· Home
o A Comprehensive View of Medical Device Post-Market Regulations and Challenges During
o 3 Days Virtual Seminar on Advanced Pharmacovigilance Auditing and Inspections
o 3 Days Virtual Seminar on Advanced Pharmacovigilance Auditing and Inspections
o Computer System Validation Professional Certification Program 3 Days
o Computer System Validation Professional Certification Program 3 Days
o FDA Computer System Validation ( CSV)
o The Healthcare Quality Improvement Act
o Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment
o Excel Spreadsheets - Develop and Validate
o Analytical Method Validation and Transfer According to the New FDA Guidance Training
o DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
Establishing a Robust Data Integrity Program
o Deviation Management – Why have we not solved the problem? Live Webinar
o 21 CFR Part 11 and Annex 11; how to increase productivity and reduce risk Live Webinar
o 2-Day Instructor-led Virtual Seminar FDA Inspection Essentials in 2021
o 2-Day Instructor-led Virtual Seminar FDA Inspection Essentials in 2021
o Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines? Live Webinar
o Fundamentals of Good Manufacturing Practices (GMP): Developing a Compliance Mindset Webinar
o Human Error Certification Training Program Training
o Managing Risk Within Your Supplier Management Program Live Webinar
o Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs) Webinar
o FDA CDS Software Regulation:The Latest Guidance on Clinical Decision Support Software Training
o Pharmaceutical Compressed Air - Quality GMP Requirements
o The Microbiology of Water in a GMP Environment
o Webinar How to write SOP's that Avoid Human Error
o Live Webinar Building a Compliant Laboratory
o Biostatistics for the Non-Statistician
o Quality Systems Inspection Technique (QSIT)
o Lifecycle Management of Analytical Methods and Procedures
o The Veterinary Drug Approval Process and FDA Regulatory Oversight Training
o The Veterinary Drug Approval Process and FDA Regulatory Oversight Training
o Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course
o Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements
o Root Cause Analysis Techniques and CAPA Management Live Webinar
o The Drug Development Process from Concept to Market
3 Day Web Seminar Understanding Medical Device Design Controls What, Why, and How
o Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products
o 21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures Live Webinar
o What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections Live Webinar
o FDA’s Regulation of OTC Drug Products
o Basic GMP Training for the QC Laboratory
o FDA Recalls - Before You Start, and After You Finish 2 Day Seminar
o FDA Recalls - Before You Start, and After You Finish 2 Day Seminar
Statistics for Process Control
o 6 hr Virtual Seminar Statistics for Process Control
o Hypothesis Testing, p-values,and Inference
o Aseptic Process Validation : Critical for compliance and success Virtual Training
o A Comprehensive View of Medical Device Post
o Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
o Process Validation Guidance Requirements (FDA and EU Annex 15
o Best Practices for Deviation Training
o Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries Live Webinar
o Compliant Management Controls Under 21 CFR 820 and ISO 13485
o Vaccine Patents in the Current Pandemic Climate
o FDA’s Plan for Modernizing the 510(k) Pathway Webinar
o Purchasing Controls, Receiving Inspection, and Supplier Audit
o Supervising a Human Error Free Environment You can do a Lot More than you Think Live Webinar
o Is My Data Abnormal? Normality Tests and Transformations
o Post-Market Activities in the EU-MDR
o Non-conforming Materials in a Medical Device Company
o Are you ready for your next regulatory inspection? On site or virtual in 2021 - Live Webinar
o Learn the Latest FDA Compliance and Mobile Applications Live Webinar
o Cosmetic Ingredients: from Science to Practical Use
o From MDD to MDR: Full Training Suite Package
o Creating and Maintaining an Effective and Efficient Technical Training Program 2021
o Continuing to Audit during a Global Pandemic
o Sterile Filtration of Pharmaceutical Products
o The European PSMF Live Webinar
o How FDA Trains Its Investigators to Review CAPA, and What You Should Do to Prepare
o Knock, knock, who’s there? Are you ready for an FDA inspection in the COVID-19 Era and Beyond?
