(BDCP) Biopharmaceutical Development Certified Professional

The Biopharmaceutical Development Certified Professional (BDCP) program is ideal for individuals engaged in the discovery, development, manufacture and commercialization of recombinant DNA-derived biotechnology products (biopharmaceuticals) including, but not limited to, recombinant proteins, monoclonal antibodies, biosimilars, recombinant antigen vaccines and vaccines crafted from genetic material such as DNA, cellular immunotherapies, etc. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), one in four new medicines of the future will be biopharmaceuticals.

Due to the specifics in biotechnology, fulfilling the regulatory requirements in the development, manufacture and quality of biopharmaceuticals is a tremendous challenge. The biopharmaceutical development industry, as well as the regulatory authorities, are constantly faced with new and unexpected changes.

This CfPIE BDCP is designed to enhance the skills of those involved in all aspects of biopharmaceuticals and offers a multitude of course topics to match the needs of industry professionals. The development of this biopharmaceutical development program is in direct response to calls for focused training for the biopharmaceutical sector comprised of an extensive and diverse group of companies ranging in size from small start-up firms to multi-national, multi-billion dollar corporations. These companies provide the resources, both human and financial, that drive the discovery, development, testing, and production of new medical treatments.

Certification Program FAQs:

Certification Requirements:

  1. Choose 3 Core Courses from any of the courses listed below.
  2. Choose 1 Elective Course from any of our other classroom courses.
Skill Level Course Name
Advanced Specifications for APIs & Pharmaceutical Drug Products
Advanced Analytical Method Validation: Biologics & Biopharmaceuticals
Advanced Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Foundational Biosimilars - Understanding the Regulatory Challenges
Foundational Cleanroom Microbiology for the Non-Microbiologist
Foundational CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars
Foundational Comprehensive Overview of FDA Regulatory Compliance for Drugs & Biotech Products
Advanced Development and Validation of Bioanalytical Assays for Biologics
Foundational Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries
Foundational European Union Regulatory Issues – New Product Development
Foundational Filing Variations in the European Union
Foundational Good Manufacturing Practices Training | GMP Course
Foundational GMPs for OTC and Cosmetic Products – US and Global Requirement
Foundational Introduction to Molecular Biology Techniques – Applications in the Biotechnology and Pharmaceutical Industries
Foundational Process Validation for Drugs and Biologics
Advanced Product Quality Reviews
Advanced Quality Assurance/Quality Control for Biologics and Biopharmaceuticals
Foundational  The Drug Development Process from Concept to Market
Foundational Understanding Sterilization Methods for Products and Devices

If you have 10 or more employees that would benefit from biopharmaceutical development certification, we can offer complete program tracks on-site at your facility. For more information on our biopharmaceutical courses, call us at 1-610-648-7550 or contact us.

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