FDA/EU Compliance in Analytical Laboratories
Requirements and Tools for
Implementation
With audio seminar, 46 SOPs and
free on-line updates
Version 2 just introduced
Now with two Options for Ordering
Intro
Training tools, strategies for compliance and
tools for implementation
Analytical laboratories are considered high
risk systems. Typically they perform the last control step before
products are released or data are submitted to the FDA. Therefore
laboratory systems are on the radar screen of FDA and other
inspections. According to the FDA inspection results 2004/05 the
number of deviations found in laboratory systems come right after
the quality system.
This package helps you to
- Get a good understanding on FDA and
industry requirements
- Develop a strategy and master plans
- Implement the strategies with 40+
reference materials such as SOPs, checklists, templates
Version 2.0 just
released
New or updated
features/documents in version 2 include
- 25 new SOPs
- Updated compliance master plan
- Updated Step-by-Step Implementation Plan
- Updated Primer on Laboratory Compliance
- Training Primer: Training for FDA
Compliance
- 7 New Forms
- New On-line Question/Answer Section
- New Audio Seminar
Package Overview
- A one hour audio presentation with Q&As:
FDA/EU Compliance in Analytical Laboratories
(Train yourself and others on regulations and industry
practices)
- Primer: FDA/EU Compliance in Analytical
Laboratories
- Laboratory Compliance Master Plan
- Compliance in Analytical Laboratory -
Step by Step Implementation
- Training Primer: Training for FDA
Compliance
- 4 Gap Analyses/Checklists: OOS,
Laboratory computer systems, Laboratory audits, GLP
- 46 SOPs for equipment qualification,
training, change control, risk assessment, test scripts,
laboratory computer validation, auditing ´laboratories,
retention and archiving of electronic records, qualification of
balances, method validation
- 5 Templates and examples: URS for
Chromatographic Data Systems, URS for Excel applications, 20
Good/Bad Examples for URS, Test Protocol For Excel™ Spreadsheet
Application, Computer System Identification
- 16 reference papers: Equipment
qualification, Part 11 in laboratories, OOS, CAPA, data
migration, method validation
- 30+ most frequently asked question and
answers related to laboratory compliance.
- 50+ FDA and other regulations and
guidelines with impact on laboratories
- Two years free on-line updates
Target Audience
- Lab managers and personnel
- Analytical scientists
- QA managers and personnel
- IT/IS managers and personnel
- Validation specialists
- Metrology groups
- Training departments
- Documentation departments
- Consultants
- Teachers
Format/Price/Ordering
- Format and Pricing
- 1) Binder with CD, for $599.-
- 2) Web download for $549.-
Prices include shipping and two years on-line updates
VAT will be added for EU countries.
- Size: More than 1000 pages, when printed
- Availability: Worldwide, shipment within
one working day after order entry and payment has been received
- 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 regulatory requirements
Laboratory compliance is quite dynamic. What
was enough yesterday is not enough any more today and what was
necessary last year may not be any more next year.
A book can give the background, the
fundamentals and an overview on regulations and inspection practices
at a particular point in time - but updates reflecting on-going
changes are practically limited to a 3 to 5 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 start up package for the fundamentals
and procedures and the Internet for the updates. That's why the
author offers two year free on-line updates with the purchase of the
Laboratory Compliance package.
Updates include:
- New regulations related to laboratory
compliance and validation
- New guidelines from agencies and industry
task forces
- Interpretations what the new
regulations/guidance mean for laboratories and how to respond
- New SOPs, checklists and examples,
related to laboratory compliance, if necessary
Registration is automatically with each
package purchase from Labcompliance
Support for Compliance
With support for new laws and regulations
Federal laws and regulations mandate to put
controls and measures on laboratories to ensure accuracy,
consistency and integrity of analytical results. Examples are Good
Laboratory Practices, Good Manufacturing Practices , Good Clinical
Practices and 21 CFR Part 11 regulations and Guidelines. This
Laboratory Compliance Package will help to comply with regulations
and still meet business requirements.
Topics related to compliance:
- Checklist: using laboratory computer
systems in FDA regulated environments
- Part 11 checklist, also useful for other
regulations
- Procedure: Risk Assessment for Laboratory
Systems Used in GxP Environments, also useful for other
regulations
- Procedure: Risk Based Validation of
Laboratory Systems
- Procedures to handle failure
investigations, out of specification results and corrective and
preventive action plans
- Procedures to validate analytical methods
in preparation for FDA submissions
- More than 50 regulations and guidelines
with impact on laboratories
All in One
All in one - makes your work efficient and
keeps your budget under control
To implement and maintain compliance in
analytical laboratories can be a complex task. This gets even more
complex and even confusing when information is obtained from
different sources. Frequently they give a high level overview
talking about generic compliance but none gives a full picture and
details that are required for quick implementation.
