requirements and Labcompliance recommendations in the new FDA Inspection Survival Guide  

All in one - makes your work efficient and keeps your budget under control

For complex tasks like this you usually need to purchases several books, club memberships or conference tickets.

This workbook is a single source covering all aspects of FDA inspections. It is written by a single author who has more than 10 years practical international industry experience and understands FDA compliance from ground.

The author of the workbook has been ranked as number one presenter at various international conferences. He is IVT's presenter of the year and the #1 author for GMP and Pharmaceutical Quality Assurance topics selected by members of the European Compliance Academy.

He answers questions like:

• What is the meaning and difference between laws, regulations, FDA guidance documents?
• What is an inspection and when will the FDA inspect what?
• What are FDA's actions in case of non-compliance: 483's, EIRs, warning letters, import alerts, product recalls, seizure, consent decrees, debarment?
• Which are actions and programs that should be part of routine operation for FDA compliance
• What is FDA's approach for risk based inspections?
• What mistakes did others make and how can I avoid them?
• How to get prepared for FDA inspections?
• How to get prepared for international inspections?
• The inspection is coming, what to do?
• How to prepare your people for the inspection?
• Which SOPs and other documents do you need?
• What documentation is expected to be in English (for non English speaking countries)
• The inspector arrived and asks all types of questions, what should/must we answer and at what level of detail?
• What is the difference between conventional and science&risk based system inspections?
• What areas does the FDA target during an inspection?
• How to show your quality improvement efforts
• What’s included in each of the six systems the FDA might inspect
• How to address common issues that arise prior, during and after an FDA inspection
• What are the most frequently cited deviations?
• The inspector identifies non-compliance, what can we do during inspection to avoid 483 and warning letter?
• The importance of the exit meeting, can we influence the inspector's mind?
• How to analyze and respond to 483's and warning letters?
• What are frequently found deviations from compliance and how to prevent them?
• Do you have examples for 483's, warning letters, EIR's, company responses?

Why to go through the hassle and read several books, publication and internet sites with lots of redundant information. With this workbook, targeted to FDA regulated environments in the United States and all over the world, you get all answers in one. This not only saves time, it's also cost effective and gives you confidence for inspections. And as regulations, guidelines and inspection practices change, you get recommendations through the on-line update service, for two full years.

The author

The author, Dr. Ludwig Huber, is an international expert on validation and compliance in regulated industries and laboratories. He has been responsible for the compliance program at Hewlett Packard and Agilent Technologies for more than fifteen years. He serves as a consultant for the industry and regulatory agencies on local and international compliance issues. He has been a member of the US PDA task force on 21 CFR Part11 and of the GAMP Special Interest Group for Laboratory Computer Systems.

He is also on the advisory board for the European Compliance Academy and is a member of IVT task force on network qualification. Several of his previous books have been bestsellers and several times he has been ranked as number one presenter at various international conferences. For publications, presentations and other achievements, click here

Dr. Ludwig Huber delivers workshops together with U.S. FDA professionals. Here with FDA's Nick Buhay at a workshop during a joint FDA/Industry training session in China in April 2006.

Detailed contents of the FDA Inspection Survival Guide, chapter by chapter

1. Introduction

2. FDA Regulations and Guidances

• Laws: learn the difference between law and regulations
• Contents and where to find Industry Guidances, Inspection Guidance and Compliance Policy Guidances

3. Sequentional FDA actions in case of non-compliance

• Inspectional observations on 483 forms
• Establishment Inspection Report (EIR)
• Warning letters
• Product recalls
• Seizure
• Consent degree
• Debarment
• Financial and regulatory consequences

4. FDA 483 inspectional Observations and Warning Letters

• Where to find them
• How to use them and what can we learn
• Most frequent citations
• >200 selected examples with full text

5. Prepare your Organization for FDA Compliance

• Common requirements of all FDA regulations
• Without knowing them and their implementation - FDA inspections will fail
• Learn about six systems as defined in FDA's cGMP compliance pilot program
• Learn what procedures are required for all six systems
• Learn how to build a quality system as pre-requisite for successful inspections

6.The FDA Inspection is coming: Make the Best out of it

• Preparing your organization for FDA inspections
• Example for internal audit - the ideal preparation
• Preparing your people
• The inspection is coming
• The inspector has arrived
• Guidance through an inspection
• How to respond to questions?
• The exit meeting?
• Inspection follow up.

7. You got a 483 or a Warning Letter - You can still minimize the damage.
learn how through

• Response during and right after the inspections: Positive example from real Inspection Report
• Analyzing 483's and warning letters
• Contacting the FDA district office
• Form and content of official response to 483's
• Form and content of official responses to warning letters

Appendix A. Glossary

• Describes terms and abbreviations used in the primer

Appendix B. Literature

• Appendix B. Literature references, most references are linked to internet sites or to the CD for immediate view, download and print.

The author

The author, Dr. Ludwig Huber, is an international expert on laboratory compliance and quality standards. He has been responsible for the compliance and quality standards program at Hewlett Packard and Agilent Technologies for more than 20 years. He serves as a consultant for the industry and agencies on local and international compliance and quality issues. He has been a member of the US PDA task force on 21 CFR Part11 and of the GAMP Special Interest Group for Laboratory Computer Systems. He is also was/is on the advisory board for the European Compliance Academy and IVT's GxP Journals. Several of his previous books have been bestsellers and several times he has been ranked as number one presenter at various international conferences. For publications, presentations and other achievements, click here