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Pharmaceutical Training Courses on Validation and Regulatory Compliance from CfPA Pharmaceutical Technology
  

Pharmaceutical Training

WHY IS PHARMACEUTICAL TRAINING IMPORTANT?
Pharmaceutical training helps you to fill in the void between the curriculum of a theoretical education and the practical demands of adhering to pharmaceutical regulatory compliance and pharmaceutical validation processes.




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 pharmaceutical training courses. Online and public courses run one- to five- days in length and include discussions, case studies, and group exercises which are taught by top industry leaders who share their knowledge in an enthusiastic, interactive manner.


Pharmaceutical Validation | Pharmaceutical Regulatory Compliance


WHAT IS PHARMACEUTICAL VALIDATION?
As defined by FDA's 1987 Guideline on General Principles of Process Validation, validation - such as pharmaceutical validation - is "Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product, meeting its pre-determined specifications and quality attributes."

Validation is a requirement of Good Manufacturing Practices (GMP).

The following highlighted pharmaceutical training courses offered by CfPA focus on pharmaceutical validation:

WHAT IS PHARMACEUTICAL REGULATORY COMPLIANCE?
FDA ensures the quality of drug products by carefully monitoring if drug manufacturers adhere to pharmaceutical regulatory compliance per the Current Good Manufacturing Practices (cGMP). The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packaging of a drug product.  The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The following highlighted pharmaceutical training courses offered by CfPA focus on pharmaceutical regulatory compliance:


WHEN AND WHERE CAN I GET PHARMACEUTICAL TRAINING?

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


 