o Live Webinar Sunscreens: Their Importance and US Regulations
o FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
o FDA's current thinking on Medical Device Cybersecurity in 2021
o From MDD to MDR: Full Training Suite Package
o Overview of Pharmacovigilance Under COVID-19 Live Webinar
o Raw Material Requirements (Health Canada/USP/EP)
o 3 hrs Webinar DHF, DMR, DHR, Technical Documentation and the EU's MDR Requirements
o Learn the latest Risk-Based Approach to CSV
o Investigating Out-of-Specification (OOS)
o A Culture of Quality is a Competitive Advantage Live Webinar
o Understanding the Design Verification and Validation Requirements for Medical Devices Webinar
o Live Webinar FDA Regulation of Artificial Intelligence/ Machine Learning
o Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
o Managing Compliance during the Pandemic Webinar
o Batch Record Review and Product Release Training
o NEW FDA Proposed FSMA Rule on Food Traceability During COVID19
o Properly Managing CAPA Programs for Successful Implementation
o Clinical Data Management Training
o Quality Control Laboratory Compliance
o Rouge Monitoring - The usage of science
o FDA Warnings - common trends and observations
o Learn the Latest FDA’s Regulatory Management of Your Cybersecurity Threats
o Cybersecurity, Data Integrity, Part 11, and Required Software Validation Training
o 7 secrets about Understanding the Design
o 7 secrets about Managing Your FDA Inspection’s 483 Observations Webinar
o 10 facts about Secrets for Writing Excellent SOPs for Medical Device QMS Live Webinar
o Data Integrity and Data Governance for Computer Systems Regulated by FDA
o Patient Access of PHI and Communications
o Best Practices To Help You Pass An FDA Computer System Validation Audit Training
o 10 Facts about Detailed Investigations
o Live Webinar How to Implement a Compliant Training Program and Reduce Human Error
o What You Need to Know IEC 62304 and Demystifying Software Validation using the Principles of LDLC
o FDA’s Technology Modernization Action Plan
o Understanding Quality Control Testing Webinar
o Computer System Validation (CSV) and Software Testing
o Annex 1 and its Comparison to Critical Utilities Compendial mandates
o 7 secrets about Technical Writing for the Pharmaceutical Industry Live Webinar
o FDA’s Ambitious Regulation of Social Media
o Data Integrity Practices for the Laboratory and Beyond
o What You Need to Know: Auditing EU-MDR and EU-IVDR Implementation
o FDA's Recent Regulation on the Use of Social Media in 2020
o Upgrade Your Medical Device Recall Strategy
o Investigating Out-of-Specification (OOS) Test Results in the Laboratory
o Sterilization of Pharmaceutical Products and Medical Devices During COVID19 New Course
o Dealing with Out of Specification Test Results in FDA Regulated Industries
o 3Hours Virtual Seminar on Successful Deviation Investigations
o Aseptic Technique and Cleanroom Behavior
o What should you know about the Clinical Trial Master File Compliance
o Meeting Global Unique Device Identification Requirements
o Pharmaceutical Quality Risk Management
o Writing Effective SOPs for the Medical Device and Pharmaceutical Industries
o Project Management for FDA-Regulated Companies
o The Use of Statistical Process Control (SPC)
o Trends in FDA Compliance and Enforcement for Regulated Computer Systems
o Current regulatory thinking on Data Integrity
o FDA’s Latest UDI Labeling Requirements Training
o Issues in Calibrations and Accuracy in Method Validation Webinar
o CAPA: Definition, Plan and Program
o Understanding the Process Validation Life Cycle Training
o EU MDR Implementation and Transitioning to the Deadline
o General Data Protection Regulation (GDPR) Compliance Training
o Good Manufacturing Practices Training | GMP Course
o Important Changes in the Latest IVDR for Software in 2020
o Pharmaceutical and Medical Device Regulations in 2020
o Good Documentation Practice (GDocP) for FDA Regulated Industries Training Online
o FDA Regulations for Analytical Instrument Qualification and Validation Processes
o Harmonized Tariff Schedule/Schedule B Classification Training
o Analytical Method Validation Under Good Laboratory Practices (GLPs) Training
o GxP/GMP and its Consequences for Documentation and IT Systems Webinar
o Full Day Virtual Workshop Qualification (IQ, OQ, PQ)
