Toggle navigation
Toll Free: +1-510-857-5896
/
Login
/
Sign Up
-
0
Webinars
Package Training
Partner Courses
Industry
Resources
Articles
About Us
Affiliate
Membership
Home
Industry
Life Sciences
Life Sciences
Upcoming Webinar
On-Demand webinar
Manage Your FDA Inspection Before It Happens
By Casper E Uldriks
|
Date: Wednesday, 20 February 2019
|
Duration: 60 Minutes
Controlling Human Error on the Manufacturing Floor
By Dr. Ginette M. Collazo
|
Date: Tuesday, 26 February 2019
|
Duration: 90 Minutes
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - Principles of Lean Documents and Lean Configuration
By Jose Ignacio Mora
|
Date: Tuesday, 26 February 2019
|
Duration: 90 Minutes
The Problem of Bacterial Spores and Sporicidal Disinfection
By Tim Sandle
|
Date: Thursday, 21 February 2019
|
Duration: 60 Minutes
Practical Strategies for Compliance with USP 800: Hazardous Drug Compliance and Safety in 2019
By Igor Gorsky
|
Date: Wednesday, 27 February 2019
|
Duration: 90 Minutes
Production and Process Controls - Ensuring Your Medical Device Conforms to its Specifications
By Denise Wrestler
|
Date: Wednesday, 27 February 2019
|
Duration: 60 Minutes
Equipment Validation, Tracking, Calibration and Preventive Maintenance
By Jeff Kasoff
|
Date: Thursday, 21 February 2019
|
Duration: 60 Minutes
Classifying Medical Devices, The De Novo Process and the FDA's Final Rule to Simplify Medical Device Classification Procedures
By Charles H Paul
|
Date: Thursday, 21 February 2019
|
Duration: 60 Minutes
Load More Live Webinar
IQ, OQ, PQ in the Verification and Validation Process
By Kenneth Zabel
FDA Good Laboratory Practice (GLP) Inspection Preparation and Management: Dos and Don’ts
By David Lim
Draft Guidance for Device Industry and FDA - Postmarket Surveillance
By David R Dills
Improving 510(k) Submission Quality
By David Lim
ISO 13485 Quality Management System
By Peter Spath
The Basic Requirements for Developing IQ and OQ Protocols
By Kenneth Christie
Medical Device Laws and Regulations in China, Hong Kong, Japan and Korea
By David Lim
The FDA Inspection Process: From SOP to 483
By Jeff Kasoff
Establish and Maintain an Effective Supplier Qualification Program
By David R Dills
Effective Pharmaceutical GMP Audits and Self-Inspections
By Carl Patterson
Medical Device Compliance with MEDDEV 2.7.1 Rev 4 for Clinical Evaluation / CER Reporting
By Salma Michor
Lyophilization and Stabilization of Proteins, Cells and Viruses
By Jeff Schwegman
FDA Regulatory Control of the Drug Development Process and Investigator Responsibility in the Process
By Dr Charles H Pierce
Auditing for 21 CFR Part 11
By Herman Wong
Creating a Good Design History File (DHF) for Audit Success
By Mercedes Massana
Implementing a Stability Program for a Biologic
By Gwendolyn Wise-Blackman
Equipment Qualification and Process Validation
By Loren Gelber
Approaches to Improve Regulatory Information Policies and Procedures
By Charlie Sodano
QSR-Compliant Equipment Control & Validation of Processes in the Manufacturing Environment
By Joy McElroy
Preparing for FDA Inspection and Management including GLP Inspection: Best Practices
By David Lim
Improved Generic Drugs via the 505(b)(2) Regulatory Pathway: FDA Approval Made Easy
By Mukesh Kumar
Use GAMP to Surefire your CSV Audit
By Chinmoy Roy
Stunning Changes in FDA's Software Regulation
By Casper E Uldriks
Quality system requirements for cleaning, maintenance and calibration programs
By Kenneth Christie
How to Prepare for and Host a FDA Inspection and Avoid 483's
By Edwin Waldbusser
Why is Liver Injury (DILI) the Most Frequent Reason for a Drug Being Pulled from the Market
By Dr Charles H Pierce
EU GMP Annex 1 - What's New for Sterile Product Manufacturing?
By Tim Sandle
The Hitchhiker's Guide to 483s and Warning Letters
By Angela Bazigos
FDA Approval of Adaptive Clinical Trials: Practical Tips to Maximize Benefits from Smart Trial Design
By Mukesh Kumar
HIPAA Designed for the Front Office Staff
By Rhonda Granja, B.S., CMC, CMOM, CMA, CPC
Investigator initiated trials- What are we doing to ensure human subject protection?
