(PDCP) Pharmaceutical Development Certified Professional™

View Required Courses Certification FAQs

About the Pharmaceutical Drug Development Certification Program

Decreasing the time-to market is a primary goal shared by all pharmaceutical development professionals. While the initial designation of a development candidate is the ultimate goal of drug discovery research, the development professional must understand the wide range of issues involved in moving a product along the development timeline.

CfPIE’s Pharmaceutical Development Certified Professional (PDCP) certification program helps participants improve their pharmaceutical product development process skills. The PDCP 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.

Our PDCP program is designed to provide the training necessary to improve the proficiency of all product development professionals or those involved in the product development process. Pharmaceutical training topics covered include all aspects of the development process including, sound clinical practices, product advancement criteria, lead optimization, candidate criteria, Phase I through IV, QA/QC through regulatory review and approval.

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

Pharmaceutical 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, and Drug Metabolism in Drug Discovery and Development Analytical Chemistry Principles for Pharmaceutical Scientists Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products Auditing and Qualifying Suppliers and Vendors 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 Drug and Biotech Products Computer System Validation CRO, CDMO and Non-Clinical Vendor Management Fundamentals 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 GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirements Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies 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 Pharmaceutical Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy Preparation of FDA Submissions and Communicating with the FDA Preparing the CMC Section for NDAs/INDs/CTDs Process Validation for Drugs and Biologics QbD - Product and Process Optimization using Design of Experiments 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

Since 2006 CfPIE has