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About us
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HR Compliance
BFSI
Life Sciences
Health Care
Chronicles
All Chronicle
HR Compliance
BFSI
Life Sciences
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Blog
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Webinars
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Webinars
Peter Wittner
EU-US biosimilar regulations - similarities and differences
Dr Laura Brown
Compliance with the new EU Clinical Trial Regulation
Robert Peoples
Technical Writing- A Detailed Process
Dr Laura Brown
Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP
José Mora
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
Michael Brodsky
Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances
Carolyn Troiano
Data Integrity and Governance for Computer Systems Regulated by FDA
Jeff Kasoff
The FDA Inspection Process- From SOP to 483
William Levinson
Process Failure Mode Effects Analysis and Control Plan
Richard Young
Risk Management for Medical Devices and IVD product
Michael Brodsky
Is it Microbiological Method Verification or Validation, or Just Semantics
Jeff Kasoff
How FDA Trains Its investigators To Review CAPA and What You Should Do To prepare
Robert Peoples
Technical Writing- A Detailed Process
José Mora
Risk-based Design Control - The New Paradigm for Medical Device Design
Yuval Shapiro
Bulletproof CAPA Process- How to do it Right
Carolyn Troiano
Best Practices in Preparation for an FDA Computer System Audit
José Mora
An Advanced Course on Lean Documents, Lean Configuration and Document Control
Robert Peoples
Technical Writing- Best Practices For Everyday Use
Carl Patterson
Sterilization of Pharmaceutical Products and Medical Devices
Yuval Shapiro
The Rush for ISO13485- 2016
Susanne Manz
Top Process Validation Mistakes - And How to Avoid Them
Charles H Paul
ANDA Submission and GDUFA Guidance
José Mora
Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration
Tom KraMer
How Home Healthcare is Changing the Medical Device Game
Carl Patterson
Pharmaceutical Water Systems
Robert Peoples
Training for New Technical Writers
Michael Esposito
Onboarding New or Transferred Employees in a GMP Environment
Roger Cowan
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
Roger Cowan
Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards
Edwin Waldbusser
Medical Device Cyber-security following latest FDA Guidance
Carolyn Troiano
Organizational Change Management for FDA Regulated Computer Systems
Michael Esposito
The Importance of Packaging and Labeling in Pharmaceutical Production – Best Practices
Steven Laurenz
Quality Risk Management Overview
Dr. Stefano Persiani
Genotoxic Impurities in Drug Development
José Mora
Process Validation Requirements and Compliance Strategies
Mr.Charles H Paul
510(k) and PMA Refuse to Accept Policy
Roger Cowan
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
David Nettleton
Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
Carl Patterson
USP 1224- Transferring the Method to meet Regulatory Expectations
Carolyn Troiano
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance
Dr. Stefano Persiani
Biomarkers in Drug Discovery and Development
Peter Wittner
US Biosimilar Regulations, Barriers and FDA Expectations
Michael Ramcharan
Pharmacovigilance Auditing and Inspections
Carolyn Troiano
Computer System Validation (CSV) vs Computer Software Assurance (CSA) as an Approach to Meeting FDA Compliance
Yuval Shapiro
ISO13485- Quality Management Systems for Medical Devices
Carl Patterson
Writing Effective SOPs for the Medical Device and Pharmaceutical Industries
Mr.Charles H Paul
Complaint Handling Requirements – Interrelationship with CAPA, Change Control, Adverse Event Reporting and Recalls, Life Cycle Process Activities
Roger Cowan
GMP Environmental Monitoring in Pharmaceutical Clean Rooms
William Levinson
Zero Acceptance Sampling Plans to Reduce Inspection Costs
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