GMP Refresher Training

Description

GMP Refresher Training (Online GMP Compliance Course)

This GMP Refresher training suits a global audience and can be completed entirely online, including the assessment which provides a dated Certificate of Attendance for personnel training records.

Objectives for this Good Manufacturing Practice Refresher (GMP Refresher) training course:

• Refresh personnel knowledge of their responsibilities to comply with current Good Manufacturing Practice (cGMP)
• Remind personnel of Regulatory Authority expectations including inspections/audits
• Reinforce GMP compliance understandings relating to:
  • Pharmaceutical Quality System (PQS)
  • Personnel hygiene
  • Premises and Equipment
  • Documentation/recordkeeping
  • Production
  • Quality Control
  • Outsourced activities (contracts)
  • Complaints and Product Recalls
  • Self Inspection
• Recap the 10 Golden Rules of GMP

Certificate GMP Refresher Training Course

Who should complete this Good Manufacturing Practice Refresher training course?

• Any new or existing Manufacturing and Quality department personnel, suppliers or contractors involved in operations pertaining to medicinal products/pharmaceuticals
• Anyone needing to understand GMP rules and quality standards in regulated environments
• Anyone requiring annual GMP Refresher Training documentation (GMP Training Certificate) to demonstrate ongoing compliance training
• Individuals applying for current job openings in the Pharmaceutical Industry (including in the USA, UK, EU and/or Australia)

Note: The training is suitable for anyone working in a GMP environment. It focuses on general principles of current Good Manufacturing Practices (cGMP), PIC/S GMP Guide publications, and recent GMP trends.  It gives several regional examples, but is not specific to a particular Regulatory Authority, agency or specific code of GMP.

Duration of the online GMP Refresher training course

• This course will take approximately 1 hour to 1.5 hours, including the Final Assessment for the GMP Training Course Certificate of Completion. Some learners will finish this course in a shorter time period.
• Registered learners (purchasers) can access the course online 24/7 after completing the course purchase.
• Access this course continues for a period of 12 months from the date of purchase.
• One user per licence.
• If you are buying for an employee, be sure you click the ‘gift’ button and enter their details as the registrant/recipient.

Certificate GMP Course for Good Manufacturing Practice Refresher

Training records for online GMP courses

• Successful completion of the online Final Assessment for training courses will provide you with a Certificate of Completion for the GMP training topic.
• To attain a GMP course certificate of completion, spend time reviewing the GMP elearning training materials, complete the Quick Quizzes to test your knowledge and understandings of GMP responsibilities, and successfully complete the online Final Assessment for the topic.
• You’ll then have the option of saving and printing a personalised GMP Training Certificate that meets general PIC/S GMP and EU GMP regulatory expectations.
• You can download/save, print and/or forward the GMP Refresher training Certificate of Completion to your Quality Manager, Supervisor or Personnel Hiring Department for GMP industry job openings.

There are no pre-requisites for this GMP Refresher course, however, it assumes the learner has a basic understanding of GMP.

• There are no formal pre-requisites for this GMP Refresher training course, however, learners should have existing knowledge of GMP requirements.
• For example, the Good Manufacturing Practice Part 1 (GMP01) training course and the 10 Golden Rules of GMP may helpful courses for GMP training orientations, depending on previous experience in a regulated sector.

The online GMP training course should be combined with onsite training programs and workplace Supervision.

Other recommended Good Manufacturing Practice training courses:

The following other courses crucial for success in a GMP environment are recommended after the completion of this GMP Refresher training course:

• Good Manufacturing Practice 01 – Finished pharmaceuticals (GMP Part 1)
• Good Manufacturing Practice 02 – Active Pharmaceutical Ingredients – APIs (GMP Part 2)
• Good Record-Keeping Practice (Good Documentation Practice)
• Other PIC/s requirements for PIC/S Annexes 1 through 20 are available from our GMP elearning course options
• Please see our GMP elearning course options if you need compliance training for the US FDA’s CFRs 210 & 211, CFRs 800 & 820, ISO 13485 and other training courses
• Ask your Employer for details or visit our industry-specific training bundles.

GMP Training | Education purposes only

• These courses are intended for use as GMP orientation training courses/GMP Industry education resources.
• They are designed to be used as supplemental GMP training, orientation training, and annual refresher courses.
• They can be used in conjunction with or in addition to specific onsite GMP training and appropriate Supervision as required in pharmaceutical manufacturing organisations.

It is helpful for learners to develop deeper understandings of basic GMP principles and GxP compliance regulations, such as through learning the GMP topics covered in GMP01/GMP Part 1 for medicinal products and GMP02/GMP Part 2 if working with APIs, and industry-specific courses.

FAQs about GMP eLearning

Do you have to be currently employed in the Pharmaceutical Industry to take a Certificate GMP Course such as GMP Refresher?

• You do not have to be currently employed to complete this GMP Refresher training.
• The course is open to anyone with an interest in the Pharmaceutical Industry, GMP compliance requirements for working with medicinal products during pharmaceutical manufacturing or supply chain transportation, and related manufacturing topics.
• However, because it is a Refresher course, it is suitable for individuals with previous experience in or basic knowledge of GMP/GxP compliance requirements.
• Other relevant courses can be found in our list of online GMP training courses / cGMP training options.
• Good Recordkeeping practice training is also recommended for all employees as recordkeeping and documentation are often cited in warning letters from Regulatory Authorities such as the TGA, MHRA and FDA.