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

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