Course TitleScheduled
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
Acne: Biochemistry and Treatment
Active Pharmaceutical Ingredients 
Advanced Aqueous Film Coating
Advanced Tablet Press Operation
Adverse Drug Event Monitoring and Reporting 
Adverse Effects on Skin–How to Formulate a Safer Topically Applied Product 
Aerosol Technology
Agglomeration I: A Practical Approach to Particle Size Enlargement (First in a two-part series)
Agglomeration II: Tumble Agglomeration Basics (Second in a two-part series)
Agglomeration III: Press & Pressure Agglomeration Basics
An Introduction to Orphan Drug Submissions and Application
An Introduction to Pathways for Skin Penetration
An Overview of Documentation Requirements in FDA Regulated Industries
An Overview of Process Validation for the Pharmaceutical, Medical Device and Related Industries
Analytical and Product Target Profiles in QbD
Analytical Methods Validation for FDA Compliance 
Annual Product Reviews for the Pharmaceutical and Related Industries
Applied Project Management Fundamentals
Assuring Quality of Supplies to Pharmaceutical and Related Industries 
Assuring Your Supply Chain through Supplier Qualification
Auditing and Inspecting Preclinical Research for GLP Compliance 
Auditing for GMP Compliance
Automating GMPs: The GAMP
Barrier/Isolater Technology for FDA Regulated Facilites 
Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program
Basics of Skin Allergy and Newest Testing Methods
Batch Records: Simplified and Clarified
Beauty From Within: Fighting Skin Aging and Disorders Through Proper Nutrition
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 
Biostatistics for the Non-Statistician - Beyond the Basics 
Bringing Nanotechnology to Your Market
Building the eCTD for FDA Submission 
Calibration in the FDA Regulated Industry
CAPA: A Critical Quality System Requirement
cGMP and Quality Issues for Biopharmaceuticals 
cGMP Auditing - Strategies for Compliance 
cGMP for Pharmaceutical Quality Control Laboratory Personnel 
cGMP Regulations for Pharmaceutical Corporate Executives 
cGTP in a Nutshell
Change Control/Deviation 
Characterization of Proteins for Development and Approval of Protein Pharmaceuticals and Vaccines 
Chemical Engineering for Non-Chemical Engineers: Fundamentals
Choosing Sensors, Monitors and Instruments for PAT Programs
Clean Room Technology 
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 
CMC Writing and Submission Strategies: A Global Regulatory Approach
Combination Product Development: Safety/Registration/Approval 
Combination Products: How to Approach the Proposed Manufacturing and Distribution Requirements
Commissioning, Qualification and Validation 
Compare and Conquer SAS Programming Techniques for FDA Submissions
Conception, Design and Implementation of Plant Safety Systems 
Conducting Compliant Endotoxin Testing
Conducting Effective Quality Audits
Control of Microbial Contamination in Manufacture of Sterile and Non-Sterile Products
Cosmeceutical Products, Market and Claims
Cosmetic GMPs Around the World
Cosmetic Regulations Around the Globe: Focus on Asia
Cost Effective Quality-by-Design and Critical-to-Quality Tools for PAT
Crackdown on Institutional Review Boards (IRBs) 
Critical Process Cleaning and Cleaning Validation
CSOs: Are They Right for You?
Current EU Chemical Control Regulations, from REACH to the GHS–EU Focus
Current Good Manufacturing Practice (cGMP) for Purchasing 
Current Good Tissue Practices (cGTPs) 
Current Rules, Guidance Documents and Implementation Status for REACH–Fall 2009
Data Integrity: The Proof’s in the Inputting
Dermal Barriers to Infection
Desalination Technology Basics 
Design and Implement a Risk-Based Training (RBT) System
Design and Troubleshooting of the Granulated Product and Processes
Design Control and Product Validation
Designing the "State of the Art" Laboratory 
Developability Assessment 
Developing Specifications for Drug Substances and Drug Products
Developmental and Reproductive Toxicology 
Direct Drying and Dryer Operations
Do Nano-particles Penetrate the Skin?
Documentation Management and Control
DQ: A Guide to Protecting Your Interests When Procuring Sensors
Drug Delivery to Skin
Drug Product Stability and Shelf-Life
Drug Regulatory Compliance/Drug Approval and Preapproval Inspection 
Eczema and Psoriasis: Biochemistry and Treatment
Effective Clinical Data Acceptance Testing
Effective QbD (Quality by Design): A Second Generation Approach 
Effective Tools in Selecting a CRO 
Effectively Managing CROs
Effects of Psychological Factors and Stress on Skin Inflammatory Disorders
Efficient Nozzle Atomization
Efficient Wheel and Two-Fluid Atomization
