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INHOUSE TRAINING

 

Pharmaceutical Technology

•   ADME: Fundamentals of Absorption, Distribution, Metabolism and Elimination

•   Analytical Methods Validation for FDA Compliance

•   Auditing for cGMP Compliance

•   Calibration in the FDA Regulated Industry

•   Choosing Sensors, Monitors and Instruments for PAT Programs

•   Clean Room Technology

•   CMC Submissions in CTD Format

•   Complaint Procedures for Medical Devices

•   Complaint Systems-The Essential Requirements

•   Cosmetic Product Formulation

•   Critical Process Cleaning and Cleaning Validation

•   Current Good Manufacturing Practice (cGMP) for Purchasing

•   Design Control and Product Validation

•   Drug Product Stability and Shelf-Life

•   Drug Specifications for APIs and Drug Products

•   Effective Project Management

•   Emulsion-Suspension Technology

•   Equipment Qualification in a Nutshell

•   Excipient GMPs

•   Fundamentals of Nanotechnology

•   Good Distribution Practices

•   Good Laboratory Practices (GLP)

•   Granulation, Tabletting and Capsule Technology

•   Hair Product Development

•   ICH Q10: Pharmaceutical Quality System

•   Industrial Membrane Separations

•   Industrial Rheology

•   International Patent Law

•   Introduction to Drug Delivery Technology

•   ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies

•   Laboratory Control Systems

•   Lyophilization Technology

•   Microbiological Control and Validation

•   Microencapsulation and Particle Coating

•   Near Infra-Red Spectroscopy

•   Non-Clinical Drug Safety Evaluation and Drug Development

•   Packaging of Pharmaceuticals

•   PAT Online Process Analysis

•   PAT-Based Downstream Protein Purification

•   Pharmaceutical cGMPs and FDA Inspections

•   Pharmaceutical Process Development

•   Pharmaceutical Water Systems

•   Powder Mixing Technology

•   Process Analytical Technology

•   Risk Analysis & Human Factors Engineering

•   Risk Based Approach to Integrated Commissioning, Qualification and Validation

•   Skin Product Development

•   Sterilization in the Pharmaceutical Industry

•   Surfactants, Colloids and Interfaces

•   Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites

•   System Validation, GAMP Harmonization and P.A.T

•   Vendor and Contract Supplier Qualification

•   Active Pharmaceutical Ingredients Production

•   Aerosol Technology

•   Analytical Methods Validation for FDA Compliance

•   Atomization, Sprays and Atomizers

•   Auditing and Inspecting Preclinical Research for GLP Compliance

•   Calibration in the FDA Regulated Industry

•   cGMP Auditing - Strategies for Compliance

•   cGMP for Pharmaceutical Production Supervisors

•   Choosing Sensors, Monitors and Instruments for PAT Programs

•   CMC Submissions in CTD Format

•   Combination Product Development: Safety/Registration/Approval

•   Complaint Procedures for Medical Devices

•   Complaint Systems-The Essential Requirements

•   Conducting Effective Quality Audits

•   Cosmetic Product Formulation

•   Critical Process Cleaning and Cleaning Validation

•   Current Good Manufacturing Practice (cGMP) for Purchasing

•   Design Control and Product Validation

•   Documentation Management and Control

•   Drug Product Stability and Shelf-Life

•   Drug Specifications for APIs and Drug Products

•   Early Stage Clinical Studies for Drugs and Devices

•   Emulsion-Suspension Technology

•   Equipment Qualification in a Nutshell

•   Excipient GMPs

•   Flavors -- Their Creation, Definitions and Use

•   Fundamentals of Biochemistry: Background for Biotechnology

•   Fundamentals of Molecular Biology and Genetic Engineering

•   Generic Drug Approvals

•   GMP for Dietary Supplements

•   Good Clinical Practices (GCP)

•   Good Laboratory Practices (GLP)

•   Granulation, Tabletting and Capsule Technology

•   Gums and Hydrocolloids

•   Hair Product Development

•   ICH Q10: Pharmaceutical Quality System

•   ICH-Q7A

•   INDs, NDAs vs CTDs Global Regulations

•   Industrial Rheology

•   Ingredients for Cosmetics and Toiletries

•   Introduction to Drug Delivery Technology

•   IQ, OQ, PQ

•   ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies

•   Laboratory Analysis in Clinical Trials

•   Laboratory Control Systems

•   Lyophilization Technology

•   Microbiological Control and Validation

•   Microbiological Quality of Water-Based Consumer Products

•   Microencapsulation and Particle Coating

•   Mixing of Liquids and Complex Materials

•   Non-Clinical Drug Safety Evaluation and Drug Development

•   Packaging of Pharmaceuticals

•   PAT-Based Downstream Protein Purification

•   Patent Law for Managers, Engineers and Scientists

•   Pharmaceutical cGMPs and FDA Inspections

•   Pharmaceutical Process Development

•   Pharmaceutical Quality Assurance and Control

•   Pharmaceutical Supervisory Management Skills

•   Pharmaceutical Technology Transfer

•   Pilot Plant and Scale-up Studies

•   Powder Mixing Technology

•   Preparation, Packaging and Labeling of Clinical Trial Materials

•   Preparing for and Surviving an FDA Inspection

•   Process Analytical Technology

•   Process Validation for Packaging of Pharmaceuticals and Medical Devices

•   Regulatory Compliance for the Personal Care Products Industry

•   Root Cause Investigation for CAPA

•   Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)