o HIPAA Audit and Enforcement Update
o Online Training On Medical Device Software 62304 Compliance
o Contract Research Organization (CRO) for success Training
o HPLC Analytical Method Development and Validation
o How to Deploy Root Cause & CAPA to Minimize Human Error
o Human Error and Cognitive Load
o Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
o Training on HIPAA Privacy Rule PrimerAnnual Product Quality Reviews; Preparation & Reports
o Artificial Intelligence (AI) in the Food Supply Chain Training
o Standard Operating Procedure e-Book (Step-by-Step Guide) Training
o Are you aware FDA’s New Import Program
o Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats Training
o Applying Computer System Validation To Mobile Applications Training
o Incoterms® 2020 Rules Training
o Understanding the Drug Supply Chain Security Act
o Electronic Records & Electronic Signatures
o Successful Supplier Audits Training
o Process Monitoring, Control and Improvement
o Regulatory Requirements for Registration of Medical Device Products in China Training
o USDA Final Genetically Modified Organism (GMO) Label Rule Training
o Investigating Out-of-Specification (OOS) Results Training
o Patient Access to Health Information, Texting, and E-mail
o HIPAA Audits and Enforcement for 2020
o FDA Compliant QC and QA Practices
o GMP Environmental Monitoring for Pharmaceutical Clean Rooms Training
o SOP Writing, Training and Compliance for the Pharmaceutical Industry Training
o Understanding and Implementing a Technology Transfer Process Training
o How to Manage Your Vendors in Clinical Research Training
o Software validation in regulated industries Training
o GCP Audits - Best Practices for Ensuring
o Validation Essentials for Medical Device Manufacturers – IQ, OQ, PQ Training
o Project Management for Non-Project Managers in the Life Sciences Training
o eCTD Submissions of IND/NDA to the US FDA, EU and Canada Training
o Human Error Tool Box: A practical aproach to human error Training
o Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment
o Construct and Manage the Technical File and Design Dossier Training
o Product Complaints: Complaint Handling From Intake To Closure Training
o Annual Product Quality Reviews
o Understanding the FDA Aseptic Processing Guidance Document Training
o Coronavirus and a new member of this family (COVID-19) Training
o Steam Sterilization Microbiology and Autoclave Performance Qualification Training
o A review of the latest prevention and treatment strategies for COVID-19 Training
o Writing and Revising SOPs for Increased Operational Efficiency Training
o An Advanced Course on Lean Documents, Lean Configuration, and Document Control
o Continuous Improvement Tools for your Quality Management System Training
o Biosafety and Blood Borne Pathogen Safety in the Lab
o Best Practices for Deviation Training
o Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries Live Webinar
o Compliant Management Controls Under 21 CFR 820 and ISO 13485
o Vaccine Patents in the Current Pandemic Climate
o Fired by Facebook - HIPAA and social media
o FDA’s Plan for Modernizing the 510(k) Pathway Webinar
o Purchasing Controls, Receiving Inspection, and Supplier Audit
o Supervising a Human Error Free Environment
o Is My Data Abnormal? Normality Tests and Transformations
o Post-Market Activities in the EU-MDR
o Non-conforming Materials in a Medical Device Company
o Are you ready for your next regulatory inspection? On site or virtual in 2021
o Learn the Latest FDA Compliance and Mobile Applications Live Webinar
o Cosmetic Ingredients: from Science to Practical Use
o From MDD to MDR: Full Training Suite Package
o Creating and Maintaining an Effective and Efficient Technical Training Program 2021
o Continuing to Audit during a Global Pandemic
o The European PSMF Live Webinar
o How FDA Trains Its Investigators to Review
o Live Webinar Sunscreens: Their Importance and US Regulations
o FDA's Endotoxin Test Guidance for Human
o FDA's current thinking on Medical Device
o From MDD to MDR: Full Training Suite Package
o Overview of Pharmacovigilance Under COVID-19 Live Webinar
o 3 hrs Webinar DHF, DMR, DHR, Technical
o Learn the latest Risk-Based Approach to CSV
o Investigating Out-of-Specification (OOS)
o A Culture of Quality is a Competitive Advantage Live Webinar
