Customized On-site Life Sciences Training Customized On-site Life Sciences Training

Customized-On-site-Life-Sciences-Training-Programs

Popular Course Titles

The Life Science Training Institute (LSTI) has two guiding principles that drive every customized learning experience we create:

1. The Best Instructors

LSTI employs the best minds in industry to develop and deliver our programs — Subject Matter Experts (SMEs) who can handle almost any topic from discovery to commercialization. We cover training in R&D, pre-clinical, clinical, regulatory, manufacturing, compliance, quality, risk-management, and more.

2. Superior Course Design

LSTI is focused on delivering training that sticks. Our SMEs build robust courses that engage learners with exercises, intermediate knowledge checks, assessments, and other powerful educational tools for the adult learner. Checklists, templates, and other learning reinforcement tools keep your staff engaged with the content long after the course.

We offer a broad range of courses categorized into the following topics: (View some of our popular course titles by clicking the topic below.)

Clinical Trials Training

Manufacturing Training

Medical Device Training

Pharmaceutical Training

Regulatory & Compliance Training

Research & Development Training

 

Clinical Trials Training

  • A Risk-based Study Management Approach for Clinical Sites
  • Applying Biostatistics to Clinical Trial Design
  • Building Accountability on Your Clinical Teams
  • Clinical Finance Key Strategies to Stay in Control of Your Study Budget
  • Clinical Study Requirements Understanding Differences Between the US and EU
  • Conducting the CRO Pre-qualification Audit for GCP Compliance Key Risk Factors to Avoid
  • CRA Oversight - A Risk-based Approach
  • Critical Site Readiness Steps for the Pre Study Assessment Visit How to Turn Study Consideration to Study Award
  • CRO Oversight Risk Assessment Action Planning
  • CRO Selection and Oversight A Risk-Based Approach
  • Electronic Investigator Site File Digital Storing of Documents for Inspection Readiness
  • FDAs Mandate Requiring Conformance to SEND and SDTM for Pharma Submissions What is the Vision
  • FINAL Risk-based Monitoring Guidance Updates Impact Analysis on Clinical Monitoring Systems
  • Finally…Update to ICH GCP E6 (R2) Critical Updates You Must Know!
  • Five Critical Steps To a Executing a Successful Medical Device Clinical Strategy - Compliant Trial Design That Works
  • Good Documentation Practices for Clinical Trials Ensuring Air-Tight Results
  • HIPAA Source Data Access Dispelling the Myths
  • Identifying and Closing the Training Gap in Clinical Research
  • Introduction to Biostatistics Collecting and Summarizing Data
  • Introduction to Biostatistics Hypothesis Testing
  • Investigator Meeting Training No GCP 101 Please!
  • It’s Ten O’Clock Do You Know Where Your Trial Master File Is
  • Medical Device GCPISO 14155 Standard Investigator Training
  • Modernization of Investigator Oversight Matching Current Requirements with Future Needs
  • Monitoring Electronic Health Records (EHRs) Frequently Asked Questions
  • Monitoring Informed Consent (IC) Frequently Asked Questions
  • Monitoring Medical Device Trials Using the ISO 141552011GCP Standard
  • Partnership Strategies with CROVendors Create Relationships that Create Results
  • Pediatric Clinical Trials Special Considerations and Requirements
  • Performing Risk Assessment Within GCP
  • Quality by Design (QbD) in Clinical Trials - Build Bullet-Proof Protocols
  • Quality Risk Management for GCP Professionals Keys for Successful Application
  • Remote Monitoring of Clinical Source Data Why Not
  • Risk-based Monitoring Plan Development
  • Root Cause Analysis for Clinical Research Professionals
  • Root Cause Analysis for GCP A Risk Action Plan Guide
  • Source Data Review (SDR) vs Source Data Verification (SDV) A Site Monitoring Best Practices Update
  • Standard Operating Procedure Training - How to Write SOPs That are GCP Compliant
  • Strategic Clinical Project Management Principles and Practical Applications
  • Surviving a FDA GCP Inspection Preparation Techniques for Success
  • Writing Clinical Monitoring Reports Using the Liquid Report Writing Method

Back to top.

Manufacturing Training

  • Aging Aseptic and Biological Manufacturing Facilities - Renovation for Survival
  • Best Practices for Deviation Investigations Cost-effective Problem Correction
  • Building An Effective GMP Training System A Risk-Based Approach
  • cGMP Compliance - Top Drug Enforcement Trends For 2015
  • cGMP Compliance - Top Trends to Know for 2014
  • Cleaning Validation -- Lessons Learned in the Trenches
  • Competency-Based Training in a GMP Environment Results Based on Roles and Responsibilities
  • Data Integrity Manufacturing - Detecting Mitigating Risk
  • Effective Investigations Root Cause Analysis A Step-by-Step Guide for Manufacturers
  • Effective Validation Master Planning Key Steps for Success
  • Good Manufacturing Practices (GMP) An Introduction
  • Improving Biological Facility Design 10 Critical Tips for Compliance
  • Instructional Design for GMP Training Improve Effectiveness and Measurability
  • Making Training Stick Ensuring Your GMP Task Training Is Effective
  • Process Validation Guide Regulatory Expectations and Best Practices
  • Qualifying Your Life Science Trainers What Do They Need for Your Training to Be Effective
  • Quality by Design (QbD) Building Knowledge and Skills Required for Successful Implementation
  • Reacting to “Human Error” Moving Beyond “Retraining” As A Response
  • Reducing Human Error in Life Sciences Manufacturing
  • Renovating Pharmaceutical Manufacturing Facilities to Accommodate Aseptic Fill Finish Critical Planning Execution Compliance Tips
  • Single-Use Disposable Process Technologies - Best Practices
  • The Nuts and Bolts of a Quality Manual Avoiding Pitfalls and Ensuring Compliance
  • The Top Method Validation Mistakes And How to Avoid Them
  • Understanding Aseptic Technique and Cleanroom Behavior Avoiding Human Error
  • Understanding Cleanroom Microbiology Building A Foundation For Compliance

Back to top.

