(BDCP) Biopharmaceutical Development
Certified Professional™

View Required Courses Certification FAQs

About the Biopharmaceutical Development Certification Program

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). The BDCP certification program is available for individuals in the United States, Europe, Canada, Australia and Middle Eastern countries. Full List of Countries where we offer Pharma & Biotech and Medical Device Courses.

The program includes, but is not limited to, recombinant proteins, monoclonal antibodies, biosimilars, recombinant antigen vaccines and vaccines crafted from genetic material such as DNA, cellular immunotherapies, and more.

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 without comprehensive pharmaceutical training. The biopharmaceutical development industry, as well as the regulatory authorities, are constantly faced with new and unexpected changes.

Who Is The Biopharmaceutical Development Program Right For?

This CfPIE Biopharmaceutical Development Certified Professional (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.

Contact a Training Advisor

We offer on-site pharmaceutical training and life science certification programs for organizations with 10 or more employees enrolling. Call us today at 1-610-648-7550 or Contact a Training Advisor.

Proceed To Required Courses Certification FAQs

Biopharmaceutical Development Certification Requirements:

Choose 3 Core Courses from any of the courses listed below.
Choose 1 Elective Course (Can be a core course or any course listed at: Courses by Title)

ADME, PK/TK & Drug Metabolism in Drug Discovery and Development Analytical Chemistry Principles for Pharmaceutical Scientists Analytical Method Validation: Biologics & Biopharmaceuticals Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products Auditing and Qualifying Suppliers and Vendors Best Practices for an Effective Cleaning Validation Program Biostatistics for Non-Statisticians Change Control - GMP Requirements and FDA Enforcement Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management Clinical Trial Project Management, Phase 1-4 Best Practices CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, & Biosimilars Comprehensive Overview of FDA Regulatory Compliance for Drugs & Biotech Products Computer System Validation Development and Validation of Bioanalytical Assays for Biologics: Quantitation (PK) and Immunogenicity Assays Effective Document Management for Pharma, Biotech & Medical Device Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries Ethics in Research - Values for Responsible Conduct of Research FDA Inspections - What Regulators Expect and How to Prepare GMP Training for the QC Laboratory Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirements Good Manufacturing Practices Training | GMP Course

Human Error Prevention (HEP) - Risk Factors and Strategies Implementing an FDA Compliant Stability Program Integration of Risk Management Principles and Activities into the Pharmaceutical Quality System Introduction to Medical Combination Products Introduction to Statistical Analysis of Laboratory Data Introduction to Vaccines - CMC Regulatory and Quality Aspects Laboratory Equipment Validation and Qualification Lyophilization Technology - Application of Scientific Principles Molecular Biology Techniques - Applications in the Biotechnology and Pharmaceutical Industries Oncology Drug Development Course - A Comprehensive Overview OTC Drug and Personal Care Product GMP & FDA Regulation Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy Preparation of FDA Submissions and Communicating with the FDA Process Validation for Drugs and Biologics Quality Assurance/Quality Control for Biologics and Biopharmaceuticals RNA Biotechnology - An Introductory Course Specifications for APIs & Pharmaceutical Drug Products Technical Writing for Pharma, Biotech and Med Devices The Drug Development Process from Concept to Market Writing Effective SOP and Other Process Documents

Certification Program Discounts

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

Pharma & Biotech Courses

Medical Device Courses

Skin & Cosmetics Courses

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