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Home » GMP: Combination Products (Drugs, Devices and Biologics) - Part 3

GMP: Combination Products (Drugs, Devices and Biologics) - Part 3 (ELM-147)

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 3
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 Reviews
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 3 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

Manufacturing and GMP Considerations
Introduction to Manufacturing Considerations
Pre-market Changes to Manufacturing Process
Post-market Changes to Manufacturing Process
GMP Considerations for Combination Products
cGMP Regulations: Individual Approach
cGMP Regulations: Hybrid/Streamline Approach
Additional 21 CFR 820 Specified Provisions - Part 1
Additional 21 CFR 820 Specified Provisions - Part 2
Case Studies
Case Study: Prefilled Syringe (PFS)
Case Study: Drug-Coated Mesh
Case Study: Drug Eluting Stent (DES)

Post-Market Safety Reporting
Introduction to Post-Market Safety Reporting
Consolidation of Requirements
Who is subject to the Combination Product PMSR final rule?
Combination Product PSMR Final Rule Example
Safety reporting requirements for Combination Product and Constituent Part Applicants
Reporting requirements for BOTH Combination Product Applicants and Constituent Part Applicants
Constituent part-based reporting requirements apply ONLY to Combination Product Applicants
Information sharing requirements apply ONLY to Constituent Part Applicants
Combination Product PMSR Requirements by Application and Product Type (PMSR - Appendix 1)

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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