Electronic Records: 21 CFR Part 11-Revisited
Encapsulation: Basic Techniques and Applications
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 Control and Monitoring 
Environmental Monitoring for Non-Sterile Drugs
Equipment Qualification 1.0
Essential Oils in Skin Product Formulation
Essentials on Entering the Chinese Cosmetic Market
Ethnic Skins and Skin-of-Color: Biological and Product Development Differences
EU’s Biocidal Product Directive (BPD) & The New Biocidal Product Regulation (BPR)
Evaporation and Evaporators-Part 1
Evaporation and Evaporators-Part 2
Evolution of the Pharmaceutical Industry through 2020
Excipient GMPs 
Failure to Warn and Medical Device Preemption
Failure to Warn and Preemption 
FDA Briefing–October 2011 
Filtration One: The Process, The Equipment, The Equations
Filtration Two: Expression, Media, Pretreatment, Operating Tips
Food Supplements, Additives and Herbal Medicines
Fragrance and the Mind
Fundamentals of Biotechnology
Fundamentals of Nanotechnology 
Gene Expression Studies for Skin Product Development: An Introduction to the Basics
Gene Expression Studies for Skin Product Development: Basics & Beyond 
Generic Drug Approvals
Global Cosmetic Regulations: Going Green
Global Counterfeiting: Alarming Facts and Defensive Business Strategies 
Global QA/QC for Biopharmaceuticals, Vaccines and Other Biologics 
Globally Harmonized Systems (GHS) 
GLP Study Director
GMP for Dietary Supplements 
GMPs In-Depth Analysis for Pharmaceutical Life Cycle Management
Good Clinical Practices (GCP) 
Good Distribution Practices 
Good Laboratory Practices (GLP)
Granulation, Tabletting and Capsule Technology
Guidelines for Skin Absorption Studies 
Guidelines to In Vitro Skin Absorption Studies
Gums and Hydrocolloids 
Heat Exchanger Design in an Energy Conscious World
History, Theory, and Instrumentation of Near-Infrared Spectroscopy
ICH Q10: Pharmaceutical Quality System 
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 
INDs/NDAs/CTDs
Industrial Application of Optimization
Industrial Drying of Heat Sensitive Materials 
Industrial Membrane Separations 
Industrial Mixing and Multiphase Processing Basics 
Instrumental Methods for Pharmaceutical Trace Metals Analysis
International Patent Law 
Introduction to cGMP System-Based Audits
Introduction to Drug Delivery Technology 
Introduction To Pharmaceutical cGMP
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
Keys to Risk Management: Implementation, Documentation, Monitoring and Mitigation
Labeling OTC Drugs 
Laboratory Control System
Lean Methodology: Eliminate Waste, Improve Efficiency, Increase Profits
Lyophilization Technology
Managing FDA Inspections: the FDA investigator cometh...are you ready?
Managing Multiple Projects Utilizing Lean Manufacturing Techniques
Managing the Quality of Laboratory Data: Implementing a Quality Management System
Measurement Uncertainty in Analytical Chemistry 
Meeting Today’s FDA Requirements for Clinical Trial Processes
Microbiological Control and Validation
Microbiology Fundamentals Relating to Clean Rooms (Second in a Three Part Series)
Microencapsulation and Particle Coating 
Microwave and RF Technology 
Mixing Basics: An Introduction to Mixing of Liquids and Complex Fluids for the Process Industries
Mixing of Liquids and Complex Materials 
Monitoring of Clinical Drug Studies 
Natural Ingredients in Formulating Skin Care Products
Non-Clinical Drug Safety Evaluation and Drug Development
Nutrition, Health & Cosmeceutical Claims: Focus on EU Regulations 
Nutrition, Health & Cosmeceutical Claims: Focus on US Regulations 
Nutritional Supplement Formulation Basics
Operation of the Clean Room (Third in a Three Part Series)
Optimizing Energy Use in Nuisance Dust Collection Applications 
Orphan Drug Application and Submission 
Outsourcing Clinical Development 
Outsourcing Pharmaceutical Operations
Overcoming the Challenges to Transdermal Drug Delivery Development–An Introduction
Packaging of Pharmaceuticals
PAI: Surviving the Pre-Approval Inspection
Particle Size Reduction I: General Aspects, Physics of Breakage, Shape, Size and Surface (First in a two-part series)
Particle Size Reduction II: Size Reduction Equipment, Equipment Operation, Energy Requirements (Second in a two-part series)
Paste and High Viscosity Processing
PAT Online Process Analysis 
Patent Law 
Pathways to Skin Penetration 
Pharma: Concept To Consumer 
Pharmaceutical Aerosol Technology 
Pharmaceutical cGMP-Quality Systems
Pharmaceutical Coating Technology 
Pharmaceutical Laboratory Information Management System (LIMS) 
Pharmaceutical Process Development
Pharmaceutical Process Validation Basics
Pharmaceutical Quality Assurance and Control
