Who will the course benefit?
This GMP Documentation training course will suit new, as well as established, Document Controllers, QA and QC personnel and technical personnel involved in generating, approving and using GMP documentation and records. The GMP Documentation training course is full of practical tips and advice for having a well-managed documentation system will explode some of the myths, remove some of the complexity and re-focus upon the rules and guidance and how they are applied.Course overview:
Our GMP Documentation training course covers the practical day-to-day implementation of Good Manufacturing Practice requirements for documentation and records; including the current EU and USA GMP requirements. The course covers requirements for paper based, electronic and hybrid systems.The many different types of GMP documents and records are discussed along with the principles of version control, authorisation, issuing and control of changes. The course also covers the content of documents, and how they should be worded and laid out. Guidance is given on how to control in-house documents and includes practical ways of managing other types of controlled company information, external reference material and publications such as pharmacopoeias and technical manuals.
The issues surrounding validation and security of certain types of record, record keeping and data management are also included, including the requirements for archiving and retrieval of information as well as the latest expectations with regard to data integrity.
The GMP Documentation training course also covers the use of electronic records and use of electronic signatures (including 21 CFR Part 11) explaining the different ways documents and data information can be authorised by utilizing modern technologies.
We now have a 20-minute online Data Integrity course designed to bring your team up to speed on this important topic - visit our website for more details
Course contents:
- GMP requirements for documents and records
- Why control documents and information?
- Different types of documents and records and their content
- Good document and record design
- Approval of documents
- Paper versus electronic systems
- Use of electronic signatures
- Completion of records
- Data integrity
- Archiving and retrieval of paper based and computer based systems
- Common regulatory findings
