Pharmaceutical & Biotechnology Training Courses Overview

It’s no secret: the pharmaceutical and biotechnology industries are constantly changing. Keeping track of any and all updates – and staying ahead of the competition – is difficult.

Benefits of our Pharma & Biotech Training Courses

Our pharmaceutical and biotechnology training courses allow you to:

Improve day-to-day productivity and enhance long-term career prospects.
Our biotechnology and pharmaceutical courses help you stay up to date on evolving regulations, increasing competition, and advancing scientific discoveries with content developed and taught by expert, industry-active instructors.
Satisfy scientific, administrative, regulatory compliance, and marketing needs, with pharmaceutical and biotechnology courses at every level of experience.
Minimize potential problems by training lab, clinical, and manufacturing personnel to industry best practices for improved efficiency and profitability throughout product lifecycles.
Earn valuable pharmaceutical and biotechnology certifications.

Topic Areas Include

Adverse drug events
API specifications
Best practices (GCP, GLP, GMP)
Clinical trials
Drug discovery and development
FDA regulatory compliance
Immunology
Microbiology training
Process validation
Product shelf life
Quality assurance and quality control

ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development Advanced Topics in Biostatistics for Non-Statistician Analytical Method Validation: Biologics & Biopharmaceutical Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products Auditing and Qualifying Suppliers and Vendor Best Practices for an Effective Cleaning Validation Program Biostatistics for Non-Statistician Cleanroom Fundamentals: Regulation, Science, Design, Practice, Operation and Management Clinical Document Management: A Trial-by-Trial Compliance Approach 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 Product Computer System Validation Development and Validation of Bioanalytical Assays for Biologic Effective Document Management for Pharma, Biotech & Medical Device

Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries European Regulatory Procedures - EMA and National Requirement FDA Inspections - What Regulators Expect and How to Prepare GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trial GMP Training for the QC Laboratory GMPs for OTC and Cosmetic Products – US and Global Requirements Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirement Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies Good Manufacturing Practices Training | GMP Course Implementing an FDA Compliant Stability Program Integration of Risk Management Principles and Activities into the Quality System Introduction to Medical Combination Product Molecular Biology Techniques – Applications in the Biotechnology and Pharmaceutical Industries Introduction to Statistical Analysis of Laboratory Data Laboratory Equipment Validation and Qualification

Lyophilization Technology – Practical Application of the Scientific Principles Marketing & Advertising of Pharmaceutical & Medical Device Pharmaceutical Production Batch Record Review | Training 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-CTDs-IND Process Validation for Drugs and Biologics Quality Assurance/Quality Control for Biologics and Biopharmaceutical QbD: Product and Process Optimization using Design of Experiments Selecting and Managing CROs Specifications for APIs & Pharmaceutical Drug Product Technical Writing for Pharma, Biotech and Med Device The Drug Development Process - From Concept to Market Writing Effective SOP and Other Process Documents Writing Effective SOP and Other Process Documents

ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development Advanced Topics in Biostatistics for Non-Statistician Adverse Drug Events - Reporting & Regulatory Requirement Analytical Method Validation: Biologics & Biopharmaceutical Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products Auditing and Qualifying Suppliers and Vendor Basic GMP Training for the QC Laboratory Best Practices for an Effective Cleaning Validation Program Biostatistics for Non-Statistician Cleanroom Fundamentals: Regulation, Science, Design, Practice, Operation and Management Clinical Document Management: A Trial-by-Trial Compliance Approach Clinical Trial Project Management, Phase 1-4 Best Practices CMC Regulatory Compliance Strategy for Recombinant Proteins, Monoclonal Antibodies, & Biosimilars CMC Regulatory Compliance Strategy for Cell & Gene Therapy Medicines Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product Computer System Validation Development and Validation of Bioanalytical Assays for Biologic

Effective Document Management for Pharma, Biotech & Medical Device Effective Internal and External Quality Assurance Auditing for FDA Regulated Industries European Regulatory Procedures - EMA and National Requirement European Union Regulatory Issues – New Product Development FDA Inspections: What Regulators Expect and How to Prepare GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trial GMPs for OTC and Cosmetic Products – US and Global Requirements Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirement Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies Good Manufacturing Practices Training | GMP Course Implementing an FDA Compliant Stability Program Integration of Risk Management Principles and Activities into the Quality System Introduction to Medical Combination Product Molecular Biology Techniques – Applications in the Biotechnology and Pharmaceutical Industries Introduction to Statistical Analysis of Laboratory Data Laboratory Equipment Validation and Qualification Lyophilization Technology – Practical Application of the Scientific Principles

Marketing & Advertising of Pharmaceutical & Medical Device Pharmaceutical Production Batch Record Review | Training 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 MAAs-IMPD Preparing the CMC Section for NDAs-CTDs-IND Process Validation for Drugs and Biologic Quality Assurance/Quality Control for Biologics and Biopharmaceutical QbD: Product and Process Optimization using Design of Experiments Selecting and Managing CRO Specifications for APIs & Pharmaceutical Drug Product Technical Writing for Pharma, Biotech and Med Device The Drug Development Process - From Concept to Market Writing Effective SOP and Other Process Documents US Cosmetic Regulation: FDA CFR Title 21 Training Writing Effective Monitoring Reports and Good Documentation Practices: A Symbiotic Relationship Writing Effective SOP and Other Process Documents

Customized On-Site Training

Many of our robust biotech and pharmaceutical training courses are also available for instruction at your company’s locations. We offer custom on-site training to help you satisfy specific disciplines and enhance cross-discipline exposure in a tailored format to best suit your needs.

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Pharmaceutical & Biotechnology Certification

Our Certification Program has been utilized by hundreds of pharmaceutical and biotechnology professionals. These industry-recognized pharmaceutical training certifications can help you enhance your credibility and expand your career options – all at no additional cost above standard course fees!

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ABOUT US

The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site, and certification programs.

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128 Pottstown Pike
Chester Springs, PA 19425 USA

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