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Labcompliance Solutions

Compliance solutions help the healthcare industry and laboratories to comply with FDA and other regulations and with quality standards.. We offer a variety of choices ranging from literature like books, articles, SOPs and test scripts to complete compliance packages for selected topics like networks and spreadsheets. We also provide on-line audio-seminars from basics of validation and compliance to most advanced and up-to-date FDA interpretations. All products have been developed by Dr. Ludwig Huber, Chief Advisor for Global FDA Compliance. For information on the author and real client testimonials click here.

Text books and CD's

We offer books and CD's that have been published by Interpharm/CRC and Labcompliance. While books are ideal to get complete back ground information, CD's are provided with interactive videos presentation and with reference material. Books and CD also include access to a website for two years free update information. They are available for qualification and validation in analytical laboratories and Validation of analytical and networked systems.

Books

CDs

Complete Compliance Packages

Provide complete solutions to address critical compliance requirements. They include interactive videos or audio presentations to train yourself and others on the topic, they also include tools like SOPs, gap analyses and examples for easy implementation and lot's of reference material to back up your decisions. Purchasing price also include access to a website for two years free update information.

Examples are

Master plans

Master plans are very useful to document your company's approach towards processes required by regulations. They can be used to develop individual project plans and increase efficiency and consistently in your organization.

Examples are

Online Audio Seminars

They are ideal to get most current and up-to-date information in just one our without traveling costs. Seminars are delivered through interactive telephone presentations and all hand-out material can be downloaded from seminar specific websites. Hand-out includes the Powerpoint presentation, SOPs, checklists, and validation examples. The seminars are recorded so they are are available after afterwards. Key focus is on new regulations, guidance documents and enforcement trends.

Currently we offer more than 200 seminars. For a list of recorded and upcoming seminars click on the link below

Video Seminars

We have converted our most successful audio seminar into Video seminars. Presentations are delivered with video clips embedded in animated Powerpoint slides. Hand-out are the same as for audio seminars and include the Powerpoint presentation, SOPs, checklists, and validation examples. Key focus is on providing basic information and strategies and tools for implementation.

Currently we have six seminars in our offering. For a list of seminars click on the link below

Workshops

Workshops are delivered as classroom trainings. They last one or two days. Labcompliance develops materials and facilitates the workshops. Workshops are offered and organized as in-house training or through seminar or conference providers.

Currently we have six workshops in our offering. For a list of seminars click on the link below

Labcompliance Users Club

Join the Users Club and instantly download more than 500 documents and video clips. More are coming about every month. Documents include SOPs, examples, templates, FDA warning letters, establishment inspection reports and 483 inspectional observations. The Users Club also includes FDA presentations and information bulletins that are otherwise not available on the Internet.

Contents include

  • SOPs, checklists/gap analyses, test scripts and other validation tools
  • Publications with 10-30 pages on selected topics
  • Selected trendsetting FDA Warning Letters
  • Slides and Video clips from FDA presentations

For more details and ordering, click here

Standard Operating Procedures

FDA requires various routine activities to follow written procedures. Healthcare professionals typically use Standard operating procedures (SOPs) to address this. We offer model SOPs for standard processes such as training, writing SOPs and equipment qualification but also emerging needs such as risk based computer validation, risk assessment for GxP and Part11 compliance and for network qualification. SOPs are available in standard PDF format but also in MS word for easy customization.

More than 150 SOPs are available for

  • Generation and maintenance of SOPs
  • Training, developing URS and test scripts
  • Laboratory failure investigations, change control
  • Method, equipment and computer validation
  • And many more ..

To see the complete list and for ordering, click here

Examples - templates - checklists - case studies

Templates, examples and checklists make your validation work more efficient and consistent. Examples are useful to have an easy start and templates help to develop FDA friendly documentation. We offer examples, checklists and templates for al kinds of validation documentation from writing specifications to test protocols.

More than 50 examples are available for

  • Validation planning, writing specifications, installation qualification
  • Operational qualification, performance qualification, system suitability testing
  • Test scripts and protocols, traceability matrix
  • Documenting job requirements, tasks and trainings
  • User requirement specifications - Good and bad examples
  • Risk methodologies in laboratories
  • And many more ..

To see the complete list and for ordering, click here

Reference Papers

Reference papers written by Ludwig Huber, PhD, give a quick overview on selected topics related to validation and compliance. They are complementary SOPs and Examples. While SOPs and examples are useful for quick implementation, reference papers give the background information on regulatory and business requirements and approaches and strategies for implementation.

More than 20 reference papers are available for

  • Equipment Qualification, computer validation
  • Risk based validation
  • Method validation
  • OOS, CAPA
  • And many more ..

To see the complete list and for ordering, click here

Free Newsletter

Delivered on-line this Newsletter keeps you informed about regulatory and industry news. No matter if the FDA announces or releases new regulations or guidance documents or if they change their enforcement practices, you only need this newsletter to learn about all of this. We also inform our subscribers about new conferences and other new offerings from Labcompliance. Subscribers get a FREE DOCUMENT every month.

For ordering, click here.

Free Literature

Labcompliance a selection of free literature.

For ordering, click here.

Free Tutorials

Tutorials educate readers on selected topics. They should help to get a good understanding on USP, ICH, EMEA  and FDA requirements and strategies for implementation. Typically tutorials includes a primer with basic information and recommendations for implementation, expert advice on selected topics, links to warning letters, 483's and/or establishment inspection reports, literature references and links to other websites

Examples