Online Compliance Training, FDA compliance training, Risk Management for medical device

Life Sciences

Upcoming Webinar
On-Demand webinar

Manage Your FDA Inspection Before It Happens

By Casper E Uldriks | Date: Wednesday, 20 February 2019 | Duration: 60 Minutes

Controlling Human Error on the Manufacturing Floor

By Dr. Ginette M. Collazo | Date: Tuesday, 26 February 2019 | Duration: 90 Minutes

Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles of Lean Documents and Lean Configuration

By Jose Ignacio Mora | Date: Tuesday, 26 February 2019 | Duration: 90 Minutes

The Problem of Bacterial Spores and Sporicidal Disinfection

By Tim Sandle | Date: Thursday, 21 February 2019 | Duration: 60 Minutes

Practical Strategies for Compliance with USP 800: Hazardous Drug Compliance and Safety in 2019

By Igor Gorsky | Date: Wednesday, 27 February 2019 | Duration: 90 Minutes

Production and Process Controls - Ensuring Your Medical Device Conforms to its Specifications

By Denise Wrestler | Date: Wednesday, 27 February 2019 | Duration: 60 Minutes

Equipment Validation, Tracking, Calibration and Preventive Maintenance

By Jeff Kasoff | Date: Thursday, 21 February 2019 | Duration: 60 Minutes

Classifying Medical Devices, The De Novo Process and the FDA's Final Rule to Simplify Medical Device Classification Procedures

By Charles H Paul | Date: Thursday, 21 February 2019 | Duration: 60 Minutes

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IQ, OQ, PQ in the Verification and Validation Process

By Kenneth Zabel

FDA Good Laboratory Practice (GLP) Inspection Preparation and Management: Dos and Don’ts

By David Lim

Draft Guidance for Device Industry and FDA - Postmarket Surveillance

By David R Dills

Improving 510(k) Submission Quality

By David Lim

ISO 13485 Quality Management System

By Peter Spath

The Basic Requirements for Developing IQ and OQ Protocols

By Kenneth Christie

Medical Device Laws and Regulations in China, Hong Kong, Japan and Korea

By David Lim

The FDA Inspection Process: From SOP to 483

By Jeff Kasoff

Establish and Maintain an Effective Supplier Qualification Program

By David R Dills

Effective Pharmaceutical GMP Audits and Self-Inspections

By Carl Patterson

Medical Device Compliance with MEDDEV 2.7.1 Rev 4 for Clinical Evaluation / CER Reporting

By Salma Michor

Lyophilization and Stabilization of Proteins, Cells and Viruses

By Jeff Schwegman

FDA Regulatory Control of the Drug Development Process and Investigator Responsibility in the Process

By Dr Charles H Pierce

Auditing for 21 CFR Part 11

By Herman Wong

Creating a Good Design History File (DHF) for Audit Success

By Mercedes Massana

Implementing a Stability Program for a Biologic

By Gwendolyn Wise-Blackman

Equipment Qualification and Process Validation

By Loren Gelber

Approaches to Improve Regulatory Information Policies and Procedures

By Charlie Sodano

QSR-Compliant Equipment Control & Validation of Processes in the Manufacturing Environment

By Joy McElroy

Preparing for FDA Inspection and Management including GLP Inspection: Best Practices

By David Lim

Improved Generic Drugs via the 505(b)(2) Regulatory Pathway: FDA Approval Made Easy

By Mukesh Kumar

Use GAMP to Surefire your CSV Audit

By Chinmoy Roy

Stunning Changes in FDA's Software Regulation

By Casper E Uldriks

Quality system requirements for cleaning, maintenance and calibration programs

By Kenneth Christie

How to Prepare for and Host a FDA Inspection and Avoid 483's

By Edwin Waldbusser

Why is Liver Injury (DILI) the Most Frequent Reason for a Drug Being Pulled from the Market

By Dr Charles H Pierce

EU GMP Annex 1 - What's New for Sterile Product Manufacturing?

By Tim Sandle

The Hitchhiker's Guide to 483s and Warning Letters

By Angela Bazigos

FDA Approval of Adaptive Clinical Trials: Practical Tips to Maximize Benefits from Smart Trial Design

By Mukesh Kumar

HIPAA Designed for the Front Office Staff

By Rhonda Granja, B.S., CMC, CMOM, CMA, CPC

Investigator initiated trials- What are we doing to ensure human subject protection?

