Webinars

EU-US biosimilar regulations - similarities and differences
Peter Wittner

EU-US biosimilar regulations - similarities and differences

Compliance with the new EU Clinical Trial Regulation
Dr Laura Brown

Compliance with the new EU Clinical Trial Regulation

Technical Writing- A Detailed Process
Robert Peoples

Technical Writing- A Detailed Process

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
Dr Laura Brown

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

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

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

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

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

Data Integrity and Governance for Computer Systems Regulated by FDA
Carolyn Troiano

Data Integrity and Governance for Computer Systems Regulated by FDA

The FDA Inspection Process- From SOP to 483
Jeff Kasoff

The FDA Inspection Process- From SOP to 483

Process Failure Mode Effects Analysis and Control Plan
William Levinson

Process Failure Mode Effects Analysis and Control Plan

Risk Management for Medical Devices and IVD product
Richard Young

Risk Management for Medical Devices and IVD product

Is it Microbiological Method Verification or Validation, or Just Semantics
Michael Brodsky

Is it Microbiological Method Verification or Validation, or Just Semantics

How FDA Trains Its investigators To Review CAPA and What You Should Do To prepare
Jeff Kasoff

How FDA Trains Its investigators To Review CAPA and What You Should Do To prepare

Technical Writing- A Detailed Process
Robert Peoples

Technical Writing- A Detailed Process

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

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

Bulletproof CAPA Process- How to do it Right
Yuval Shapiro

Bulletproof CAPA Process- How to do it Right

Best Practices in Preparation for an FDA Computer System Audit
Carolyn Troiano

Best Practices in Preparation for an FDA Computer System Audit

An Advanced Course on Lean Documents, Lean Configuration and Document Control
José Mora

An Advanced Course on Lean Documents, Lean Configuration and Document Control

Technical Writing- Best Practices For Everyday Use
Robert Peoples

Technical Writing- Best Practices For Everyday Use

Sterilization of Pharmaceutical Products and Medical Devices
Carl Patterson

Sterilization of Pharmaceutical Products and Medical Devices

The Rush for ISO13485- 2016
Yuval Shapiro

The Rush for ISO13485- 2016

Top Process Validation Mistakes - And How to Avoid Them
Susanne Manz

Top Process Validation Mistakes - And How to Avoid Them

ANDA Submission and GDUFA Guidance
Charles H Paul

ANDA Submission and GDUFA Guidance

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

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

How Home Healthcare is Changing the Medical Device Game
Tom KraMer

How Home Healthcare is Changing the Medical Device Game

Pharmaceutical Water Systems
Carl Patterson

Pharmaceutical Water Systems

Training for New Technical Writers
Robert Peoples

Training for New Technical Writers

Onboarding New or Transferred Employees in a GMP Environment
Michael Esposito

Onboarding New or Transferred Employees in a GMP Environment

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
Roger Cowan

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards
Roger Cowan

Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards

Medical Device Cyber-security following latest FDA Guidance
Edwin Waldbusser

Medical Device Cyber-security following latest FDA Guidance

Organizational Change Management for FDA Regulated Computer Systems
Carolyn Troiano

Organizational Change Management for FDA Regulated Computer Systems

The Importance of Packaging and Labeling in Pharmaceutical Production – Best Practices
Michael Esposito

The Importance of Packaging and Labeling in Pharmaceutical Production – Best Practices

Quality Risk Management Overview
Steven Laurenz

Quality Risk Management Overview

Genotoxic Impurities in Drug Development
Dr. Stefano Persiani

Genotoxic Impurities in Drug Development

Process Validation Requirements and Compliance Strategies
José Mora

Process Validation Requirements and Compliance Strategies

510(k) and PMA Refuse to Accept Policy
Mr.Charles H Paul

510(k) and PMA Refuse to Accept Policy

Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
Roger Cowan

Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements

Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
David Nettleton

Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

USP 1224- Transferring the Method to meet Regulatory Expectations
Carl Patterson

USP 1224- Transferring the Method to meet Regulatory Expectations

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Carolyn Troiano

Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

Biomarkers in Drug Discovery and Development
Dr. Stefano Persiani

Biomarkers in Drug Discovery and Development

US Biosimilar Regulations, Barriers and FDA Expectations
Peter Wittner

US Biosimilar Regulations, Barriers and FDA Expectations

Pharmacovigilance Auditing and Inspections
Michael Ramcharan

Pharmacovigilance Auditing and Inspections

Computer System Validation (CSV) vs Computer Software Assurance (CSA) as an Approach to Meeting FDA Compliance
Carolyn Troiano

Computer System Validation (CSV) vs Computer Software Assurance (CSA) as an Approach to Meeting FDA Compliance

ISO13485- Quality Management Systems for Medical Devices
Yuval Shapiro

ISO13485- Quality Management Systems for Medical Devices

Writing Effective SOPs for the Medical Device and Pharmaceutical Industries
Carl Patterson

Writing Effective SOPs for the Medical Device and Pharmaceutical Industries

Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities
Mr.Charles H Paul

Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities

GMP Environmental Monitoring in Pharmaceutical Clean Rooms
Roger Cowan

GMP Environmental Monitoring in Pharmaceutical Clean Rooms

Zero Acceptance Sampling Plans to Reduce Inspection Costs
William Levinson

Zero Acceptance Sampling Plans to Reduce Inspection Costs