Medical Device Training

  • Analyzing and Understanding ISO 13485 Proposed Changes
  • Attribute Acceptance Sampling (Z14) for Medical Device Manufacturers
  • CE Marking of Medical Devices A Step-by-Step Guide for Compliance
  • Competitive Medical Device Regulatory Strategy Creating Market Barriers for your Competition
  • Design Controls 101 A Practical Crash Course
  • Device Quality Audits Your Best Defense Against A FDA 483
  • Effective Complaint Handling and Management Medical Devices
  • Effective Risk Management & Quality System Implementation for Medical Devices
  • How to Prepare for an FDA Inspection of Medical Devices
  • Medical Device Compliant Handling and MDR Reporting
  • Preparing for - and Surviving - a FDA Medical Device Inspection
  • Risk Management for Medical Devices Converting to EN ISO 149712012
  • The New Medical Device Single Audit Program (MDSAP) for Manufacturers Analyzing Rewards and Challenges
  • Unique Device Identification (UDI) Best Practices

Back to top.

Pharmaceutical Training

  • Authoring and Implementing Standard Operating Procedures (SOPs) Best Practices for Success
  • Bad Standard Operating Procedures (SOPs) Bad Training Garbage In Garbage Out
  • Coping With Change A Primer for Staff and Managers
  • Drug Development 101 How A Drug Is Made
  • Make Your Supplier Management Program Inspection Ready!
  • The Seven Characteristics Of A World Class Supply Chain
  • Vendor Qualification and Compliance What Sponsors CMOs Must Know

Back to top.

Regulatory & Compliance Training

  • 21 CFR Part 11 Understanding the ERES Regulation for Compliance Success
  • Accelerated Regulatory Review Tips to Speed Your Products to Market
  • Adverse Event Reporting Avoiding Common Pitfalls
  • Best Practices in CMC Dossier Preparation Facing Tough Challenges
  • Cloud Computing In A GxP Environment Three Key Success Factors
  • Communication With FDA What Do We Say And How Do We Say It
  • Compliance Validation Requirements for Serialization - Keys to Success
  • Computer Systems Validation (CSV) Avoiding The Top Five Regulatory Pitfalls - Training Course
  • Cost-EfficientCost-Effective Validation Protocols
  • De Novo Path to Device Approvals Tips for Speedy Successful Outcomes
  • Device Compliance Audit Management - Best Practices to Meet Global Regulations and Notified Body Expectations
  • FDA Guidance on Social Media Questions Answered and Unanswered
  • FDA Pre-Sub Meetings for Medical Devices Make The Most Of Your Opportunity
  • FDA Quality Metrics Draft Guidance What You Need to Know to be Prepared for Implementation
  • Got a Date with the FDA Conducting Successful Meetings
  • How To Take Advantage Of The Companion Diagnostics Opportunity
  • Impact of Serialization on Pharmaceutical Business Processes and Procedures
  • Launching a PharmacueticalBiopharmaceutical Product in 2015 Avoiding Pitfalls Maximizing Impact
  • Medical Device Regulatory Affairs 101 Regulatory Affairs For Non-Regulators
  • Medical Device Regulatory Compliance Changes Managing Unannounced Visits from Notified Bodies
  • New FDA Draft Guidance eCTD Is Coming to Promotional Submissions…Are You Ready
  • New Pharma Compliant Google Ad Formats Implementation Tips For Success
  • Pharmaceutical Serialization Regulatory Requirements for the Americas
  • Preparing Investigators for FDA Inspections Frequently Asked Questions
  • Preparing Personnel to Interact with Regulatory Inspectors
  • Process Validation Training - Ensuring Compliance With Multiple Standards
  • Project Management Best Practices for Validation Regulatory Projects
  • Protocol Deviations Calculated Risk or Risk to be Managed
  • Quality Agreements FDA What You Must Know to Comply
  • Quality Assurance and Quality Control - Differences in FDA vs EU Regulations
  • Reprocessing Medical Devices Final Guidance How To Meet New Validation Requirements
  • Risk Management for Medical Devices A Compliance Primer
  • Serialization and Product Traceability - Global Regulatory Requirements
  • Serialization Preparedness What you Must Know for Bullet-Proof Programs
  • Serialization Regulatory Requirements for Asia and Emerging Markets
  • Serialization Regulatory Requirements for EMEA (Europe Middle East and Africa)
  • Successful FDA Interactions Practical Approaches to Ensure Positive Outcomes
  • The Future Of Biosimilars Addressing Regulatory Challenges
  • The Investigational
  • The Premarket Approval Pathway Ensure Successful Regulatory Submissions
  • The Premarket Notification510k Submission Using Substantial Equivalence to your Advantage!
  • Top IND Pitfalls How to Avoid Them
  • Understanding the Medical Device Classification System Best Practices for Selecting the Best Fit
  • Using Social Media for Patient Recruitment in Clinical Trials

Back to top.

Research & Development Training

  • An Introduction to Good Laboratory Practices (GLP)
  • Lyophilization - An Introduction to the Scientific Principles
  • Lyophilization - Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyo Cycles
  • Lyophilization Cycle Design A Practical Guide to Process Optimization
  • Stability Programs - Key Factors in Meeting FDAICH Regulations
  • Surviving A FDA Good Laboratory Practices (GLP) Inspection Critical Tips For Compliance

Back to top.

Use Wufoo integrations and get your data to your favorite apps.