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All documents as shown here are included in the package, and many more!

 

 

 

 

A total of 21 SOPs are included in the package. 15 of them are shown here.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA/EU Compliance of Analytical Laboratories

 

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

  • CD/Binder
  • Web Download

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

  1. A one hour audio presentation with Q&As: FDA/EU Compliance in Analytical Laboratories
    (Train yourself and others on regulations and industry practices)
  2. Primer: FDA/EU Compliance in Analytical Laboratories
  3. Laboratory Compliance Master Plan
  4. Compliance in Analytical Laboratory - Step by Step Implementation
  5. Training Primer: Training for FDA Compliance
  6. 4 Gap Analyses/Checklists: OOS, Laboratory computer systems, Laboratory audits, GLP
  7. 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
  8. 5 Templates and examples: URS for Chromatographic Data Systems, URS for Excel applications, 20 Good/Bad Examples for URS, Test Protocol For Excelâ„¢ Spreadsheet Application, Computer System Identification
  9. 16 reference papers: Equipment qualification, Part 11 in laboratories, OOS, CAPA, data migration, method validation
  10. 30+ most frequently asked question and answers related to laboratory compliance.
  11. 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 $
    699.-
    - 2) Web download for $
    649.-
    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

  1. Corrective and Preventive Actions (s-114)
  2. Handling Out-of-Specification Results (s-115)
  3. Handling Out-of-Trend Situations (s-116) NEW
  4.  21 CFR Part 11 - Scope and Controls (s-137)
  5.  Recording of GLP Raw Data (s-149) NEW
  6. Qualification of Equipment (e-240)
  7. Validation of Spreadsheet Applications (e-264)
  8. Validation of Electronic Laboratory Notebooks (e-267)
  9. Using Electronic Laboratory Notebooks in an FDA Regulated Environment (e-268)
  10. Validation of Electronic Document Management Systems (e-270)
  11. Retention and Archiving of Electronic Records (e-315)
  12. Scanning of Paper Records for GxP Compliant Archiving (e-316)
  13. Generation and Maintenance of SOPs for Laboratories (S-504) NEW
  14. Change control of analytical equipment (s-509)
  15. Conducting Laboratory Management Review (s-510) NEW
  16. Auditing Analytical Laboratories (s-511) NEW
  17. Review and Approval of Analytical Test Results (s-512) NEW
  18. Training for Laboratory Personnel (e-513)
  19. Purchasing and Receipt of Supplies for Laboratories (s-514) NEW
  20. Quality Assessment of Laboratory Suppliers (s-515) NEW
  21. Auditing Suppliers of Laboratory Supplies (s-516) NEW
  22. Risk Assessment for Laboratory Systems (e-519)
  23. Laboratory Complaint Handling (s-520) NEW
  24. Subcontracting of Testing and Calibration (s-522) NEW
  25. Identification and Control of Laboratory Records (s-526) NEW
  26. Laboratory Failure Investigations (e-530)
  27. Sampling for Analytical Testing (s-531) NEW
  28. Preparation of Laboratory Working Standards (s-532) NEW
  29. Handling of Laboratory Test Samples (s-534) NEW
  30. Reserve Samples in Laboratories (s-535) NEW
  31. Measurement Traceability in Chemical Analysis (s-537) NEW
  32. Maintenance of Laboratory Equipment (s-541) NEW
  33. Bioanalytical Method Validation (s-610) NEW
  34. Validation of Analytical Methods (s-612) NEW
  35. Validation of Chromatographic Methods (s-613)
  36. Transfer of Analytical Methods (s-614) NEW
  37. Handling (Certified) Reference Material (s-625) NEW
  38. Development of User Requirement Specifications for Analytical Equipment (e-628)
  39. Allocating Analytical Instrument to USP <1058> Categories (s-629) NEW
  40. Procedures and Deliverables for Qualification of USP <1058> Instrument Categories (s-630) NEW
  41. Development and Maintenance of Test Scripts for Analytical Equipment (e-635)
  42. Calibration of Analytical Balances (s-641)
  43. Qualification of Refrigerators (s-644)
  44. Validation of Laboratory Computer Systems (s-656)
  45. Risk Based Validation of Laboratory Computer Systems (s-662)
  46. 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:

  1. Check list – Out of Specification Situations (OOS)
  2. Gap Analysis/Checklist: Laboratory Computer Systems
  3. Gap Analysis/Checklist: Good Laboratory Practice Regulations
  4. 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

  1. Requirement Specifications For Chromatographic Data Systems
  2. Requirement Specifications For Excel Applications
  3. User Requirement Specifications - 20 Good/Bad Examples
  4. Template/Examples: Test Protocol For Excelâ„¢ 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
  5. 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

  1. Laboratory Compliance Project Team (k-1511) NEW
  2. Sample collection form (k-1611) NEW
  3. Sample receipt form (k-1612) NEW
  4. Summary of Stability Indicating Method Validation (k-1651) NEW
  5. Corrective Action Form (k-3511) NEW
  6. Preventive Action Form (k-3512) NEW
  7. 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

  1. Preventing Out-of-Specification (OOS) Situations Caused by Laboratory Errors
  2. CAPA – A Fundamental Quality Subsystem
  3. Definitions: Qualification vs. Verification, Calibration and Validation
  4. Implementing 21CFR Part 11 in Laboratories
  5. 21 CFR Part 11 Compliance for Pharmaceutical Laboratories: A supplier's perspective
  6. Implementing 21CFR Part 11: Data Migration and Long Term Archiving for Ready Retrieval
  7. Equipment Qualification in Practice
  8. Selecting Parameters and Limits for Equipment Operational Qualification
  9. Qualification of Equipment and Computerized Systems
  10. Risk-Based Validation of Commercial Off-the-Shelf Computer Systems
  11. (Laboratory) Equipment Qualification and Computer System Validation
  12. Qualification of High-Performance Liquid Chromatography Systems
  13. Validation of Analytical Methods: Review and Strategy
  14. Validation of HPLC Methods
  15. Evaluation and Validation of Standard Methods
  16. 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. 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

Picture of Ludwig Huber

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