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

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

Certification TrainingProgram/Course ID: ELM-147
Enrollment Period: 3 months.
Allocated Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Good Manufacturing Practice (cGMP).
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $199.00

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

Training 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 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 within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


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

Objectives:


Skill Level:
Intermediate

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

GMP: Combination Products (Drugs, Devices and Biologics) - Part 3 is Included in the Following Professional Certification Program(s):



 Training Program For Professionals: 
cGMP: Combination Products for Professionals
Course ID: COMPR
Price: $495.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale (1-100 students) and large-scale (100+ students) training requests.


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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