Good Manufacturing Practice 01

Description

Good Manufacturing Practice 01 (PIC/S GMP Part 1)

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Good Manufacturing Practice 01 (GMP Part 1) – Online GMP Training Course

The objectives for this GMP Part 1 training course are to:

• introduce Good Manufacturing Practice (GMP Part 1) regulations relating to the manufacture of medicinal products, including contract manufacturing
• understand common GMP industry terms and definitions
• emphasise the importance of compliance with PIC/S GMP / cGMP regulations
• explain the importance of establishing an effective Pharmaceutical Quality System (PQS) or Quality Management System (QMS)
• overview Good Manufacturing Practice compliance responsibilities for personnel, suppliers and contractors and help them be better prepared for self-inspections and audits
• learn the importance of production quality controls
• understand the basics of good documentation practices relating to correcting errors, date formats, etc.
• explain Risk Management principles and how managing quality, safety and efficacy risks helps ensure patient safety
• reinforce the 10 Golden Rules of GMP
• provide an orientation to Regulatory Authorities such as the Food and Drug Administration (FDA) in the USA, the Therapeutic Goods Administration (TGA) in Australia, the European Medicines Agency (EMA) in Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) in UK, etc.
• reinforce the culture of GMP compliance within your organisation

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Good Manufacturing Practice 01 (PIC/S GMP Part 1) training

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Who should complete this course in Good Manufacturing Practice (GMP Part 1) regulations compliance?

This Good Manufacturing Practice (GMP) PIC/S GMP Part 1 course is suitable for:

• Any new or existing Manufacturing and Quality department personnel, suppliers or contractors involved in operations pertaining to medicinal products
• Anyone needing to understand Good Manufacturing Practice (GMP) regulations for medicinal products
• Anyone requiring a GMP Training Certificate
• Individuals applying for current job openings in the Pharmaceutical Industry (e.g. in the USA or Australia)

Course Duration

• Allow an average of 1.5 hours to 2.5 hours to complete this online training course including the Final Assessment.
• You can access the course online 24/7, once you complete your online purchase.
• You will continue to access this course for a period of 12 months from the date of purchase.

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Certificate GMP Course for Good Manufacturing Practice (GMP Part 1)

Is this a Certificate GMP course?

• Successful completion of the Final Assessment for the training course on Good Manufacturing Practice 01 (GMP Part 1) provides you with a Certificate of Completion for the GMP training topic.
• To attain a GMP course certificate of completion, simply spend time reviewing the online course materials, take the Quick Quizzes to test your knowledge, and then successfully complete the online Final Assessment for the course.
• After successful completion of each course, you’ll have the option of printing or saving 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 Part 1 training Certificate of Completion to your Quality Manager, Supervisor or Personnel Hiring Department for GMP industry job openings.

Pre-requisites for this training GMP Part 1 course:

• There are no formal pre-requisites for this GMP Part 1 course.
• However, the 10 Golden Rules of GMP may be a helpful course as an orientation to the principles of GMP compliance, depending on previous experience in a regulated sector.
• The training course should be combined with onsite training programs and workplace Supervision.

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Other recommended Good Manufacturing Practice training courses:

The following GMP courses are crucial for success in highly-regulated industries:

• Good Record-Keeping Practice (Good Documentation Practice)
• Good Manufacturing Practice 02 (GMP Part 2)
• Other PIC/s requirements for Annexes 1 through 20 are available from this training store page
• Good Laboratory Practice (GLP nonclinical)
• GMP Refresher training
• Please see our other courses in the event you need training on FDA’s CFRs 210 & 211, CFRs 800 & 820

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Ask your Employer for details or visit our industry-specific training bundles.

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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 in conjunction with specific onsite GMP training and Supervision as required in the pharmaceutical manufacturing sectors.

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 GMP02/GMP Part 2 if working with APIs, and industry-specific courses.

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Do you have to be currently employed in the Pharmaceutical Industry to take a Certificate GMP Course such as GMP01?

• 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.
• 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.

References: PIC/S Guide to GMP Part 1 (PIC/S Publications)

Page last updated on April 28, 2021.