FDA Title 21 CFRs Part 210 and Part 211 for Finished Pharmaceuticals

Description

FDA CFRs Part 210 and Part 211 for Finished Pharmaceuticals (Introductions)

US FDA CFRs, Title 21, FDA Regulatory Compliance Requirements for Finished Pharmaceutical Products

This interactive eLearning course discusses the US FDA CFRs (Title 21) covering Good Manufacturing Practice (GMP) legislative requirements for manufacturing pharmaceutical products.

This course introduces learners to the need to comply with GMP requirements in the US FDA CFRs Part 210 and Part 211 and related FDA regulatory compliance guidance publications.

It includes an overview of other relevant regulations that learners should explore, such as specific regulations and guidance applicable to biological products and sterile medicines.

US FDA CFRs Part 210 and Part 211 cover GMP for Finished Pharmaceutical Products.

If you are searching for the US FDA CFRs Part 800 and Part 820 for medical Device manufacturing regulations, click here.

About this online GMP training course

This course will help manufacturing personnel, Operations Leaders, Quality Managers/Quality Associates, contractors and vendors learn the history and key concepts of GMP regulations for finished pharmaceuticals.

US FDA = United States Food & Drug Administration 

CFRs = Code of Federal Regulations

The course is linked to the top 10 FDA warning letter findings and will assist new QA and supervisory personnel in navigating these lengthy regulations.

Who should complete this FDA CFRs Part 210 and Part 211 training course?

This course is generally suitable for personnel working in pharmaceutical manufacturing operations, Quality Control, Quality Management, and validation or engineering roles. The guidance covered in this course applies to finished pharmaceutical products being marketed/distributed in the United States (US) under the FDA’s jurisdiction.

• This course is a self-paced, online training course covering the US regulations/FDA requirements of (Title 21) FDA CFRs Part 210 and Part 211.
• This GMP eLearning course covers regulations and GMP responsibilities applicable to a variety of job roles/responsibilities.
• Successful completion of this GMP training course and Final Assessment (entirely online) will provide learners with a downloadable/printable GMP Certificate of Completion for FDA CFRs Part 210 and Part 211 to attach to the individual’s CV and include in their personnel files (an important step for GMP compliance audits).
• The GMP Training Course Certificates of Completion are dated and signed and available in a downloadable PDF or printable format.

Online Training Options for FDA CFRs Part 210 and Part 211 – Compliance eLearning courses by PharmOut

How long will you have access to this GMP eLearning course for FDA CFRs Part 210 and Part 211?

• Learners will have 12 months’ access to this training presentation/online course for FDA CFRs Part 210 and Part 211.
• One learner per course licence.

Do you have discounted GMP training for large groups of people and/or multiple GMP education topics?

• Ordering up to 50 courses per person is best completed by using bundled GMP training package options (search the GMP store for bundled options).
• If you need to train large groups of employees (100 or more) in several different courses, you can contact us for information.
• Orders should generally be completed online using a credit card payment method.

 

• In addition to eLearning, we offer Zoom-based GMP compliance courses (subject to availability) in numerous locations.
• We also offer pharmaceutical industry audit preparation services, third-party ‘self-inspections’, and audit response letter support.

Pharmaceutical Industry GMP Education Topics including compliance with US FDA CFRs Part 210 and Part 211 for finished pharmaceuticals

Visit our other GMP compliance education options including preparing for an audit, CAPA system requirements, recalls training, complaints management, GMP data integrity requirements, and more.

Disclaimer: This GMP Training Course is part of a suite of GMP education topics for regulatory compliance training programs. It is intended for education purposes only. In many cases, this course should be taken at least annually. Refer to FDA warning letters regarding GMP training non-compliance issues.

This course is not a replacement for onsite training, product-specific training, and appropriate levels of Supervision.