Good Documentation Practice (Good Recordkeeping Practice)

Description

Good Documentation Practice (Good Recordkeeping Practice) training module to support compliance with cGMP documentation requirements.

GMP: Good Recordkeeping Practice (GRK)

There are many rules to comply with regulatory expectations for recordkeeping in GMP environments, including Good Recordkeeping Practice (GRK) for incoming material receipts, batch records, and batch certification/batch release authorisations. You can learn about GMP recordkeeping requirements (including ALCOA+ rules) in this convenient GMP Certificate Training Course (online).

The objectives of this Good Documentation/Good Recordkeeping Practice eLearning course are:

• To understand why following Good Documentation Practice (Good Recordkeeping) is an important part of GMP compliance
• To understand the acronym ALCOA+(+) as it relates to recordkeeping (documentation requirements including online documentation systems)
• To understand how to delete or strike out errors when keeping records
• To understand what you should do when creating records
• To understand what you should not do when creating records
• To learn the principles of GRK and good documentation practice (GDocP) including the principles of good recordkeeping practice (Good Documentation Practice)

Good Documentation Practice (GDocP) is also known as Good Recordkeeping Practice (GRK) in GMP industries and other regulated industries. It is a crucial component of ensuring Data Integrity (DI), which you can learn about here.

Good Documentation Practice (GDP) Training

Who should take the GMP ‘good documentation’ training course?

Compliance requirements for cGMP documentation (good recordkeeping):

All employees of regulated industries, including medical and healthcare employees, pharmaceutical manufacturing employees, logistics employees, and pharmaceutical and medical device employees, suppliers and contractors, need to adhere to Good Documentation Practice / Good Recordkeeping Practice (GRK) including ALCOA+.

This course is suitable for a wide range of employees/contractors in the life science sectors, including professionals and contractors working in pharmaceutical manufacturing, medical device manufacturing, veterinary medicines production, hospitals, and laboratory environments.

This course should ideally be taken on at least an annual basis to keep good recordkeeping practices (including ALCOA+ principles) clearly in mind.

Prerequisites

Course prerequisites for completing Good Documentation Practice (GDocP)/Good Recordkeeping Training (online)

• There are no formal prerequisites for this ‘good documentation/good recordkeeping’ training course.
• However, you may require GMP training and product-specific training in other cGMP compliance requirements including the 10 Rules of GMP, Data Integrity, and Preparing for an Audit.
• A good follow-up training course for some professionals is the GxP (GAMP5) computerised systems requirements in GMP environments.

Need a current GMP training certificate? Complete the GMP Refresher Training course.

To order, add this Certificate GMP eLearning course to your cart (one user per licence) and after completing your purchase, search your email folders for your login information. If you need to order training for large groups of employees, or want to train your entire team in multiple GMP compliance topics on an as needed basis, consider the training bundles – or contact us directly for a training package quote.