This package is a single source covering all
aspects. It is written by a single author who has more than 10 years
practical international experience and understands FDA and
international compliance from ground.
The author has been
ranked as number one presenter at various international conferences
and the package answers all questions typically raised at these
conferences:
- What do FDA and other regulations require
for analytical laboratories?
- What exactly are the most frequently
found inspection deviations and how to avoid them?
- How to develop an efficient compliance
program for laboratories?
- How can risk assessment help to comply in
a more efficient manner?
- How to develop a training plan for
laboratories?
- Which written procedures are required and
how to write them?
- How to validate analytical methods?
- How to validate computer systems in
laboratories?
- How to validate Excel spreadsheets
- How to qualify the laboratory network
- How to handle failure investigations and
out-of-specification results?
- How to set up a corrective and preventive
action program
- Which data should be recorded, for how
long and in which form?
Why to go through the hassle and read several
books with lots of redundant information. With this validation
package, you get all answers in one. This not only saves time, it's
also cost effective. And as requirements change, you get the answers
through the on-line update service.
Detailed Contents
1. Primer: FDA/EU Compliance in Analytical
Laboratories
This gives an overview on regulatory
requirements. It discusses and gives recommendations for developing
a compliance program for laboratories. This includes training of
employees, development and enforcement of procedures, validation of
equipment, methods and computer systems and development an
corrective and preventive action plan. It also includes setting up
and internal audit program.
2. Audio Seminar: FDA/EU Compliance in
Analytical Laboratories
In a one our seminar Dr. Ludwig Huber gives an
overview on the regulation and he guides the audience through a
logical step-by-step process on how to make analytical laboratories
compliant in a most cost-effective way.
3. Step-by-Step Implementation
This document guides owners of laboratory
compliance and validation projects through the complete process from
planning to design and implementation and maintaining on-going
compliance.
4. Laboratory Compliance Master Plan
A master plan is the first and most important
compliance document. It improves efficiency and ensures consistent
implementation within a company. It is also an ideal document to
document and demonstrate a company's approach for compliance.
5. Primer: Successful Compliance Training
Training or other means of people
qualification is crucial for laboratory compliance. This primer is
ideally suited to develop a laboratories training program.
6. Risk Management Master Plan
Risk management is important for laboratories
to optimize resources. Inspectors also expect validation activities
to be based on 'justified and documented' risk assessment. This risk
management master plan helps assess risks of laboratory systems and
define validation steps for risk categories.
7. Standard Operating Procedures (SOPs)
In FDA regulated environments routine
operations should follow written procedures. They help to implement
processes and and technical controls in a consistent manner. The
Laboratory Compliance Quality Package includes several example SOPs
- Corrective and Preventive Actions (s-114)
- Handling Out-of-Specification Results (s-115)
- Handling Out-of-Trend Situations (s-116)
NEW
- 21 CFR Part 11 - Scope and Controls (s-137)
- Recording of GLP Raw Data (s-149)
NEW
- Qualification of Equipment (e-240)
- Validation of Spreadsheet Applications (e-264)
- Validation of Electronic Laboratory Notebooks
(e-267)
- Using Electronic Laboratory Notebooks in an FDA
Regulated Environment (e-268)
- Validation of Electronic Document Management
Systems (e-270)
- Retention and Archiving of Electronic Records
(e-315)
- Scanning of Paper Records for GxP Compliant
Archiving (e-316)
- Generation and Maintenance of SOPs for
Laboratories (S-504) NEW
- Change control of analytical equipment (s-509)
- Conducting Laboratory Management Review (s-510)
NEW
- Auditing Analytical Laboratories (s-511)
NEW
- Review and Approval of Analytical Test Results
(s-512) NEW
- Training for Laboratory Personnel (e-513)
- Purchasing and Receipt of Supplies for
Laboratories (s-514) NEW
- Quality Assessment of Laboratory Suppliers
(s-515) NEW
- Auditing Suppliers of Laboratory Supplies (s-516)
NEW
- Risk Assessment for Laboratory Systems (e-519)
- Laboratory Complaint Handling (s-520)
NEW
