Biotechnology Training

WHY IS BIOTECHNOLOGY TRAINING IMPORTANT?
Biotechnology training is needed to fill the void between the curriculum of a theoretical education and the practical demands of - depending on your specialty - R&D, validation, regulations, processing, or manufacturing in the biotechnology field. Furthermore, proper biotechnology training is essential due to the complexity and inherent uncertainty of using living organisms as production systems to manufacture complex, biologically active proteins.

See which Biotechnology
Training Courses can help you.

As the leader in continuing education and accredited technical training, The Center for Professional Advancement (CfPA) offers the most comprehensive and up-to-date selection of biotechnology courses. Our biotechnology training courses - including biotechnology online courses - run from one- to five- days in length, include discussions, case studies, and group exercises and are taught by top industry leaders who share their knowledge in an enthusiastic, interactive manner.

Biotechnology Training Courses

WHAT BIOTECHNOLOGY COURSES FOCUS ON TECHNOLOGIES AND PROCESSES?
The following CfPA biotechnology courses focus on technologies, applications and processes used in the biotechnology, pharmaceutical and allied industries:

Conducting Compliant Endotoxin Testing - Describe the elements of compliant endotoxin testing and onduct tests according to the USP Bacterial Endotoxins Test chapter. View this biotechnology course now.
Control of Microbial Contamination in Manufacture of Sterile and Non-Sterile Products - Provides an overview of the sources of microbial contamination and how to control such contamination. View this biotechnology course now.
Strategies for Leveraging PAT/QbD in Biologic Applications - Understand critical decision-making tools, from inoculation and transfer issues through predictive operation control to product release, fill and finish -and patient use. View this biotechnology course now.
Lyophilization Technology - Get an up-to date understanding of the theory and practice of lyophilization. Biotechnological and pharmaceutical applications will be emphasized. View this biotechnology course now.
Near Infrared Spectroscopy - Get an overview of modern NIR. This biotechnology course covers the optical, spectroscopic, and mathematical principles on which this technique is based. View this biotechnology course now.

See which Biotechnology
Training Courses can help you.

WHAT BIOTECHNOLOGY COURSES FOCUS ON VALIDATION AND/OR REGULATIONS?
The following CfPA biotechnology courses focus on regulations and/or validation for the biotechnology, pharmaceutical and allied industries:

Biosafety of Biological Drug Products - An introduction to the unique perspectives and considerations of safety testing of biological drug products in contrast to typical safety testing of chemically-derived pharmaceuticals. View this biotechnology course now.
CMC Submissions in CTD Format - Get an in-depth review of the CMC requirements for development and ultimate submission to the FDA and European regulatory bodies in the new drug application (NDA). View this biotechnology course now.
Complaint Systems - The Essential Requirements - Get a step-by-step guide to the essential requirements of a Complaint System for today's FDA regulated industry environment. View this biotechnology course now.
Conducting Effective Quality Audits - Take this overview course if you have recently been involved or expect to be involved in external or internal audits. View this biotechnology course now.
Microbiological Control and Validation - Understand microbiological control in manufacturing, laboratory auditing and sterilization. View this biotechnology course now.

WHEN AND WHERE CAN I GET BIOTECHNOLOGY TRAINING?

Browse the Biotechnology Courses including Biotechnology Online Courses listed below. CfPA can also bring any Biotechnology Course to your location. Please click here for more information about our
Client-Site Programs.

