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Upcoming Webinar
On-Demand webinar
Applying Global Standards to Life Sciences Compliance Documentation
By Charles H Paul
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Date: Tuesday, 17 December 2019
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Duration: 60 Minutes
FDA's Off-label Promotion in Social Media
By Casper E Uldriks
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Date: Wednesday, 18 December 2019
|
Duration: 60 Minutes
Load More Live Webinar
The Basic Requirements for Developing IQ and OQ Protocols
By Kenneth Christie
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
How to Conduct an Effective Annual Product Quality Review
By Danielle DeLucy
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
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration
By Jose Ignacio Mora
Best Practices for Preparation for, Behavior during, and Response to an FDA Inspection
By Jeff Kasoff
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
Manufacturing Quality Agreements- Qualifying Suppliers & Managing Quality in FDA-Regulated Industries
By Joy L McElroy
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
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
Measurement Uncertainty for Calibration and Testing Laboratories
By Michael Brodsky
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
System Suitability Testing in the Pharmaceutical Laboratory: Addressing FDA and USP Compliance
By Gregory Martin
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
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
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
Managing the FDA form "483": Inspection Observations
By Casper E Uldriks
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
Best Practices for Implementing an Effective Cleaning Validation (Using Principles of Upcoming ASTM E3106)
By Igor Gorsky
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
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's Medical Device De Novo Reclassification Process
By Charles H Paul
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
Complaint Handling and Medical Device Reporting
By Susanne Manz
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
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
By Carolyn Troiano
FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS
By Joy L McElroy
FDA Internal Complaint Handling
By Kelly Thomas
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
Writing Effective Standard Operating Procedures and Work Instructions
By Charles H Paul
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
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
Analytical Instrument Qualification - Practical Approaches for Revised USP General Chapter 1058 Compliance
By Gregory Martin
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
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
Strategies to Combat Counterfeit Drugs and Other Supply Chain Threats
By Michael Esposito
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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