•   Skin Product Development

•   Sulfonation and Sulfation Technology

•   Surfactants, Colloids and Interfaces

•   Tablet Production for Operators and Supervisors

•   The Quality System

•   Writing and Implementing Clinical Protocols

•   Writing SOPs for cGMP Compliance

•   Active Pharmaceutical Ingredients Production

•   ADME: Fundamentals of Absorption, Distribution, Metabolism and Elimination

•   Adverse Drug Event: Monitoring and Reporting

•   Aerosol Technology

•   Analytical Methods Validation for FDA Compliance

•   Annual Product Reviews For Pharmaceuticals

•   Assay Development and Validation for Biopharmaceuticals

•   Atomization, Sprays and Atomizers

•   Auditing and Inspecting Clinical Research in the Global Environment

•   Auditing and Inspecting Preclinical Research for GLP Compliance

•   Auditing for cGMP Compliance

•   Barrier/Isolater Technology for FDA Regulated Facilites

•   Biopharmaceutical Process Systems

•   Biosafety of Biological Drug Products

•   Biostatistics for the Non-Statistician - Basic

•   Biostatistics for the Non-Statistician - Beyond the Basics

•   Calibration in the FDA Regulated Industry

•   CAPA - The Heart of Your Quality System

•   Case Report Forms and Other instruments for Clinical Data Collection

•   cGMP and Quality Issues for Biopharmaceuticals

•   cGMP Auditing - Strategies for Compliance

•   cGMP for Pharmaceutical Production Supervisors

•   cGMP for Pharmaceutical Q/C Laboratory Personnel

•   cGMP Inspections

•   Change Control/Deviation

•   Choosing Sensors, Monitors and Instruments for PAT Programs

•   Clean Room Technology

•   Clinical Data Management in Pharmaceutical Research and Development

•   Clinical Studies for Medical Devices

•   CMC Submissions in CTD Format

•   Combination Product Development: Safety/Registration/Approval

•   Complaint Procedures for Medical Devices

•   Complaint Systems-The Essential Requirements

•   Computer-Assisted Chemistry in Drug Design

•   Conducting Effective Quality Audits

•   Cosmetic Product Formulation

•   Cost Effective Quality-by-Design and Critical-to-Quality Tools for PAT

•   Critical Cleaning and Microbial Control for Barrier Tech. and Adv. Aseptic Processing

•   Critical Process Cleaning and Cleaning Validation

•   Current Good Manufacturing Practice (cGMP) for Purchasing

•   (cGMP) Regulations for Human Resources Personnel

•   (cGMP) Regulations for Pharmaceutical Corporate Executives

•   Current Good Tissue Practice

•   Design Control and Product Validation

•   Designing the "State of the Art" Laboratory

•   Developability Assessment

•   Developmental and Reproductive Toxicology

•   Documentation Management and Control

•   Drug Product Stability and Shelf-Life

•   Drug Regulatory Compliance - Approval & Preapproval Inspections

•   Drug Specifications for APIs and Drug Products

•   Dust Collection System Design, Troubleshooting and Optimization

•   Early Stage Clinical Studies for Drugs and Devices

•   Effective Project Management

•   Emulsion-Suspension Technology

•   Environmental Control and Monitoring

•   Equipment Qualification in a Nutshell

•   EU Regulations, Label and Leaflet Technology for Pharmaceutical Packaging

•   Excipient GMPs

•   Flavors -- Their Creation, Definitions and Use

•   Formulation, Analysis and Dosing of Preclinical Materials

•   Fragrances for Cosmetic and Household Products

•   Fundamentals of Biochemistry: Background for Biotechnology

•   Fundamentals of Molecular Biology and Genetic Engineering

•   Fundamentals of Nanotechnology

•   Generic Drug Approvals

•   Global Clinical Development

•   GMP for Dietary Supplements

•   GMP/QSR/QSIT for Medical Devices

•   Good Clinical Practices (GCP)

•   Good Distribution Practices

•   Good Laboratory Practices (GLP)

•   Granulation, Tabletting and Capsule Technology

•   Gums and Hydrocolloids

•   Hair Product Development

•   High Performance Liquid Chromatography I: Fundamentals, Equipment, and Operation