o Understanding the Design Verification and Validation Requirements for Medical Devices Webinar
o Live Webinar FDA Regulation of Artificial Intelligence/ Machine Learning
o Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA
o Managing Compliance during the Pandemic Webinar
o Batch Record Review and Product Release Training
o NEW FDA Proposed FSMA Rule on Food Traceability During COVID19 – New Course
o Properly Managing CAPA Programs for Successful Implementation
o Latest trends & Understanding Human Error
o Clinical Data Management Training
o Quality Control Laboratory Compliance
o Learn the Latest FDA’s Regulatory Management of Your Cybersecurity Threats
o Masterclass: 4 Keys to Investigating
o Cybersecurity, Data Integrity, Part 11, and Required Software Validation Training
o 7 secrets about Managing Your FDA Inspection’s 483 Observations Webinar
o 10 facts about Secrets for Writing Excellent SOPs for Medical Device QMS Live Webinar
o Data Integrity and Data Governance for Computer Systems Regulated by FDA
o Patient Access of PHI and Communications – How to Use Plain Texting and E-mail under HIPAA Training
o Best Practices To Help You Pass An FDA Computer System Validation Audit Training
o 10 Facts about Detailed Investigations
o Live Webinar How to Implement a Compliant Training Program and Reduce Human Error
o What You Need to Know IEC 62304 and Demystifying Software Validation using the Principles of LDLC
o FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data
o Understanding Quality Control Testing Webinar
o Computer System Validation (CSV) and Software Testing
o Annex 1 and its Comparison to Critical Utilities Compendial mandates
o 7 secrets about Technical Writing for the Pharmaceutical Industry Live Webinar
o Understanding the FDA: How to avoid the most recent observations
o Tips for setting up a Quality System
o FDA’s Ambitious Regulation of Social Media
o Data Integrity Practices for the Laboratory and Beyond - Webinar
o What You Need to Know: Auditing EU-MDR and EU-IVDR Implementation
o FDA's Recent Regulation on the Use of Social Media in 2020
o Upgrade Your Medical Device Recall Strategy
o Investigating Out-of-Specification (OOS) Test
o Sterilization of Pharmaceutical Products and Medical Devices During COVID19 New Course
o Dealing with Out of Specification Test Results in FDA Regulated Industries
o 3 Hours Virtual Seminar on Successful Deviation Investigations
o Aseptic Technique and Cleanroom Behavior
o Medical Device Software: Verification, Validation & Compliance Webinar
o Project Management for FDA-Regulated Companies
o The Use of Statistical Process Control (SPC)
o Trends in FDA Compliance and Enforcement for Regulated Computer Systems
o Current regulatory thinking on Data Integrity
o Issues in Calibrations and Accuracy in Method Validation Webinar
o CAPA: Definition, Plan and Program
o What should you know about the Clinical Trial Master File Compliance : A REFRESHER
o Meeting Global Unique Device Identification Requirements
o Understanding the FDA: How to avoid the most recent observations
o Pharmaceutical Quality Risk Management
o Writing Effective SOPs for the Medical Device and Pharmaceutical Industries
o EU MDR Implementation and Transitioning to the Deadline
o General Data Protection Regulation (GDPR) Compliance Training
o Good Manufacturing Practices Training | GMP Course
o Important Changes in the Latest IVDR for Software in 2020
o Pharmaceutical and Medical Device Regulations in 2020
o Good Documentation Practice (GDocP) for FDA Regulated Industries Training Online
o Pharmaceutical Training on Excipients
o FDA Regulations for Analytical Instrument Qualification and Validation Processes
o Harmonized Tariff Schedule/Schedule B Classification Training
o Analytical Method Validation Under Good Laboratory Practices (GLPs) Training
o GxP/GMP and its Consequences for Documentation and IT Systems Webinar
o Full Day Virtual Workshop Qualification (IQ, OQ, PQ)
o HIPAA Audit and Enforcement Update
o Online Training On Medical Device Software 62304 Compliance
o Contract Research Organization (CRO) for success Training
o HPLC Analytical Method Development and Validation
o How to Deploy Root Cause & CAPA to Minimize Human Error
o Human Error and Cognitive Load
o Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
o Training on HIPAA Privacy Rule Primer
