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Home » GMP: Combination Products (Drugs, Devices and Biologics) - Part 2

GMP: Combination Products (Drugs, Devices and Biologics) - Part 2 (ELM-146)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Good Manufacturing Practice (cGMP).
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GMP: Combination Products (Drugs, Devices and Biologics) - Part 2
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThis course will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manufacturing and GMP considerations. In addition, we'll provide links to more in-depth information on certain topics as we move through the course. An additional goal of this course is to provide an understanding and overview of the variety of regulatory and review challenges presented by combination products as compared with single-entity products.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


GMP: Combination Products (Drugs, Devices and Biologics) - Part 2 course is included in the following Professional Certification Programs:



Combination Products for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Introduction
Course Overview
Learning Objectives
Who Should Take This Course?
Terms Explained
Course Modules

Regulatory Submission Pathway
Lead Center Assignment
Product Examples
What Determines the Marketing Authorization Type for Combination Products?
FDA Guidance on Premarket Pathways for Combo Products
Clarity on Pre-market Interactions with the FDA
Pre-market Submissions for Combination Products
Annex: Examples of Device-Led Combination Products
Electronic Application Format
Early Interaction / Feedback - Part 1
Early Interaction / Feedback - Part 2

Clinical Trials
Clinical Trial Considerations
Device Constituent Parts
Drug and Biological Product Constituent Parts
Additional Drug/Device Considerations
Clinical Investigation
Oversight of Clinical Investigations
Human Factor Studies
FDA Human Factors Guidance - Part 1
FDA Human Factors Guidance - Part 2
Sterility Requirements
Stability Requirements for Combination Products
Stability Testing for Combination Products
Special Considerations for Stability Testing - Part 1
Special Considerations for Stability Testing - Part 2
General CMC Issues for Combination Products

Conclusion


Final Assessment


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of Combination Products (Drugs, Devices and Biologics).

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

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