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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
21 CFR Part 11: Strategies for Cost Effective Compliance Using a Risk-based Approach
A Survey of Microbiology for the Pharmaceutical, Biotechnology, and Medical Device Industries
Active Pharmaceutical Ingredients
ADME Fundamentals 
Advanced Tablet Press Operation 
Adverse Drug Event Monitoring and Reporting 
An Overview of Documentation Requirements in FDA Regulated Industries
An Overview of Process Validation for the Pharmaceutical, Medical Device and Related Industries
Analytical Methods Validation for FDA Compliance
Annual Product Reviews (APRs) For Pharmaceuticals 
Applied cGMPs for Pharmaceutical and Allied Industries 
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 cGMP Compliance 
Barrier/Isolater Technology for FDA Regulated Facilites 
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)
Biocidal and Plant Protection Products in the EU: Borderlines and Overlaps
Biopharmaceutical Process Systems 
Biostatistics for the Non-Statistician - Beyond the Basics 
Bringing Nanotechnology to Your Market
Calibration in the FDA Regulated Industry 
cGMP and Quality Issues for Biopharmaceuticals 
cGMP Auditing - Strategies for Compliance 
cGMP for Pharmaceutical Production Supervisors 
cGMP for Pharmaceutical Quality Control Laboratory Personnel 
cGMP Regulations for Pharmaceutical Corporate Executives 
cGTP in a Nutshell
Change Control/Deviation 
Choosing Sensors, Monitors and Instruments for PAT Programs
Clean Room Technology 
Clinical Testing Submissions
CMC Submissions in CTD Format
Combination Product Development: Safety/Registration/Approval 
Combination Products: How to Approach the Proposed Manufacturing and Distribution Requirements 
Commissioning, Qualification and Validation 
Complaint Systems - The Essential Requirements
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
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
Design Control and Product Validation
Designing the "State of the Art" Laboratory 
Developability Assessment 
Developing and Maintaining an Effective Complaint System
Developing Specifications for Drug Substances (APIs) and Drug Products 
Developmental and Reproductive Toxicology 
Documentation Management and Control
DQ: A Guide to Protecting Your Interests When Procuring Sensors
Drug Product Stability and Shelf-Life
Drug Regulatory Compliance/Drug Approval and Preapproval Inspection 
Effective Clinical Data Acceptance Testing
Effective Tools in Selecting a CRO 
Effectively Managing CROs
Effects of Psychological Factors and Stress on Skin Inflammatory Disorders
Encapsulation: Basic Techniques and Applications
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals 
Endotoxin Testing: Resolving Interference and Test Validation
Environmental Control and Monitoring 
Environmental Monitoring for Non-Sterile Drugs
Evolution of the Pharmaceutical Industry through 2020
Excipient GMPs 
Failure to Warn and Medical Device Preemption
Failure to Warn and Preemption 
FDA Drug Development and Compliance
FDA Quarterly Briefing: Focus on Biotechnology February, 2010 
FDA Quarterly Briefing: Focus on Medical Device News–December, 2009
FDA Quarterly Briefing: Focus on Medical Device News–March 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
Food Supplements, Additives and Herbal Medicines
Fragrance and the Mind
Fundamentals of Biotechnology 
Fundamentals of Nanotechnology 
Generic Drug Approvals
Globally Harmonized Systems (GHS) 
GLP Study Director 
GMP for Dietary Supplements 
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
Improving Drug Delivery Through the Use of Polymers 
INDs/NDAs/CTDs
Industrial Drying of Heat Sensitive Materials 
Industrial Membrane Separations 
Industrial Rheology 
Initiatives in the Cosmetic & Personal Care Industry
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 101: Principles, Physical Properties and Characterization Techniques
Lyophilization 101: Scale-Up, Cycle Transfer, and Sonic Water Vapor Flow
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
Microbiological Control and Validation 
Microencapsulation and Particle Coating 
Microwave and RF Technology 
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 
Nutritional Supplement Formulation Basics
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
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 Production and QA/QC Records and Reports 
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
Pharmaceutical Water: Chemistry, System Design and Validation
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 Validation for Packaging of Pharmaceuticals and Medical Devices 
Process Validation for the Pharmaceutical and Medical Device Industries 
Proven Methods to Root Cause Analysis for CAPA
Qualification and Validation of Analytical Methods for Protein Products 
Quality System 
REACH Alert: Current Rules, Guidance Documents and Implementation Status
Real World Approaches to PAT and QbD Implementation 
Recognizing and Preventing Data Integrity Issues
Registration of Pharmaceutical Products in the European Union 
Risk Management in a Nutshell 
Role of Pharmaceutical QA/QC in Quality Systems 
Root Cause Investigation for CAPA
Safety Assessment of Cosmetic Ingredients and Formulations–An Introduction
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 
Skin Inflammation – Reasons, Prevention, Treatment and Testing
Skin Inflammation: From Triggers to Aging 
Skin Product Development
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 Leveraging PAT/QbD in Biologic Applications
Sulfonation and Sulfation Technology 
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
Topical Antiseptic Product Development
Transdermal Drug Delivery
Understanding Pharma: Business Growth and Drivers
Updates on Process Validation for Medical Devices…New Approaches and Practice
USP Guidelines for Product Quality and Product Performance Tests
Validation and Certification of the Pharmaceutical Quality Control Laboratory 
Validation of Computer Systems: Pharmaceutical Manufacturing 
Validation of Manufacturing and Distribution Computer Systems 
Vendor and Contract Supplier Qualification 
Water Based Polymers 
Writing and Implementing Clinical Protocols  
Writing SOPs for cGMP Compliance 
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