o Annual Product Quality Reviews
o Artificial Intelligence (AI) in the Food Supply Chain Training
o Standard Operating Procedure e-Book (Step-by-Step Guide) Training
o Are you aware FDA’s New Import Program
o Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats Training
o Applying Computer System Validation To Mobile Applications Training
o Save Your Food Business!! - Business Continuity & Disaster Recovery Training
o Incoterms® 2020 Rules Training
o Understanding the Drug Supply Chain Security Act
o Qualification (IQ, OQ, PQ) and Validation
o Construct and Manage the Technical File and Design Dossier Training
o Product Complaints: Complaint Handling From Intake To Closure Training
o Annual Product Quality Reviews; Preparation & Reports
o Understanding the FDA Aseptic Processing Guidance Document Training
o Understanding the FDA Aseptic Processing Guidance Document Training
o An Advanced Course on Lean Documents, Lean Configuration, and Document Control
o A Comprehensive View of Medical Device Post
o 3 Days Virtual Seminar on Advanced Pharmacovigilance Auditing and Inspections
o 3 Days Virtual Seminar on Advanced Pharmacovigilance Auditing and Inspections
o Computer System Validation Professional Certification Program 3 Days
o Computer System Validation Professional Certification Program 3 Days
o FDA Computer System Validation ( CSV)
o 2-Day Instructor-led Virtual Seminar FDA Inspection Essentials in 2021
o 2-Day Instructor-led Virtual Seminar FDA Inspection Essentials in 2021
o Human Error Certification Training Program Training
o Biostatistics for the Non-Statistician
o Lifecycle Management of Analytical Methods and Procedures
o The Veterinary Drug Approval Process and FDA Regulatory Oversight Training
o The Veterinary Drug Approval Process and FDA Regulatory Oversight Training
o Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course
o The Drug Development Process from Concept to Market
o 3 Day Web Seminar Understanding Medical Device Design Controls What, Why, and How
o Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products
o What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections Live Webinar
o FDA’s Regulation of OTC Drug Products
o Basic GMP Training for the QC Laboratory
o FDA Recalls - Before You Start, and After You Finish 2 Day Seminar
o FDA Recalls - Before You Start, and After You Finish 2 Day Seminar
o Statistics for Process Control
o 6 hr Virtual Seminar Statistics for Process Control
o Aseptic Process Validation : Critical for compliance and success Virtual Training
o A Comprehensive View of Medical Device Post
o Process Validation Guidance Requirements (FDA and EU Annex 15
o Post-Market Activities in the EU-MDR
o From MDD to MDR: Full Training Suite Package
o Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment
o Investigating Out-of-Specification (OOS)
o 21 CFR Part 11 (Electronic Records/Electronic Signatures)
o Batch Record Review and Product Release Training
o Clinical Data Management Training
o Quality Control Laboratory Compliance
o What You Need to Know IEC 62304 and Demystifying Software Validation using the Principles of LDLC
o Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
o Current regulatory thinking on Data Integrity
o Understanding the Process Validation Life Cycle Training
o Understanding the FDA: How to avoid the most recent observations
o EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete in 2020
o SOP Writing, Training and Compliance for the Pharmaceutical Industry Training
o Project Management for Non-Project Managers in the Life Sciences Training
o eCTD Submissions of IND/NDA to the US FDA, EU and Canada Training
o Human Error Tool Box: A practical aproach to human error Training
o Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems
o 7 secrets about Technical Writing for the Pharmaceutical Industry Live Webinar
o Overview of Pharmacovigilance Under COVID-19 Live Webinar
o Pharmaceutical Compressed Air
o The Microbiology of Water in a GMP Environment
o The Veterinary Drug Approval Process and FDA Regulatory Oversight Training
o Quality Control Laboratory Compliance - cGMPs and GLPs Training
o Pharmaceutical Quality Risk Management
o Good Manufacturing Practices Training | GMP Course
o Good Documentation Practice (GDocP) for FDA Regulated Industries Training Online
· Login
· Sign Up
· About Us