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

Life Sciences

Upcoming Webinar
On-Demand webinar

Systems Engineering: A Critical Need for Safety and Reliability in Healthcare

By Dev Raheja | Date: Thursday, 24 October 2019 | Duration: 60 Minutes

Analytical Instrument Qualification - Practical Approaches for Revised USP General Chapter 1058 Compliance

By Gregory Martin | Date: Wednesday, 16 October 2019 | Duration: 90 Minutes

Cannabinoids as Drugs - Latest Updates

By Loren Gelber | Date: Tuesday, 29 October 2019 | Duration: 90 Minutes

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

By Carolyn Troiano | Date: Wednesday, 16 October 2019 | Duration: 90 Minutes

Writing Effective Standard Operating Procedures and Work Instructions

By Charles H Paul | Date: Thursday, 24 October 2019 | Duration: 60 Minutes

FDA's Medical Device De Novo Reclassification Process

By Charles H Paul | Date: Friday, 25 October 2019 | Duration: 60 Minutes

Aging Pharmaceutical Facilities - A Deep Dive into the Risk Factors

By Tim Sandle | Date: Thursday, 17 October 2019 | Duration: 60 Minutes

Best Practices for Implementing an Effective Cleaning Validation (Using Principles of Upcoming ASTM E3106)

By Igor Gorsky | Date: Thursday, 17 October 2019 | Duration: 90 Minutes

Effective Records Management & Document Control for Medical Devices

By Susanne Manz | Date: Tuesday, 22 October 2019 | Duration: 90 Minutes

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The Basic Requirements for Developing IQ and OQ Protocols

By Kenneth Christie

Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

By Loren Gelber

USP 1224 Transferring the Method to meet Regulatory Expectations

By Carl Patterson

Auditing for 21 CFR Part 11

By Herman Wong

Do's and Don'ts during FDA Inspections

By Jeff Kasoff

Records Preservation Strategies that will Assure Authentication

By Charlie Sodano

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

By Dr Charles H Pierce

Writing and Enforcing Effective SOPs

By David R Dills

Best Practices for MDRs, Recalls, Corrections, and Removals

By David Lim

Stability Studies and Estimating Shelf Life

By Steven Wachs

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

By Jose Ignacio Mora

Optimized Formulation Development for Lyophilized Products

By Jeff Schwegman

What to identify? Why Screening Cleanroom Microbes Matters

By Tim Sandle

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

By David Lim

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

By Gregory Martin

Writing US FDA-acceptable Clinical Trial Protocols

By Mukesh Kumar

Post Approval Risk Management Strategy

By Peter Spath

How to Translate Academic and Discovery Assays into GLP Compliant Assays

By Todd Graham

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

By David Lim

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

By Gregory Martin

Safe Drinking Water-Another Oxymoron?

By Michael Brodsky

How to Write Procedures to Avoid Human Errors

By Dr. Ginette M. Collazo

Computerized System Validation: Basic Concepts

By Angela Bazigos

Computer System and Software Validation

By Peter Spath

Manage Your FDA Inspection Before It Happens

By Casper E Uldriks

The Hitchhiker's Guide to 483s and Warning Letters

By Angela Bazigos

Preparing for an FDA Audit of your facility

By Mukesh Kumar

New Rules for Compounding Pharmacies: Best Practices for Compliance

By Mukesh Kumar

How To Conduct a Successful Process Validation

By Dr. James R Harris

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

By David Lim

Through the Eyes of an Auditor

By Jose Ignacio Mora

FDA vs EU Inspections – Getting Prepared and What are Differences

By Marie Dorat

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

By Mukesh Kumar

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

By Betty Lane

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

By Nancy J. Knettell

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

By Charles H Paul

Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances

By Michael Brodsky

How to Implement a Risk Management Process

By Chris Doxey

Establishing a Medical Device Reporting System Integrated with a UDI System

By David Lim

Risk Management for Medical Devices: ISO 14971:2007

By Ron Schoengold

Best Practices for Preparation for, Behavior during, and Response to an FDA Inspection

