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INHOUSE TRAINING

Medical Devices / Diagnostics

•   Analytical Methods Validation for FDA Compliance

•   Calibration in the FDA Regulated Industry

•   Clean Room Technology

•   Complaint Procedures for Medical Device

•   Critical Process Cleaning and Cleaning Validation

•   Current Good Manufacturing Practice (cGMP) for Purchasing

•   Design Control and Product Validation

•   Equipment Qualification in a Nutshell

•   Fundamentals of Nanotechnology

•   Good Distribution Practices

•   International Patent Law

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

•   Lyophilization Technology

•   Microbiological Control and Validation

•   Near Infra-Red Spectroscopy

•   Pharmaceutical cGMPs and FDA Inspections

•   Pharmaceutical Water Systems

•   Risk Analysis & Human Factors Engineering

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

•   Vendor and Contract Supplier Qualification

•   Active Pharmaceutical Ingredients Production

•   Calibration in the FDA Regulated Industry

•   cGMP Auditing - Strategies for Compliance

•   cGMP for Pharmaceutical Production Supervisors

•   Combination Product Development: Safety/Registration/Approval

•   Complaint Procedures for Medical Devices

•   Complaint Systems-The Essential Requirements

•   Conducting Effective Quality Audits

•   Critical Process Cleaning and Cleaning Validation

•   Current Good Manufacturing Practice (cGMP) for Purchasing

•   Design Control and Product Validation

•   Documentation Management and Control

•   Early Stage Clinical Studies for Drugs and Devices

•   Equipment Qualification in a Nutshell

•   Fundamentals of Biochemistry: Background for Biotechnology

•   IQ, OQ, PQ

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

•   Lyophilization Technology

•   Microbiological Control and Validation

•   Patent Law for Managers, Engineers and Scientists

•   Pharmaceutical cGMPs and FDA Inspections

•   Preparing for and Surviving an FDA Inspection

•   Process Validation for Packaging of Pharmaceuticals and Medical Devices

•   Risk Based Approach to Integrated Commissioning, Qualification and Validation

•   Root Cause Investigation for CAPA

•   The Quality System

•   Writing SOPs for cGMP Compliance

•   Active Pharmaceutical Ingredients Production

•   Analytical Methods Validation for FDA Compliance

•   Biocompatibility Evaluation for Registration of Medical Devices and Biomaterials

•   Calibration in the FDA Regulated Industry

•   CAPA - The Heart of Your Quality System: An Online Training Course

•   cGMP Auditing - Strategies for Compliance

•   cGMP for Pharmaceutical Production Supervisors

•   Clean Room Technology

•   Clinical Studies for Medical Devices

•   Combination Product Development: Safety/Registration/Approval

•   Complaint Procedures for Medical Devices

•   Complaint Systems-The Essential Requirements

•   Concepts of Medical Device Packaging

•   Conducting Effective Quality Audits

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

•   Critical Process Cleaning and Cleaning Validation

•   Current Good Manufacturing Practice (cGMP) for Purchasing

•   Current Good Tissue Practice

•   Design Control and Product Validation

•   Documentation Management and Control

•   Early Stage Clinical Studies for Drugs and Devices

•   Environmental Control and Monitoring

•   Equipment Qualification in a Nutshell

•   Fundamentals of Biochemistry: Background for Biotechnology

•   Fundamentals of Nanotechnology

•   GMP/QSR/QSIT for Medical Devices

•   Good Distribution Practices

•   International Patent Law

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

•   LAL Testing: Drugs, Medical Devices and Biopharmaceuticals

•   Lyophilization Technology

•   Medical Device Regulatory Compliance

•   Medical Devices: Strategies for Getting To & Staying on the Market

•   Microbiological Control and Validation

•   Near Infra-Red Spectroscopy

•   Patent Law for Managers, Engineers and Scientists

•   Pharmaceutical cGMPs and FDA Inspections

•   Pharmaceutical Water Systems

•   Premarket Submissions for Software Controlled Medical Devices

•   Preparing for and Surviving an FDA Inspection

•   Process Validation for Packaging of Pharmaceuticals and Medical Devices

•   Process Validation for the Pharmaceutical and Medical Device Industry

•   Registration of Medical Devices and In Vitro Diagnostics in Europe

•   Risk Analysis & Human Factors Engineering

•   Risk Based Approach to Integrated Commissioning, Qualification and Validation

•   Selecting & Managing CRO's

•   Selecting a Drug Product Candidate for PAT: An Online Training Course

•   Sterilization Technology and Process Validation

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

•   Technical Writing in Pharmaceutical and Allied Industries

•   The Quality System

•   U.S. FDA Regulatory Compliance

•   Validating Medical Devices: Computer Software and Hardware

•   Vendor and Contract Supplier Qualification

•   Writing SOPs for cGMP Compliance

•   Writing When English is Your Second Language

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