By Dr. Nagina Parmar

510(k) Submission: Contents and Format for Medical Devices

By David Lim

Implementing the ASTM E2500 Validation Method

By Kelly Thomas

FDA Warning Letter Management

By Casper E Uldriks

Applying Global Standards to Life Sciences Compliance Documentation

By Charles H Paul

Submitting FDA Electronic Regulatory Filings – Drug Establishment Registrations and Drug Listings

By Camille Davis Thornton

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

By Steven Wachs

Trial Master File (TMF): FDA Expectations from Sponsors and Sites

By Mukesh Kumar

Establishing a Robust Supplier Management Program

By Kelly Thomas

Construct and Manage the Technical File and Design Dossier

By David R Dills

How to select Software for a Regulated Environment

By Angela Bazigos

Comparing the Pharmaceutical and Medical Device Lifecycles

By Howard T Cooper

Quality SOPs: Guidelines to developing and writing FDA Compliant Documents

By Chitra Edwin

EU Medical Device Directive: Preparing for Conformity Assessment Application for CE Marking of Medical Devices

By David Lim

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer

By Gregory Martin

Best Practices for Purchasing and Supplier Controls in the Medical Device Industry

By Jeff Kasoff

Step-by-Step Process for Successful Sterility Failure Investigations

By Danielle DeLucy

ISO 14644 - The Revised Standard and Implications for Cleanrooms

By Tim Sandle

Optimized Formulation Development for Lyophilized Products

By Jeff Schwegman

21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

By Jose Ignacio Mora

Cybersecurity Exploitation Recovery

By Casper E Uldriks

Risk Management for Medical Devices: ISO 14971:2007

By Ron Schoengold

Good Design Practices For Pharmaceutical Water Systems

By Tim Sandle

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer

By Gregory Martin

Recent cGMP Violations and How to Avoid Citations

By Dr. James R Harris

Computer System and Software Validation

By Peter Spath

Is it Method Verification or Validation, or Just Semantics?

By Michael Brodsky

FDA's New Guideline regarding Contract Manufacturing Arrangements for Drugs: QUALITY AGREEMENTS

By Dr. James R Harris

Risk Assessment in Cleaning Validation

By Igor Gorsky

Fungal Contamination and Pharmaceutical Products Recall

By Tim Sandle

A Regulatory Perspective: FDA's New Guidance's Deciding When to Submit a 510(k) for Device & Software Changes

By Carolyn Troiano

Good Practices for an FDA Inspection Preparation and Readiness: Dos and Don'ts

By David Lim

FDA Inspection and Medical Device Design Control

By David Lim

Good Documentation Guideline (Chapter 1029 USP)

By Dr. Afsaneh Motamed Khorasani

Medical Device Employee Training - Requirements and Implementation Tips

By Betty Lane

Burkholderia cepacia - Risks in Context for Non-Sterile Pharmaceutical Products

By Tim Sandle

The Sunshine Act Reporting for Clinical Trials

By Mukesh Kumar

Effective Root Cause Analysis: The Key to an Effective Corrective Actions System

By Betty Lane

Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success

By Michael Esposito

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

By Gregory Martin

Hazard Analysis Following ISO 14971

By Edwin Waldbusser

What to identify? Why Screening Cleanroom Microbes Matters

By Tim Sandle

Import of FDA Regulated Products into the US: FDA and Customs Requirements at the Port of Entry

By Dr. Rossano V. Gerald

510(k): Regulatory and Technical Requirements Compliant with eCopy and RTA Policy

By David Lim

How to Write Procedures to Avoid Human Errors

By Dr. Ginette M. Collazo

Overview of the Mexican Labeling Standards and the New Labeling Requirements

By Esther Diaz

How To Conduct a Successful Process Validation

By Dr. James R Harris

New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines

By Gregory Martin

cGMP for Medical Devices Including In Vitro Diagnostic Medical Devices

By David Lim

GMP Vendor Audits

By Dr. James R Harris

FDA BIMO Inspection: Preparation and Management: Dos and Don'ts

By David Lim

Writing and Enforcing Effective SOPs

By David R Dills

Acceptance Activities in FDA's Quality Management System

By Daniel O'Leary

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

By Dr. Ginette M. Collazo

Control of Cleanroom Garments and Supplies: Contamination Control

By Tim Sandle

IQ, OQ, PQ in the Verification and Validation Process

By Susanne Manz

How to withstand an FDA audit of your facility

By Mukesh Kumar

Good Documentation Guideline (Chapter 1029 USP)