•   High Performance Liquid Chromatography II: Advanced Topics and Bio-Separations

•   ICH Q10: Pharmaceutical Quality System

•   ICH-Q7A

•   INDs, NDAs vs CTDs Global Regulations

•   Industrial Membrane Separations

•   Industrial Rheology

•   Ingredients for Cosmetics and Toiletries

•   Intellectual Property, Antitrust, Ethics and Licensing Laws

•   International Comparative Drug Regulatory Systems

•   International Patent Law

•   Introduction to Drug Delivery Technology

•   Introduction to Regulatory Affairs

•   Introduction to Skin Aging

•   ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies

•   Labeling Over The Counter Drugs

•   Laboratory Analysis in Clinical Trials

•   Laboratory Control Systems

•   LAL Testing: Drugs, Medical Devices and Biopharmaceuticals

•   Lyophilization Technology

•   Machinery Failure Analysis and Prevention

•   Medical Device Regulatory Compliance

•   Microbiological Control and Validation

•   Microbiological Quality of Water-Based Consumer Products

•   Microencapsulation and Particle Coating

•   Mixing of Liquids and Complex Materials

•   Monitoring of Clinical Drug and Biologics Studies

•   Near Infra-Red Spectroscopy

•   Non-Clinical Drug Safety Evaluation and Drug Development

•   Optimizing Phase I Clinical Trials

•   Outsourcing Clinical Development

•   Outsourcing Pharmaceutical Operations

•   Packaging of Pharmaceuticals

•   PAT Online Process Analysis

•   PAT-Based Downstream Protein Purification

•   Patent Law for Managers, Engineers and Scientists

•   peptide and Protein Drug Delivery

•   Pharma: Concept To Consumer

•   Pharmaceutical Aerosol Technology

•   Pharmaceutical cGMPs and FDA Inspections

•   Pharmaceutical Coating Technology

•   Pharmaceutical Laboratory Information Management System

•   Pharmaceutical Process Development

•   Pharmaceutical Production and QA/QC Records and Reports

•   Pharmaceutical Production Facilities

•   Pharmaceutical Quality Assurance and Control

•   Pharmaceutical Supervisory Management Skills

•   Pharmaceutical Technology Transfer

•   Pharmaceutical Water Systems

•   Phase I Drug Development

•   Powder Mixing Technology

•   Powders: Their Properties and Processing

•   Practical Problem Solving in Chemical Analysis

•   Preparation, Packaging and Labeling of Clinical Trial Materials

•   Preparing for and Surviving an FDA Inspection

•   Prescription and OTC Drug Advertising and Labeling

•   Principles of Contemporary Immunology

•   Principles of Process Validation

•   Process Analytical Technology

•   Process Plant Start-Up

•   Process Validation for Packaging of Pharmaceuticals and Medical Devices

•   Process Validation for the Pharmaceutical and Medical Device Industry

•   Procuring Clinical Drug Development Services

•   Quality Assurance for the Analytical Laboratory

•   Registration of Pharmaceutical Products in the European Union

•   Regulation of Traditional Foods, Functional Foods and Dietary Supplements

•   Regulatory Compliance for the Personal Care Products Industry

•   Risk Analysis & Human Factors Engineering

•   Risk Based Approach to Integrated Commissioning, Qualification and Validation

•   Root Cause Investigation for CAPA

•   Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)

•   Selecting & Managing CRO's

•   Selecting a Drug Product Candidate for PAT

•   Skin Product Development

•   Statistical Analysis of Laboratory Data

•   Statistical Process Control for PAT

•   Statistical Process Control: Basics and Advanced Topics

•   Sterile Products: Formulation, Manufacture and Control

•   Sterilization in the Pharmaceutical Industry

•   Sterilization Technology and Process Validation

•   Sulfonation and Sulfation Technology

•   Sunscreens: Chemistry, Formulation and Regulatory Considerations

•   Surfactants, Colloids and Interfaces

•   Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites

•   System Validation, GAMP Harmonization and P.A.T

•   Tablet Production for Operators and Supervisors

•   Tablets From Concept to Consumer: for Sales, Marketing and Supply Professionals

•   Technical Writing in Pharmaceutical and Allied Industries

•   Technical Writing in the Pharmaceutical and Allied Industries

•   The Quality System

•   U.S. FDA Regulatory Compliance

•   Validation and Certification of the Pharmaceutical Quality Control Laboratory

•   Validation of Computer Systems: Direct to You Technical Training

•   Validation of Manufacturing and Distribution Computer Systems

•   Validation of Non-Sterile Pharmaceutical Processes

•   Validation Planning and Execution for Regulatory Compliance

•   Validation Workshop for Computer Systems

•   Vendor and Contract Supplier Qualification

•   Water Based Polymers

•   Writing and Implementing Clinical Protocols

•   Writing SOPs for cGMP Compliance

•   Writing When English is Your Second Language

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