Course Title	Scheduled
A Survey of Microbiology for the Pharmaceutical, Biotechnology, and Medical Device Industries
ADME Fundamentals
An Overview of Documentation Requirements in FDA Regulated Industries
Applied cGMPs for Pharmaceutical and Allied Industries
Assuring Quality of Supplies to Pharmaceutical and Related Industries
Auditing and Inspecting Preclinical Research for GLP Compliance
Best Practices in SAS Statistical Programming for Regulatory Submission
Best Practices in SAS Statistical Programming for Regulatory Submission: Creating Publication-Quality Summary Tables (SECOND in a Two-Part Series)
Best Practices in SAS Statistical Programming for Regulatory Submission: Understanding and Applying the QC Plan to Validate Summary Tables (FIRST in a Two-Part Series)
Biopharmaceutical Process Systems
Biosafety of Biological Drug Products
Biostatistics for the Non-Statistician - Beyond the Basics
cGMP and Quality Issues for Biopharmaceuticals
cGTP in a Nutshell
Clinical Testing Submissions
Combination Products: How to Approach the Proposed Manufacturing and Distribution Requirements
Commissioning, Qualification and Validation
Complaint Systems - The Essential Requirements
Conducting Compliant Endotoxin Testing
Control of Microbial Contamination in Manufacture of Sterile and Non-Sterile Products
Crackdown on Institutional Review Boards (IRBs)
CSOs: Are They Right for You?
Current Good Tissue Practices (cGTPs)
Data Integrity: The Proof’s in the Inputting
Designing the "State of the Art" Laboratory
Developability Assessment
Developmental and Reproductive Toxicology
Downstream Processing in Biotechnology
Effective Clinical Data Acceptance Testing
Effective Tools in Selecting a CRO
Effectively Managing CROs
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals
Endotoxin Testing: Resolving Interference and Test Validation
Environmental Monitoring for Non-Sterile Drugs
FDA Quarterly Briefing: Focus on Biotechnology February, 2010
FDA Quarterly Briefing: Focus on Pharmaceuticals – January 2010
FDA Quarterly Briefing–April 2009
FDA Quarterly Briefing–January 2009
FDA Quarterly Briefing–July 2008
FDA Quarterly Briefing–July 2009
FDA Quarterly Briefing–October 2008
FDA Quarterly Briefing–October 2009
Fundamentals of Biochemistry: Background for Biotechnology
Fundamentals of Biotechnology
Fundamentals of Molecular Biology and Genetic Engineering
Fundamentals of Nanotechnology
Getting a Share of the BioDefense Grant Billions
GLP Study Director
Good Clinical Practices (GCP)
Good Distribution Practices
Good Laboratory Practices (GLP)
Guidelines for Skin Absorption Studies
ICH-Q7
Implementing GEP (Good Engineering Practices) in the Pharmaceutical, Bio-Pharmaceutical, and Medical Device Industries
Improving Drug Delivery Through the Use of Polymers
Industrial Membrane Separations
International Patent Law
Introduction to cGMP System-Based Audits
Introduction to Drug Delivery Technology
Investigation of Microbial Contamination in Sterile and Non-Sterile Products
Key PAT and QbD Concepts: Quality Systems Integration Strategies (QSIS)
Key PAT Concepts: Focus on Design of Experiment
Key PAT Concepts: Focus on Design Space
Key PAT Concepts: Focus on Desired State
Lyophilization 101: Principles, Physical Properties and Characterization Techniques
Lyophilization Technology
Lyophilization: Optimized Pre-Formulation, Formulation, and Cycle Development Techniques
Measurement Uncertainty in Analytical Chemistry
Meeting Today’s FDA Requirements for Clinical Trial Processes
Microbial Challenge and Shelf Life Testing for Foods
Microbiological Control and Validation
Mixing of Liquids and Complex Materials
Monitoring of Clinical Drug Studies
Non-Clinical Drug Safety Evaluation and Drug Development
Orphan Drug Application and Submission
Outsourcing Clinical Development
PAI: Surviving the Pre-Approval Inspection
PAT Online Process Analysis
PAT-Based Downstream Protein Purification
Patent Law
Pharma: Concept To Consumer
Pharmaceutical Process Validation Basics
Pharmaceutical Technology Transfer
Pharmaceutical Water and the International Regulatory Environment
Pharmaceutical Water Sampling and Testing
Pharmaceutical Water System–Design and Operation
Pharmaceutical Water Systems
Pharmaceutical Water Systems: Validation and Start-Up
Pharmaceutical Water: Chemistry, System Design and Validation
Practical Biostatistics for the Non-Statistician - The Basics
Principles of Contemporary Immunology
Proven Methods to Root Cause Analysis for CAPA
Qualification and Validation of Analytical Methods for Protein Products
Real World Approaches to PAT and QbD Implementation
Recognizing and Preventing Data Integrity Issues
Role of PAT and QbD in Biologic Drug Production
Role of Pharmaceutical QA/QC in Quality Systems
Root Cause Investigation for CAPA
Selecting a Drug Product Candidate Using Quality Risk Management: PAT & QbD
Statistical Process Control for PAT
Strategies for Leveraging PAT/QbD in Biologic Applications
Tactics to an Effective FDA Submission
The China Syndrome: Quality Issues in Manufacturing
The Coming Medical Device Revolution
Transdermal Drug Delivery
Writing and Implementing Clinical Protocols