By Dr. Afsaneh Motamed Khorasani

The DIOM - A Straightforward Method for Meeting FDA Requirements for Design Inputs and Outputs

By Denise Wrestler

Compliant Management Controls Under 21 CFR 820 and ISO 13485

By Jeff Kasoff

Update: Medical Device Laws and Regulations in China, Hong Kong, Japan and Korea

By David Lim

Understanding Freezing, Annealing, Primary and Secondary Drying in the Freeze-Drying Process

By Jeff Schwegman

General Data Protection Regulation (GDPR): Compliance for Clinical Trials

By Laura Brown

Role of Logbooks and Recordkeeping in Identifying Root Causes in Labs

By John Fetzer

FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies

By Kenneth Christie

FDA's Off-label Promotion in Social Media

By Casper E Uldriks

FDA Inspection: Preparation and Management

By David Lim

Are Electronic Cigarettes a Public Health Threat or Benefit?

By Azim Chowdhury

Designing And Implementing The Quality System From Scratch

By Howard T Cooper

IND Submission for a 505(b)(2) Product

By Mukesh Kumar

21 CFR 11 Compliance for Excel Spreadsheets

By Angela Bazigos

Laboratory Safety: Efficient Environmental, Health and Safety (EHS) Management

By Dr. Vince Marchesani

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration

By Jose Ignacio Mora

CMC Requirements for Cell and Gene Therapy

By Gwendolyn Wise-Blackman

GMP Quality Principles

By Dr. James R Harris

Testing Medical Devices for Efficiency and Efficacy

By Dev Raheja

Determining a Regulatory Pathway for your Over-the-Counter (OTC) Drug Product

By Camille Davis Thornton

Successful 510(k) Documentation for Software or Software Containing Medical Devices

By Nancy J. Knettell

Software Process Verification and Validation

By Dev Raheja

Through the Eyes of an Auditor

By Jose Ignacio Mora

Part 11 Compliance and the Role of Standard Operating Procedures

By Herman Wong

Off-Label Uses of Medical Products Under FDA Rules: Walking the Fine Line of Promotion Verses Scientific Discussion

By Mukesh Kumar

FDA's Medical Device De Novo Reclassification Process

By Charles H Paul

21 CFR Part 11 Complying with: Step by Step

By Chinmoy Roy

Establishing a Medical Device Reporting System Integrated with a UDI System

By David Lim

Computer System Validation

By Edwin Waldbusser

Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

By Harry Huss

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

By Carolyn Troiano

FDA - Streamlining Your Internal Auditing Process

By Betty Lane

Do's and Don'ts during FDA Inspections

By Jeff Kasoff

GMP's for Medical Marijuana - Insight into Manufacturing, Labeling, Tracking and Disposal requirements

By Charles H Paul

Key Factors to Write an Effective Standard Operating Procedures (SOP) and Work Instructions (WI)

By Joy McElroy

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?

By Dr Charles H Pierce

Software Validation & Testing - Regulatory Requirements

By Dev Raheja

FDA Premarket Application Pathways for E-Cigarettes and Other New Tobacco Products

By Azim Chowdhury

CAPA Simplified - A One-Form, Easy-To-Complete, Method for Simplifying Your CAPA Process

By Denise Wrestler

Current Concepts & Challenges in Cloud Compliance

By Angela Bazigos

FDA Rules for using Social Media for Marketing Prescription Products

By Mukesh Kumar

Practical Guide to FDA Inspections

By Casper E Uldriks

Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter

By Jeff Kasoff

Understanding the Brazilian Regulatory Environment for Medical Devices

By Claudia De Lucca Mano

Understanding the FDA's Revised Medical Device Product Guidance - Refuse to Accept Policy for 510(k)s and Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

By Charles H Paul

Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles

By Jeff Schwegman

In Depth Testing of Computer Systems Regulated by FDA

By Carolyn Troiano

FDA 510(k): Trends, Hurdles, Submission and Clearance

By David Lim

Overview of FDA Regulations for Drugs, Biologics and Medical Devices including IVDs

By David Lim

GMP Audits: Tools and Techniques

By Carl Patterson

Implementing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

By Kelly Thomas

Human Microbiome and Implications for Contamination Control

By Tim Sandle

Safe Drinking Water-Another Oxymoron?