Pharmaceutical Risk Management Tools: Getting the Most Out of ICH Q9 
Pharmaceutical Supervisory Management Skills 
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
Photobiology, Phototoxicology and Sunscreen Standards
Pneumatic Conveying Theory/Calculations 
Powder Mixing Technology
Powders: Their Properties and Processing
Practical Biostatistics for the Non-Statistician - The Basics 
Practical Steps to Understanding ICH Q9 
Preparation, Packaging and Labeling of Clinical Trial Materials
Preparing for and Surviving an FDA Inspection
Preservatives and Biocides in Consumer Products
Principles of Contemporary Immunology 
Process Improvement Using Parallel Coordinate Geometry 
Process Validation for Packaging of Pharmaceuticals and Medical Devices 
Process Validation for the Pharmaceutical and Medical Device Industries 
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)
Quality System 
REACH Alert: Current Rules, Guidance Documents and Implementation Status
REACH: EU’s Chemical Policy Review & Compliance Guide: Five Years Later 
Real World Approaches to PAT and QbD Implementation 
Registration of Pharmaceutical Products in the European Union 
Rheology of Dispersions
Risk Hazard Assessment for Validation– ISO14971, HACCP, FMEA, FAULT TREE
Risk Management in a Nutshell 
Risk-Based Training: An Introduction
Role of Pharmaceutical QA/QC in Quality Systems 
Root Cause Investigation for CAPA
Safety Assessment and Biocompatibility Evaluation
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Selecting a Drug Product Candidate Using Quality Risk Management: PAT & QbD
Selecting and Managing CROs
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)
Skin Inflammation – Reasons, Prevention, Treatment and Testing
Skin Inflammation: From Triggers to Aging 
Skin Lightening Product Development: From Biochemistry to Applications
Skin Moisturization & Moisturizing Products: Where is water in the skin?
Skin Product Adverse Effects: Causes and Prevention
Skin Product Development
Skin Toxicology: Alternative Methods for Skin Safety Assessment
Skin Toxicology: Cytotoxicity Testing
Skin Toxicology: Introduction to Skin Toxicology
Skin Toxicology: Skin Sensitization Basics and Newest Testing Methods
Skin Toxicology: Testing for Skin Irritation–Basics and Alternatives
Spray Drying: Practical Design and Operation-Part 1
Spray Drying: Practical Design and Operation-Part 2
Starch: Chemistry, Properties and Applications
Statistical Process Control for PAT 
Sterile Products: Formulation, Manufacture and Quality Assurance
Sterilization in the Pharmaceutical Industry 
Sterilization Technologies and Process Validation 
Strategies for 21 CFR Part 11 Cost Effective Compliance Using a Risk-based Approach
Strategies for Leveraging PAT/QbD in Biologic Applications
Sulfonation and Sulfation Technology 
Sunlight Exposure to the Skin: Can We Shield the Bad and Enhance the Good?
Surfactants, Colloids and Interfaces
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
Suspensions and Emulsions in Pharmaceuticals and Food
System Validation, GAMP Harmonization and P.A.T 
System Validation, GAMP Harmonization and P.A.T  
Tablet Production for Operators and Supervisors
Tactics to an Effective FDA Submission
Testing for Photo-Toxicity: Compliance with REACH and the 7th Amendment
The China Syndrome: Quality Issues in Manufacturing
The Coming Medical Device Revolution
The Do’s, Don’ts, and Whys of HPLC
The Essentials of U.S. Drug Labeling and Advertising Laws
The Harmful Effects of Visible Light to Skin: Gene Expression Insights
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 Use of Naturals in Skin Product Development: Focus on Ayurveda and Chinese Herbs
The Validation of Computer Systems and 21 CFR Part 11 
Topical Antiseptic Product Development
Transdermal Drug Delivery 
U.S. FDA Drug Development and Compliance
Understanding Pharma: Business Growth and Drivers
Understanding the Mechanisms of Cell Death–Health, Disease and Aging
Updates on Process Validation for Medical Devices…New Approaches and Practice
Using ICH Guidelines to Re-enforce Your GMP Compliance 
USP Guidelines for Product Quality and Product Performance Tests
Validating Multiple Response Variables
Validation and Certification of the Pharmaceutical Quality Control Laboratory 
Validation of Manufacturing and Distribution Computer Systems 
Vendor and Contract Supplier Qualification 
Water Based Polymers 
What Engineering Thermoplastic is Right for Your Application? 
What is the Pharma Quality System and Why Should I Care?
Wound Repair and Tissue Healing Through Inflammation
Writing and Implementing Clinical Protocols  
Writing SOPs for cGMP Compliance 
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