Implementing efficient practices that meet full GLP/GMP/ISO and FDA requirements
On this page...
Benefits of attending for
you and your company
At the end of the course you will...
what the GMP regulations and ISO guidelines require of the documentation function
how the policies and culture of your company impact the documentation function,
and how to strategize to implement a successful documentation function
what is required to establish a sound documentation function within your company
or within your department
where the corporate and cultural “road blocks” are, and either how to
avoid them, or how to best steer around them
Who Should Attend
Personnel involved with managing the documentation function at a corporate, division
or departmental level.
The course will also be of extreme interest to quality assurance personnel, particularly
quality assurance auditors, seeking to know what makes for a sound documentation
The course is presented in English
Documentation of production and analytical methods (standard operating procedures),
product specifications, facility and parts drawings, technology transfer documents,
validation protocols and batch record documentation are the most vital tools available
for assuring product quality, integrity and consistency.
Establishing and managing an efficient and effective, non-bureaucratic documentation
system that meets operational and regulatory needs is a major challenge. Doing
so without becoming a systems bottleneck is a formidable task, especially when
the needed staff are "never available"! The course is designed to review
the complete documentation function and provide insight into the right and wrong
ways of establishing and managing this essential function.
Some companys documentation systems are, by their very design, doomed to
provide inferior and inefficient service to meet user and regulatory needs. The
course provides examples of both effective and regulatory needs. Current paper
systems and newly developed electronic systems are presented and discussed.
- The purpose of documentation
- Regulatory GLP and GMP issues
- FDA requirements for electronic signatures and records (21CFR11)
- Business considerations
- User expectations
- System requirements
- Establishing the documentation function
- Activities related to document production
- Convert your paper SOP system to an electronic system TOMORROW !
- Document types (similarities and differences)
- Creating documents that help users work right
- ISO 9000 and documentation
- Signatures and initials: what they mean
- Records and reports:
- Logs, Deviation Reports
- Batch Production and Packaging Records
- Laboratory Records
- Calibration and Maintenance Records
Previous Participant Testimonials
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