By Jeff Kasoff

Equipment Qualification and Process Validation

By Loren Gelber

21 CFR 11 Compliance for Excel Spreadsheets

By Angela Bazigos

Lyophilization and Stabilization of Proteins, Cells and Viruses

By Jeff Schwegman

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

By Kenneth Christie

Part 11 Compliance and the Role of Standard Operating Procedures

By Herman Wong

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

By Azim Chowdhury

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

By Ronald D. Snee

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

By Jerry Dalfors

Auditing API Facilities

By Igor Gorsky

Lyophilization Process Development and Cycle Design

By Jeff Schwegman

Leverage Regulatory Documentation: Write Sops That Actually Work and Have Value

By Charles H Paul

Cybersecurity Exploitation Recovery

By Casper E Uldriks

How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals

By Loren Gelber

Human Microbiome and Implications for Contamination Control

By Tim Sandle

Implementing the ASTM E2500 Validation Method

By Kelly Thomas

6-Hour Virtual Seminar on Electronic Common Technical Document (eCTD) Submissions of IND/NDA to the US FDA, EU and Canada

By Peggy J. Berry

Software Process Verification and Validation

By Dev Raheja

Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach

By Joy L McElroy

Clinical Trial Master File Compliance

By Carolyn Troiano

FDA's Regulatory Management of Your Cybersecurity Threats

By Casper E Uldriks

Medical Device Employee Training - Requirements and Implementation Tips

By Betty Lane

Effective Records Management & Document Control for Medical Devices

By Denise Wrestler

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

By Gregory Martin

In Depth Testing of Computer Systems Regulated by FDA

By Carolyn Troiano

Stunning Changes in FDA's Software Regulation

By Casper E Uldriks

Construct and Manage the Technical File and Design Dossier

By David R Dills

In Depth Testing of Computer Systems Regulated by FDA

By Carolyn Troiano

6-Hour Virtual Seminar on FDA's Moving Target and Hammer for Social Media

By Casper E Uldriks

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

By Denise Wrestler

FDA Investigations and Inspections

By Luis Chavarria

Effective Pharmaceutical GMP Audits and Self-Inspections

By Carl Patterson

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

By Laura Brown

FDA Inspection: From SOP to 483

By Jeff Kasoff

The FDA Inspection Process: From SOP to 483

By Jeff Kasoff

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

By David Lim

FDA Inspection: Preparation and Management

By David Lim

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

By Laura Brown

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

By Joy L McElroy

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

By Mukesh Kumar

Are Electronic Cigarettes a Public Health Threat or Benefit?

By Azim Chowdhury

10 Steps to Perfect SOPs: FDA Compliance made easy

By Mukesh Kumar

GMPs for Medical Marijuana Production Operations Cannabis GMP

By Charles H Paul

Improving 510(k) Submission Quality

By David Lim

Quality by Design - Essential Techniques for Medical Devices

By Susanne Manz

New FDA Guidance for Direct-to-Consumer Promotional Labeling and Advertisements

By Kelly Thomas

How to withstand an FDA audit of your facility

By Mukesh Kumar

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

By Dr Charles H Pierce

The 6 Most Common Problems in FDA Software Validation and Verification, Computer System Validation: Step-by-Step

By Carolyn Troiano

The Sunshine Act Reporting for Clinical Trials

By Mukesh Kumar

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

By David Lim

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

By David Lim

Computer System Validation

By Edwin Waldbusser

10 Steps to an FDA-Acceptable Clinical Trial Protocol

By Mukesh Kumar

Writing Effective SOP’s

By Angela Bazigos

GMP Vendor Audits

By Dr. James R Harris

Quality Management Systems for Medical Devices and IVDs

By David Lim

FDA's New Import Program for 2019

By Casper E Uldriks

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

By Edwin Waldbusser

ISO 13485 Quality Management System

By Peter Spath

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

By Joy L McElroy

Risk-based Design Control - The New Paradigm for Medical Device Design

By Jose Ignacio Mora

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

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

By David Lim

How to select Software for a Regulated Environment

By Angela Bazigos

How to justify doing less microbiological sampling and testing, and still pass a regulatory inspection

