Labcompliance Solutions
Compliance solutions help the healthcare industry to comply with FDA and
other regulations. 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
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 validation in
analytical laboratories and for computerized 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 have close 100 seminars in our offering. For a list of
recorded and upcoming seminars click on the link below
Labcompliance Users Club
Join the Users Club and instantly download more than 300 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 80 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
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
- 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