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 Writing and Submission Strategies: A Global Regulatory Approach - 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.
- 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 Risk Based Approach to Computer Systems Validation
A Survey of Microbiology for the Pharmaceutical, Biotechnology, and Medical Device Industries
Achieving Quality Assurance and Control in a Globalizing Industry
Advanced Aqueous Film Coating
Adverse Effects on Skin–How to Formulate a Safer Topically Applied Product
An Introduction to Orphan Drug Submissions and Application
An Overview of Documentation Requirements in FDA Regulated Industries
Analytical and Product Target Profiles in QbD
Annual Product Reviews for the Pharmaceutical and Related Industries
Assuring Quality of Supplies to Pharmaceutical and Related Industries
Auditing and Inspecting Preclinical Research for GLP Compliance
Auditing for GMP Compliance
Automating GMPs: The GAMP
Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program
Batch Records: Simplified and Clarified
Best Practices in Being “On-Call” for FDA Submission Audits
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
Building the eCTD for FDA Submission
CAPA: A Critical Quality System Requirement
cGMP and Quality Issues for Biopharmaceuticals
cGTP in a Nutshell
Characterization of Proteins for Development and Approval of Protein Pharmaceuticals and Vaccines
Chemical Engineering for Non-Chemical Engineers: Fundamentals
Clean Room Technology Basics in a Nutshell (First in a Three Part Series)
Clinical Testing Submissions
Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation
Combination Products: How to Approach the Proposed Manufacturing and Distribution Requirements
Commissioning, Qualification and Validation
Compare and Conquer SAS Programming Techniques for FDA Submissions
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
Do Nano-particles Penetrate the Skin?
Downstream Processing in Biotechnology
Drug Delivery to Skin
Effective Clinical Data Acceptance Testing
Effective QbD (Quality by Design): A Second Generation Approach
Effective Tools in Selecting a CRO
Effectively Managing CROs
Efficient Nozzle Atomization
Efficient Wheel and Two-Fluid Atomization
Electronic Records: 21 CFR Part 11-Revisited
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals
Endotoxin Testing: Resolving Interference and Test Validation
Enhancing and Defining Analytical Testing using QbD (Quality by Design)
Ensuring Data Integrity: A Multi-Disciplinary Approach
Environmental Monitoring for Non-Sterile Drugs
Equipment Qualification 1.0
FDA Briefing–October 2011
Filtration One: The Process, The Equipment, The Equations
Filtration Two: Expression, Media, Pretreatment, Operating Tips
Fundamentals of Biochemistry: Background for Biotechnology
Fundamentals of Biotechnology
Fundamentals of Molecular Biology and Genetic Engineering
Fundamentals of Nanotechnology
Gene Expression Studies for Skin Product Development: Basics & Beyond
Getting a Share of the BioDefense Grant Billions
Global Counterfeiting: Alarming Facts and Defensive Business Strategies
Global QA/QC for Biopharmaceuticals, Vaccines and Other Biologics
GLP Study Director
GMPs In-Depth Analysis for Pharmaceutical Life Cycle Management
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
Implementing Supplier Audits
Improving Drug Delivery Through the Use of Polymers
Industrial Application of Optimization
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
IQ, OQ, PQ
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 Technology
Managing FDA Inspections: the FDA investigator cometh...are you ready?
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
Microbiology Fundamentals Relating to Clean Rooms (Second in a Three Part Series)
Mixing of Liquids and Complex Materials
Monitoring of Clinical Drug Studies
Non-Clinical Drug Safety Evaluation and Drug Development
Operation of the Clean Room (Third in a Three Part Series)
Orphan Drug Application and Submission
Outsourcing Clinical Development
Outsourcing Pharmaceutical Operations
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
Pharmacokinetics—ADME Fundamentals
Practical Biostatistics for the Non-Statistician - The Basics
Principles of Contemporary Immunology
Protein Characterization Essentials
Proven Methods to Root Cause Analysis for CAPA
QbD Beyond Concepts: A Practical Implementation Plan
Qualification and Validation of Analytical Methods for Protein Products
Qualification/Validation for Bacterial Endotoxin Testing (BET)
Real World Approaches to PAT and QbD Implementation
Risk-Based Training: An Introduction
Role of PAT and QbD in Biologic Drug Production
Role of Pharmaceutical QA/QC in Quality Systems
Root Cause Investigation for CAPA
Safety Assessment and Biocompatibility Evaluation
Safety Assessment of Cosmetic Ingredients and Formulations: The Basics
Selecting a Drug Product Candidate Using Quality Risk Management: PAT & QbD
Setting up and Implementing Vendor and Supplier Audits
Skin Aging and Gene Expression
Skin Barriers, Penetration and Compound Interaction
Skin Barriers, Penetration and Compound Interaction
Skin Biochemistry Basics (First in a 3-Part Series)
Skin Biochemistry Basics (Second in a 3-Part Series)
Skin Biochemistry Basics (Third in a 3-Part Series)
Statistical Process Control for PAT
Strategies for Leveraging PAT/QbD in Biologic Applications
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
Tactics to an Effective FDA Submission
The China Syndrome: Quality Issues in Manufacturing
The Coming Medical Device Revolution
The Essentials of U.S. Drug Labeling and Advertising Laws
The Nuts and Bolts of U.S. Drug Labeling Requirements
The Pharmaceutical Supply Chain: Good Distribution Practices
The QbD Toolbox: Resources That Help New QbD Programs
The Validation of Computer Systems and 21 CFR Part 11
Transdermal Drug Delivery
Using ICH Guidelines to Re-enforce Your GMP Compliance
Writing and Implementing Clinical Protocols