By Tim Sandle

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

By Camille Davis Thornton

cGMP for Medical Devices Including In Vitro Diagnostic Medical Devices

By David Lim

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

By Gregory Martin

Out of Specification Investigations: A New Look at the Topic

By Tim Sandle

Applying FMEA risk assessment to a sterility testing isolator

By Tim Sandle

FDA - Streamlining Your Internal Auditing Process

By Betty Lane

HIPAA Designed for the Front Office Staff

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

Applying Global Standards to Life Sciences Compliance Documentation

By Charles H Paul

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

By Tim Sandle

Secrets for Writing Excellent SOPs (Standard Operating Procedures)

By Susanne Manz

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

By Jeff Schwegman

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

By Igor Gorsky

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

By Gregory Martin

Analytical Method Validation and Transfer

By Kelly Thomas

Developing an Effective Risk Management Plan for Medical Devices

By Daniel O'Leary

Critical SOPs for Clinical Sites

By Mukesh Kumar

Equipment Validation, Tracking, Calibration and Preventive Maintenance

By Jeff Kasoff

FDA Import and Export Requirements

By Casper E Uldriks

The Problem of Bacterial Spores and Sporicidal Disinfection

By Tim Sandle

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

By David Lim

Monitoring and Validation of Pharmaceutical Water Systems

By Carl Patterson

Acceptance Activities in FDA's Quality Management System

By Daniel O'Leary

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

By Charles H Paul

Implementing a Stability Program for a Biologic

By Gwendolyn Wise-Blackman

Writing Validation Master Plans: Best Practices for Authoring a Compliant Document

By Joy L McElroy

21 CFR Part 11 Complying with: Step by Step

By Chinmoy Roy

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

By Dr Charles H Pierce

Systems Validation Made Easy

By Herman Wong

GMP Audits: Tools and Techniques

By Carl Patterson

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

By Howard T Cooper

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

By Tim Sandle

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

By Harry Huss

510(k): Submission and Clearance

By David Lim

Process Validation – Principles and Protocols

By Jeff Kasoff

Steam Sterilization Microbiology and Autoclave Performance Qualification

By Danielle DeLucy

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

By Charlie Sodano

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

By Walter E. Murray

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

By Mukesh Kumar

Establishing a Compliant and Effective Change Control Program

By Kelly Thomas

Fungal Contamination and Pharmaceutical Products Recall

By Tim Sandle

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

By Gregory Martin

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

By David Lim

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

By Edwin Waldbusser

Project Management for Computer Systems Validation

By Angela Bazigos

Creating and maintaining an effective and efficient Technical Training program

By Dr. Ginette M. Collazo

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

By Mukesh Kumar

Problem Solving - Root Cause Analysis in Pharma Manufacturing

By Joy L McElroy

21 CFR Part 11 - Electronic Record and Signature Validation

By Edwin Waldbusser

Approaches to Improve Regulatory Information Policies and Procedures

By Charlie Sodano

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

By Betty Lane

FDA's Off-label Promotion in Social Media

By Casper E Uldriks

Current Concepts & Challenges in Cloud Compliance

By Angela Bazigos

The Problem of Bacterial Spores and Sporicidal Disinfection

By Tim Sandle

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

By Salma Michor

Quality SOPs: Guidelines to developing and writing FDA Compliant Documents

By Chitra Edwin

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

By Norma Skolnik

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

By Joy L McElroy

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

By David R Dills

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

By Carolyn Troiano

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

By Mukesh Kumar

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

By Charlie Sodano

Developing a contamination control strategy to meet EU GMP Annex 1 requirements

By Tim Sandle

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

By David Lim

Handling data integrity in the microbiology laboratory

By Tim Sandle

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

By Jeff Kasoff

Good Design Practices For Pharmaceutical Water Systems

By Tim Sandle

Is it Method Verification or Validation, or Just Semantics?