By Michael Brodsky

Changes in FDA's Device Corrections and Removals Reporting

By Casper E Uldriks

Best Practices for MDRs, Recalls, Corrections, and Removals

By David Lim

How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

By Loren Gelber

Onboarding Employees In A GMP Environment: Best Practices For Foundational Employee Success

By Michael Esposito

Writing US FDA-acceptable Clinical Trial Protocols

By Mukesh Kumar

Stability Studies and Estimating Shelf Life

By Steven Wachs

FDA Rules for Trial Master Files

By Mukesh Kumar

The New EU Medical Device Regulation

By Salma Michor

Cleaning Validations Using Extraction Techniques

By Kierstan Andrascik

Preparing for an FDA Audit of your facility

By Mukesh Kumar

IRB and Other Committees

By Richard L. Chamberlain

FDA's Off-label Promotion in Social Media

By Casper E Uldriks

Technical Writing in an Industrial Environment

By Robert Peoples

Implementing Design control for Medical Devices and IVDs

By David Lim

Advertising and Promotional Material Compliance and Review Process

By Peggy J. Berry

Implementing Medical Device Reporting

By David Lim

Scale Up and Cycle Transfer for Lyophilization Cycles

By Jeff Schwegman

Generation of Controlled Documents and Related Training

By Jerry Dalfors

The Problem of Bacterial Spores and Sporicidal Disinfection

By Tim Sandle

Lyophilization Process Development and Cycle Design

By Jeff Schwegman

Project Management for Computer Systems Validation

By Angela Bazigos

Preparing for FDA BIMO Inspection and Management

By David Lim

Implementing an Internal Audit Program Pursuant to ISO 13485 and 21 CFR Part 820

By David Lim

Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

By Gregory Martin

Efficient and Effective Batch Record Reviews to Improve your Process Capabilities

By Danielle DeLucy

Medical Device Single Audit Program (MDSAP) - All You Need To Know

By Walter E. Murray

Writing Effective SOP’s for Quality Professionals: Best Practices for Life Science Companies

By Joy McElroy

Adverse Event Reporting Compliance; The Key to Safe Drug Development / Subject Safety

By Dr Charles H Pierce

3-hr Virtual Seminar: Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)

By Howard T Cooper

FDA Import and Export Requirements

By Casper E Uldriks

Best Practices for Implementing an Effective Cleaning Validation using Principles of Upcoming ASTM E3106

By Igor Gorsky

Writing Effective SOP’s

By Angela Bazigos

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements

By Betty Lane

Bonified CAPA Investigations

By Walter E. Murray

FDA Investigations and Inspections

By Luis Chavarria

Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration

By Jose Ignacio Mora

Post Approval Risk Management Strategy

By Peter Spath

How to Translate Academic and Discovery Assays into GLP Compliant Assays

By Todd Graham

Process Validation – Principles and Protocols

By Jeff Kasoff

Microbiological and Business Risk of Not Testing Raw Materials for Microbial Presence

By Carl Patterson

21 CFR Part 11 - Electronic Record and Signature Validation

By Edwin Waldbusser

Establishing a Compliant and Effective Change Control Program

By Kelly Thomas

Records Preservation Strategies that will Assure Authentication

By Charlie Sodano

Sampling - How Large a Sample Do I Need? Determining the Right Size for Accurate, Cost Effective Results

By Ronald D. Snee

Dietary Supplements and Nutraceuticals: Compliance with FDA's Current Manufacturing Requirements

