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Wednesday, December 01, 2021
Home » Regulatory Affairs: Essentials of Monoclonal Antibodies

Regulatory Affairs: Essentials of Monoclonal Antibodies

Certification Training
 
Rated 4.05/5
21 reviews
Program/Course ID: PRA24
Enrollment Period: 6 months.
Average Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 1 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Pharmaceutical Regulatory Affairs.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $145.00 USD  

Document your dedication to compliance, safety, and job performance by earning a training certification from Biopharma Institute

Training Program: Regulatory Affairs: Essentials of Monoclonal Antibodies
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

Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical diagnosis, in laboratory analysis, and in the biotechnology industry itself.

This module will introduce you to monoclonal antibodies, explaining how they work, how they are made, and the many uses to which they are put.

Once all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

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:


Module overview - An outline of the module's scope and objectives, and notes on terminology.

Structure and functions of antobodies - In this session we discuss the role of natural antibodies and outline how the dream of creating 'magic bullets' to fight disease has been realised. We identify the structural components of antibodies and describe their actions. We distinguish types of monoclonal antibody by their non-human and human components. Finally, we sketch how some therapeutic mAbs can be linked to cell-killing agents to increase their effectiveness against cancer.

Production of mAbs - Production of a mAb proceeds from the generation of a cell line possessing the mAb's gene sequence, through bulk cell culture, to isolation and purification of the antibody. In this session we describe options for generation of the cell line, we outline the downstream production processes, and we identify important issues for the assurance of product quality.

Uses of mAbs - In this session we describe the wide range of uses for mAbs in laboratory analysis, in-vivo diagnosis and therapy, and purification in the biotechnology industry. We give examples of mAb products in each category of application.

Assessment - Multiple-choice mastery assessment.

Objectives:


Who will benefit from this module? This module will benefit anyone educated in science to high school level or beyond who wants an introduction to the basics of monoclonal antibodies.

Objectives - Describe the structure and function of antibodies in the body - Distinguish types of monoclonal antibody by their source and constitution - Outline important factors in the production of mAbs - Identify major uses of mAbs

Regulatory Affairs: Essentials of Monoclonal Antibodies is included in the following professional certification programs:



Professional Certification Program:

International Pharmaceutical Regulatory Affairs Professional Certification Program

Course ID: PRA00A1
Price: $1795.00 (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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