By Michael Brodsky

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

By Jeff Schwegman

21 CFR Part 11 - Electronic Record and Signature Validation

By Edwin Waldbusser

Changes in FDA's Device Corrections and Removals Reporting

By Casper E Uldriks

Technical Writing in an Industrial Environment

By Robert Peoples

Establish and Maintain an Effective Supplier Qualification Program

By David R Dills

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

By Dr. James R Harris

Testing Medical Devices for Efficiency and Efficacy

By Dev Raheja

Implementing Design control for Medical Devices and IVDs

By David Lim

The Human Error Tool Box: A Practical Approach to Human Error

By Dr. Ginette M. Collazo

Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ

By Susanne Manz

Step-by-Step Process for Successful Sterility Failure Investigations

By Danielle DeLucy

IRB and Other Committees

By Richard L. Chamberlain

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

By David Lim

Fungal Contamination and Pharmaceutical Products Recall

By Tim Sandle

Sample Quality Control for Molecular Diagnostics

By Todd Graham

FDA - Streamlining Your Internal Auditing Process

By Betty Lane

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

By David Lim

FDA Rules for using Social Media for Marketing Prescription Products

By Mukesh Kumar

Practical Guide to FDA Inspections

By Casper E Uldriks

Technical Writing Best Practices

By Robert Peoples

Qualification of Contract Manufacturer Organizations Based on Practical Experience

By Edwin Waldbusser

Complaint Management: Best Practices to Assure Customer Retention

By Jeff Kasoff

ISO 14644 - The Revised Standard and Implications for Cleanrooms

By Tim Sandle

Designing And Implementing The Quality System From Scratch

By Howard T Cooper

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

By Camille Davis Thornton

Internal GMP Audits

By Dr. James R Harris

Best practices for designing and implementing an environmental monitoring programme

By Tim Sandle

Controlling Human Error on the Manufacturing Floor

By Dr. Ginette M. Collazo

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

By Jose Ignacio Mora

FDA's Off-label Promotion in Social Media

By Casper E Uldriks

How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records

By Carolyn Troiano

Reducing Memory and Attention Failures/Errors: Cognitive Load Assessment

By Dr. Ginette M. Collazo

Test Method Validation to Verify your Device Performance

By Jose Ignacio Mora

Scale Up and Cycle Transfer for Lyophilization Cycles

By Jeff Schwegman

Container – Closure Systems for Lyophilized Products

By Jeff Schwegman

Implementing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

By Kelly Thomas

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

By Michael Esposito

The New EU Medical Device Regulation

By Salma Michor

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

By Dr Charles H Pierce

Overview of the Mexican Labeling Standards and the New Labeling Requirements

By Esther Diaz

Regulatory and Testing Requirements of the Bacterial Endotoxin Testing (BET) or LAL Program