- Subcontracting of Testing and Calibration (s-522)
NEW
- Identification and Control of Laboratory Records
(s-526) NEW
- Laboratory Failure Investigations (e-530)
- Sampling for Analytical Testing (s-531)
NEW
- Preparation of Laboratory
Working Standards (s-532) NEW
- Handling of Laboratory Test Samples (s-534)
NEW
- Reserve Samples in Laboratories (s-535)
NEW
- Measurement Traceability in Chemical Analysis
(s-537) NEW
- Maintenance of Laboratory Equipment (s-541)
NEW
- Bioanalytical Method Validation (s-610)
NEW
- Validation of Analytical Methods (s-612)
NEW
- Validation of Chromatographic Methods (s-613)
- Transfer of Analytical Methods (s-614)
NEW
- Handling (Certified) Reference Material (s-625)
NEW
- Development of User Requirement Specifications
for Analytical Equipment (e-628)
- Allocating Analytical Instrument to USP <1058>
Categories (s-629) NEW
- Procedures and Deliverables for Qualification of
USP <1058> Instrument Categories (s-630) NEW
- Development and Maintenance of Test Scripts for
Analytical Equipment (e-635)
- Calibration of Analytical Balances (s-641)
- Qualification of Refrigerators (s-644)
- Validation of Laboratory Computer Systems (s-656)
- Risk Based Validation of Laboratory Computer
Systems (s-662)
- Reporting Analytical Data for FDA and ISO 17025
Compliance (s-672) NEW
8. Gap Analysis/Check List/Worksheets
Gap analyses and checklists are key to
identify missing procedures and technical controls to for laboratory
compliance. The Package includes gap analyses and worksheets as
follows:
- Check list – Out of Specification
Situations (OOS)
- Gap Analysis/Checklist: Laboratory
Computer Systems
- Gap Analysis/Checklist: Good Laboratory
Practice Regulations
- Worksheet: Laboratory Audit
9. Templates and Examples
Templates and examples help implement the
Laboratory compliance processes effectively and consistently
throughout your organization. The Package includes
templates/examples for
- Requirement Specifications For
Chromatographic Data Systems
- Requirement Specifications For Excel
Applications
- User Requirement Specifications - 20
Good/Bad Examples
- Template/Examples: Test Protocol For
Excel™ Spreadsheet Application
(with traceability matrix): Includes
12 test scripts examples for functional testing, includes
boundary testing, out of range testing, test traceability
matrices: tests vs. specifications, specifications vs. test
cases, test summary sheet
- Template/Examples: Computer System
Identification
10. Forms
Forms help implement the Laboratory compliance
processes effectively and consistently throughout your organization.
The Package includes forms for
- Laboratory Compliance Project Team
(k-1511) NEW
- Sample collection form (k-1611)
NEW
- Sample receipt form (k-1612)
NEW
- Summary of Stability Indicating Method
Validation (k-1651) NEW
- Corrective Action Form (k-3511)
NEW
- Preventive Action Form (k-3512)
NEW
- Recording Sampling Data (k-3519)
NEW
11. Reference Papers
Reference papers help to get an in depth
understanding on selected topics. The Package includes reference
papers for
- Preventing Out-of-Specification (OOS)
Situations Caused by Laboratory Errors
- CAPA – A Fundamental Quality Subsystem
- Definitions: Qualification vs.
Verification, Calibration and Validation
- Implementing 21CFR Part 11 in
Laboratories
- 21 CFR Part 11 Compliance for
Pharmaceutical Laboratories: A supplier's perspective
- Implementing 21CFR Part 11: Data
Migration and Long Term Archiving for Ready Retrieval
- Equipment Qualification in Practice
- Selecting Parameters and Limits for
Equipment Operational Qualification
- Qualification of Equipment and
Computerized Systems
- Risk-Based Validation of Commercial
Off-the-Shelf Computer Systems
- (Laboratory) Equipment Qualification and
Computer System Validation
- Qualification of High-Performance Liquid
Chromatography Systems
- Validation of Analytical Methods: Review
and Strategy
- Validation of HPLC Methods
- Evaluation and Validation of Standard
Methods
- Preparation and Qualification of
Certified Reference Material and Working Standards
12. 30+ Most Frequently Asked Questions and
Answers
This section includes more than 30 questions
and answers on compliance issues in laboratories. The questions have
been received during our audio seminars, conference workshops and
through e-mail.
13. FDA Regulations and Guidelines
The package includes includes most important
guidelines with impact on Laboratories published by the FDA, the EU
and Japan.
14. On-line Update Support
Subscribers of the package get two years
on-line updates through a password protected website. This includes
regulatory updates and other new documents such as SOPs, examples
and templates.
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