Webinars

Process Validation Requirements and Compliance Strategies
José Mora

Process Validation Requirements and Compliance Strategies

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
Roger Cowan

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

Genotoxic Impurities in Drug Development
Dr. Stefano Persiani

Genotoxic Impurities in Drug Development

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

Pharmaceutical Water Systems
Carl Patterson

Pharmaceutical Water Systems

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

Technical Writing- Best Practices For Everyday Use
Robert Peoples

Technical Writing- Best Practices For Everyday Use

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

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

510(k) and PMA Refuse to Accept Policy

Risk Management for Medical Devices and IVD product
Richard Young

Risk Management for Medical Devices and IVD product

Zero Acceptance Sampling Plans to Reduce Inspection Costs
William Levinson

Zero Acceptance Sampling Plans to Reduce Inspection Costs

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

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

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

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Roger Cowan

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

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

How Home Healthcare is Changing the Medical Device Game
Tom KraMer

How Home Healthcare is Changing the Medical Device Game

Biomarkers in Drug Discovery and Development
Dr. Stefano Persiani

Biomarkers in Drug Discovery and Development

Bulletproof CAPA Process- How to do it Right
Yuval Shapiro

Bulletproof CAPA Process- How to do it Right

ISO13485- Quality Management Systems for Medical Devices
Yuval Shapiro

ISO13485- Quality Management Systems for Medical Devices

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