By Carl Patterson

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

By Gregory Martin

Generation of Controlled Documents and Related Training

By Jerry Dalfors

How to Develop Quality Systems for New Diagnostic Assays

By Todd Graham

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

By Denise Wrestler

In-Depth Testing of Computer Systems Regulated by FDA

By Carolyn Troiano

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

By Mukesh Kumar

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

By David Lim

Data Governance for Computer Systems Regulated by FDA

By Carolyn Troiano

Preventing Human Error in the Life Sciences

By Charles H Paul

Preparing for FDA BIMO Inspection and Management

By David Lim

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

By David Lim

Use GAMP to Surefire your CSV Audit

By Chinmoy Roy

Establishing a Robust Supplier Management Program

By Kelly Thomas

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

By Dr. Ginette M. Collazo

Understanding the Brazilian Regulatory Environment for Medical Devices

By Claudia De Lucca Mano

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

By Joy L McElroy

Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical Manufacturing

By Carl Patterson

Comparing the Pharmaceutical and Medical Device Lifecycles

By Howard T Cooper

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

By David Lim

Bonified CAPA Investigations

By Walter E. Murray

IEC 62304: Medical Device Software Development and Validation

By Chinmoy Roy

FDA Inspection and Medical Device Design Control

By David Lim

Data Governance for Computer Systems Regulated by FDA

By Carolyn Troiano

Cleaning Validations Using Extraction Techniques

By Kierstan Andrascik

Implementing Medical Device Reporting

By David Lim

Managing the FDA form "483": Inspection Observations

By Casper E Uldriks

Good Documentation Guideline (Chapter 1029 USP)

By Dr. Afsaneh Motamed Khorasani

How FDA Inspection Observations are Reviewed for Regulatory Action

By Luis Chavarria

Bulletproofing your cGXP Documentation from Audit Citations

By Chinmoy Roy

FDA Warning Letter Management

By Casper E Uldriks

FDA Rules for Trial Master Files

By Mukesh Kumar

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

By Mercedes Massana

GMP Quality Principles

By Dr. James R Harris

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

By Mukesh Kumar

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

By Edwin Waldbusser

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

By Dr. Nagina Parmar

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

By Carl Patterson

Quality Control of Raw Materials (APIs and Excipients)

By Peggy J. Berry

Advertising and Promotional Material Compliance and Review Process

By Peggy J. Berry

Developing an Effective CAPA Management and Root Cause Analysis System

By Danielle DeLucy

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

By David Lim

ICH-FDA Good Clinical Practice – Managing Clinical Trials

By Marie Dorat

Tools for Human Error Reduction: Developing Metrics and KPI's (Key Performance Indicators) to minimize Human error rates

By Dr. Ginette M. Collazo

Responsibility for Off-label Claims in Social Media

By Casper E Uldriks

Control of Cleanroom Garments and Supplies: Contamination Control

By Tim Sandle

IQ, OQ, PQ in the Verification and Validation Process

By Susanne Manz

Equipment Qualification and Process Validation

By Loren Gelber

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

By Michael Esposito

Risk Based Clinical Trial Monitoring

By Laura Brown

Implementing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

By Susanne Manz

How to Write Error Free and FDA Compliant Procedures

By Dr. Ginette M. Collazo

Draft Guidance for Device Industry and FDA - Postmarket Surveillance

By David R Dills

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

By Casper E Uldriks

Cybersecurity Exploitation Recovery

By Casper E Uldriks

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

By Joy L McElroy

Managing Foreign Inspections - Before, During and After

By Casper E Uldriks

10 Steps to Perfect SOPs: FDA Acceptable SOPs made Easy

By Mukesh Kumar

Stability Studies and Estimating Shelf Life with Regression Models

By Steven Wachs

Implementing a Change Control Quality System Successfully

By Danielle DeLucy

Laboratory Controls – Anticipate the Systems Based FDA Inspection

By Danielle DeLucy

Establishing a Compliant and Effective Change Control Program

By Kelly Thomas

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

By Mukesh Kumar

Understanding Combination Products: Navigating the Rules and Regulations

By Charles H Paul

Bad Standard Operating Procedures (SOPs) - Bad Training: Garbage In, Garbage Out

By Michael Esposito

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

By Jeff Kasoff

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

By Jose Ignacio Mora

Stunning Changes in FDA's Software Regulation

By Casper E Uldriks

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

By David Lim

Recent cGMP Violations and How to Avoid Citations

By Dr. James R Harris

510(k): Format, Contents and Case Studies

By David Lim

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

By Lamont M. Fulton

Human Error Reduction in GMP Related Environments

By Dr. Ginette M. Collazo

Practical Approaches to Sterility Test Validation: Overcoming difficult products

By Tim Sandle

Managing Documents, Records, and Data for FDA Inspections

By Susanne Manz

Quality system requirements for cleaning, maintenance and calibration programs

By Kenneth Christie

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