Good Recordkeeping Practice

Description

Good Recordkeeping Practice (GRK) training module for GMP 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 Recordkeeping Practice (GMP/GRK) training module are:

• To understand why following Good Recordkeeping Practice (GRK) 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 Recordkeeping Practice (GRK) is also known as Good Documentation Practice (GDocP) in other industries.

Good Recordkeeping Practice (GRK) Training

Who should take the GMP recordkeeping (regulatory compliance) training course?

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 to the Good Recordkeeping Practice (GRK) Training

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

Take the GMP Refresher course.

Course duration

Allow 1 to 2 hours to complete this course including the final assessment.

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 30 or more employees or want to train your entire team in multiple GMP compliance topics, contact us for a training package quote.