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GMP for clinical trials manufacture and supply

 5/5

8

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course :

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

As much as GMP is important for drugs that are approved to market by the FDA/EMA, it is equally pivotal for investigational medicinal products that are still undergoing clinical trials. Understanding and applying current GMP requirements to practice while manufacturing clinical trial material ensures that the investigational drugs and medicinal products are consistently produced under stringent quality control activities.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum:

Introduction

Lesson 1: Quality Management of IMPs

Lesson 2: Quality Risk Management

Control, Communication, and Review of Quality Risks

Lesson 3: Personnel Management

Lesson 4: Documentation of IMPs

Manufacturing Formulae & Packaging Instructions
Labeling Instructions
Batch Manufacturing Records
Coding Systems

Lesson 6: Production for Clinical Trials Manufacture

Manufacturing operations
Packaging and Labeling
Blinding

Lesson 7: Qualification and validation

Lesson 8: Recalls and market returns

Lesson 8: Shipping

Lesson 9: Destruction

Glossary

Conclusion

Evaluation

Author:

Dr. Ciaran McEnister

Senior Pharmaceutical Executive with 25+ years of experience in medical device development. Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager.

Reviews:

 5/5

8

High quality course. Very interactive.

$60

Participant(s):

Buy now

Large group ? Request a quote !

This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.