By Mukesh Kumar

Record Retention - Long Enough or Too Long? A practical Guide

By Charlie Sodano

How to Implement a Risk Management Process

By Chris Doxey

Managing Documents, Records, and Data for FDA Inspections

By Susanne Manz

Problem Solving - Root Cause Analysis in Pharma Manufacturing

By Joy McElroy

10 Steps to an FDA-Acceptable Clinical Trial Protocol

By Mukesh Kumar

Developing an Effective Risk Management Plan for Medical Devices

By Daniel O'Leary

Internal GMP Audits

By Dr. James R Harris

CAPA Training and Causes of Warning Letters due to Lack of Comprehension

By Jerry Dalfors

Stability Studies and Estimating Shelf Life with Regression Models

By Steven Wachs

ICH-FDA Good Clinical Practice – Managing Clinical Trials

By Marie Dorat

USDA GMO Labeling - What to Expect from the 2018 Final Rule

By Norma Skolnik

Bulletproofing your cGXP Documentation from Audit Citations

By Chinmoy Roy

Best Practices Compliant with the FDA Regulations for Handling Medical Device Complaints

By David Lim

Risk Based Clinical Trial Monitoring

By Laura Brown

FDA 510(k) Update: Recent Trends and Good Practices Compliant with eCopy and RTA policy

By David Lim

10 Steps to Perfect SOPs: FDA Acceptable SOPs made Easy

By Mukesh Kumar

Quality Management Systems for Medical Devices and IVDs

By David Lim

Technical Writing Best Practices

By Robert Peoples

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

By Edwin Waldbusser

Data Governance for Computer Systems Regulated by FDA

By Carolyn Troiano

Effective and Practical use of FMEA For Risk-Based Approach to Computer Systems Validation

By Joy McElroy

FDA vs EU Inspections – Getting Prepared and What are Differences

By Marie Dorat

Critical SOPs for Clinical Sites

By Mukesh Kumar

Managing Foreign Inspections - Before, During and After

By Casper E Uldriks

10 Steps to Perfect SOPs: FDA Compliance made easy

By Mukesh Kumar

The Infamous Form FDA 483: How you respond can make or break you

By Casper E Uldriks

Container – Closure Systems for Lyophilized Products

By Jeff Schwegman

Requirements for Medical Device Developers to Meet the U.S. FDA's Requirements on the 510(k)

By David Lim

FDA - Streamlining Your Internal Auditing Process

By Betty Lane

In Depth Testing of Computer Systems Regulated by FDA

By Carolyn Troiano

Putting together a Q-Submission and 510(k): Best Practices

By David Lim

How to Develop Quality Systems for New Diagnostic Assays

By Todd Graham

New Rules for Compounding Pharmacies: Best Practices for Compliance

By Mukesh Kumar

Practical Strategies to a successful 505(b)(2) product

By Mukesh Kumar

Computerized System Validation: Basic Concepts

By Angela Bazigos

FDA Part 820 Basics - Everything you Need to Know to Get your Start-up Company Compliant

By Denise Wrestler

510(k): Submission and Clearance

By David Lim

510(k): Format, Contents and Case Studies

By David Lim

Qualification of Contract Manufacturer Organizations Based on Practical Experience

By Edwin Waldbusser

FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS

By Joy McElroy

How FDA Inspection Observations are Reviewed for Regulatory Action

By Luis Chavarria

FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List

By David R Dills

Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements

By Mukesh Kumar

Technical Writer Training

By Robert Peoples

Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical Manufacturing

By Carl Patterson

Discussion Regarding the Substitution of a New Inactive Ingredient in an Approved Parenteral Drug Product

By Lamont M. Fulton

510(k): How To Navigate Through Hurdles And Get It Cleared

By David Lim

Systems Validation Made Easy

By Herman Wong

EU GDPR Deadline is Just around the Corner: Understanding Compliance for Clinical Trials for Life Sciences Companies

By Laura Brown

Managing the FDA form "483": Inspection Observations

By Casper E Uldriks

IEC 62304: Medical Device Software Development and Validation

By Chinmoy Roy

Strategies to Capture, Preserve and Authenticate R&D Information for Patent Protection and Litigation

By Charlie Sodano

Global Best Practices for Cleaning and Disinfection of Cleanrooms and Disinfection Validation

By Tim Sandle

System Suitability Testing in the Pharmaceutical Laboratory: Addressing FDA and USP Compliance

By Gregory Martin

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