Validation and Qualification in Analytical Laboratories
- Video Training and Best Practice Guides -

Helps to quickly understand and implement analytical instrument qualification and validation of methods and computer&software

 

 

Version 2 just introduced 

Now with two Options for Ordering

• CD
• Web Download

Intro

CD includes

1. An interactive video on CD or as web download with 39 clips: convenient and efficient multimedia training from your desk or in a team
   Title: Validation and Qualification in Analytical Laboratories (presenter: Dr. Ludwig Huber)
2. 18 useful documents for easy and convenient implementation: SOPs/Templates/Examples/Gap Analyses/Checklists .
3. 50+ FDA Regulations and guidelines related to GxP, equipment qualification, method validation and 21 CFR Part 11, e.g., more than 20 predicate rules: help to understand FDA regulations and FDA's current thinking. Includes 14 guidelines specific to analytical laboratories.
4. 20 FDA Warning Letters/Establishment Inspection Reports (EIR) and/or 483 inspectional observations related to laboratory procedures and equipment - with keywords for easy searching. Learn from and avoid mistakes others made.
5. Documents from agencies in Europe related to equipment qualification.

CD with Interactive Video Training, SOPs, Worksheets and Reference Material

The validation reference text book Validation and Qualification in Analytical Laboratories is ideal to get detailed information on why, what and how to validate computer systems in laboratories. Books are very convenient for longer reading of detailed information. However, to get a quick and convenient overview intuitive multimedia training tools are preferred. Such electronic tools have also the advantage that they have enough space to hold back-up and reference material. That's the reason why we have developed this CD ROM as as complementary tool to the text book. It is an ideal training tool and has all the working tools and reference material that is required to quickly implement and back-up your validation work.

Detailed Contents

1. Interactive Video presentation

• 39 Video clips on CD
• On MS Powerpoint, comes with Powerpoint Viewer
• Contents
  - Regulatory requirements, inspection findings
  - Validation overview and approach
  - Developing a validation master plan
  - Equipment qualification: DQ/IQ/OQ/PQ
  - Validation of computerized systems&spreadsheets
  - Qualification of existing systems
  - Validation
  - Qualification of (certified) reference material
  - Laboratory audits

2. 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.

 

3. 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.

 

4. 9+ Standard Operating Procedures - Save days and weeks!

1. Qualifiaction of Equipment (s-240)
2. Generation and Maintenance of SOPs for Laboratories (S-504)
3. Change control of analytical equipment (s-509)
4. Training for Laboratory Personnel (e-513)
5. Risk Assessment for Laboratory Systems (e-519)
6. Laboratory Failure Investigations (e-530)
7. Validation of Chromatographic Methods (s-613)
8. Handling (Certified) Reference Material (s-625)
9. Development of User Requirement Specifications for Analytical Equipment (e-628)
10. Calibration of Analytical Balances (s-641)
11. Qualification of Refrigerators (s-644)

5. Five Gap Analyses/Checklists/Worksheets - For complete implementation - just not to forget anything!

1. Out of Specification Situations (OOS) (E-116)
2. Laboratory Computer System (E-158)
3.  Good Laboratory Practice Regulations (E-166)
4. Laboratory Audit (E-184)
5. 21 CFR Part 11

6. Four Templates and Examples - For effective and consistent implementation - take the easy way!

• Equipment hardware identification
• Equipment hardware master list
• Inventory of Excel spreadsheets
• User Requirement specifications of chromatographic data systems

7. 15 Reference Papers useful as background information

• Preventing Out-of-Specification (OOS) Situations Caused by Laboratory Errors (A-122)
• CAPA – A Fundamental Quality Subsystem (A-123)
• Definitions: Qualification vs. Verification, Calibration and Validation (A-154)
• 21 CFR Part 11 Compliance for Pharmaceutical Laboratories: A supplier's perspective (A-188)
• Implementing 21CFR Part 11: Data Migration and Long Term Archiving for Ready Retrieval (A-194)
• Equipment Qualification in Practice (A-234)
• Selecting Parameters and Limits for Equipment Operational Qualification (A-239)
• Qualification of Equipment and Computerized Systems (A-264)
• Risk-Based Validation of Commercial Off-the-Shelf Computer Systems (A-273)
• (Laboratory) Equipment Qualification and Computer System Validation (A-552)
• Qualification of High-Performance Liquid Chromatography Systems (A-553)
• Validation of Analytical Methods: Review and Strategy (A-603)
• Validation of HPLC Methods (A-605)
• Evaluation and Validation of Standard Methods (A-607)
• Preparation and Qualification of Certified Reference Material and Working Standards (A-663)

8. Twenty+ FDA 'Predicate Rules', for example,

• Good Laboratory Practice (GLP)
• Current Good Manufacturing Practice
• Good Clinical Practices (GCP)
• Animal drugs
• Medical device
• Quality systems
• Food
• Electronic records and signatures (part 11) with preamble

9. Twenty+ FDA Guidelines Related to Laboratories, for example,

• Mass spectrometry for the confirmation of the identity of animal drug residues
• Inspections of pharmaceutical Quality Control laboratories
• Inspections of microbiological pharmaceutical Quality Control laboratories
• Analytical procedures and method validation
• Requesting methods validation for abbreviated new drug applications
• Bioanalytical methods validation
• Investigating out of Specifications test results
• Drug Substance - Chemistry, Manufacturing, and Controls Information
• Guidance on the review of analytical data generated by private laboratories
• Investigational training manual related to inspection of computer systems
• Current and withdrawn part 11 guidances
• Questions/Answers on GLP (28 pages)
• Submitting samples and analytical data for methods validation
• ICH-Q2A-Validation of Analytical Procedures: Definitions and Terminology
• ICH-Q2B-Validation of Analytical Procedures: Methodology

10. FDA Warning Letters, Establishment Inspection Reports (EIR) and/or 483 inspectional observations

• Related to laboratory equipment testing, method validation, people qualification, handling out of specification situations, corrective and preventive actions
• Reflect FDA's 'thinking' about details
• Useful in preparation for audits
• Help to avoid inspectional observations and warning letters

11. Documents from Europe related to computer validation, for example,

• Annex 11 of EU GMP directive, includes 19 requirements for computer systems
• Annex 15 of EU GMP directive on "Validation and Qualification"

Target Audience

• Lab managers and personnel
• QA managers and personnel
• Analytical scientists
• Validation specialists
• Metrology departments
• Documentation departments
• IT Departments
• Consultants
• Teachers

Format/Price/Ordering

• Format and Pricing
  - 1) CD for $299.-
  - 2) Web download for $259.-
  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

 

Bundle: Book plus CD - 12% savings

 

1. Includes the book: Validation and Qualification in Analytical Laboratory
   Handy Validation Reference for your entire laboratory
2. CD: Validation and Qualification in Analytical Laboratories
   - Interactive video for quick introduction and overview
   - SOPs, examples, checklists for easy implementation
   - Regulations, guidelines as reference material
3. On-line update for 2 years
   - Keeps you up-to-date with ever changing FDA expectations

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

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