By Dr. Nagina Parmar
510(k) Submission: Contents and Format for Medical Devices
By David Lim
Implementing the ASTM E2500 Validation Method
By Kelly Thomas
FDA Warning Letter Management
By Casper E Uldriks
Applying Global Standards to Life Sciences Compliance Documentation
By Charles H Paul
Submitting FDA Electronic Regulatory Filings – Drug Establishment Registrations and Drug Listings
By Camille Davis Thornton
Acceptance Sampling Plans for Process Validation and Production Lot Monitoring
By Steven Wachs
Trial Master File (TMF): FDA Expectations from Sponsors and Sites
By Mukesh Kumar
Establishing a Robust Supplier Management Program
By Kelly Thomas
Construct and Manage the Technical File and Design Dossier
By David R Dills
How to select Software for a Regulated Environment
By Angela Bazigos
Comparing the Pharmaceutical and Medical Device Lifecycles
By Howard T Cooper
Quality SOPs: Guidelines to developing and writing FDA Compliant Documents
By Chitra Edwin
EU Medical Device Directive: Preparing for Conformity Assessment Application for CE Marking of Medical Devices
By David Lim
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer
By Gregory Martin
Best Practices for Purchasing and Supplier Controls in the Medical Device Industry
By Jeff Kasoff
Step-by-Step Process for Successful Sterility Failure Investigations
By Danielle DeLucy
ISO 14644 - The Revised Standard and Implications for Cleanrooms
By Tim Sandle
Optimized Formulation Development for Lyophilized Products
By Jeff Schwegman
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
By Jose Ignacio Mora
Cybersecurity Exploitation Recovery
By Casper E Uldriks
Risk Management for Medical Devices: ISO 14971:2007
By Ron Schoengold
Good Design Practices For Pharmaceutical Water Systems
By Tim Sandle
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer
By Gregory Martin
Recent cGMP Violations and How to Avoid Citations
By Dr. James R Harris
Computer System and Software Validation
By Peter Spath
Is it Method Verification or Validation, or Just Semantics?
By Michael Brodsky
FDA's New Guideline regarding Contract Manufacturing Arrangements for Drugs: QUALITY AGREEMENTS
By Dr. James R Harris
Risk Assessment in Cleaning Validation
By Igor Gorsky
Fungal Contamination and Pharmaceutical Products Recall
By Tim Sandle
A Regulatory Perspective: FDA's New Guidance's Deciding When to Submit a 510(k) for Device & Software Changes
By Carolyn Troiano
Good Practices for an FDA Inspection Preparation and Readiness: Dos and Don'ts
By David Lim
FDA Inspection and Medical Device Design Control
By David Lim
Good Documentation Guideline (Chapter 1029 USP)
By Dr. Afsaneh Motamed Khorasani
Medical Device Employee Training - Requirements and Implementation Tips
By Betty Lane
Burkholderia cepacia - Risks in Context for Non-Sterile Pharmaceutical Products
By Tim Sandle
The Sunshine Act Reporting for Clinical Trials
By Mukesh Kumar
Effective Root Cause Analysis: The Key to an Effective Corrective Actions System
By Betty Lane
Onboarding Employees in a GMP Environment: Best Practices for Foundational Employee Success
By Michael Esposito
Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
By Gregory Martin
Hazard Analysis Following ISO 14971
By Edwin Waldbusser
What to identify? Why Screening Cleanroom Microbes Matters
By Tim Sandle
Import of FDA Regulated Products into the US: FDA and Customs Requirements at the Port of Entry
By Dr. Rossano V. Gerald
510(k): Regulatory and Technical Requirements Compliant with eCopy and RTA Policy
By David Lim
How to Write Procedures to Avoid Human Errors
By Dr. Ginette M. Collazo
Overview of the Mexican Labeling Standards and the New Labeling Requirements
By Esther Diaz
How To Conduct a Successful Process Validation
By Dr. James R Harris
New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines
By Gregory Martin
cGMP for Medical Devices Including In Vitro Diagnostic Medical Devices
By David Lim
GMP Vendor Audits
By Dr. James R Harris
FDA BIMO Inspection: Preparation and Management: Dos and Don'ts
By David Lim
Writing and Enforcing Effective SOPs
By David R Dills
Acceptance Activities in FDA's Quality Management System
By Daniel O'Leary
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
By Dr. Ginette M. Collazo
Control of Cleanroom Garments and Supplies: Contamination Control
By Tim Sandle
IQ, OQ, PQ in the Verification and Validation Process
By Susanne Manz
How to withstand an FDA audit of your facility
By Mukesh Kumar
Good Documentation Guideline (Chapter 1029 USP)
By Dr. Afsaneh Motamed Khorasani
The DIOM - A Straightforward Method for Meeting FDA Requirements for Design Inputs and Outputs
By Denise Wrestler
Compliant Management Controls Under 21 CFR 820 and ISO 13485
By Jeff Kasoff
Update: Medical Device Laws and Regulations in China, Hong Kong, Japan and Korea
By David Lim
Understanding Freezing, Annealing, Primary and Secondary Drying in the Freeze-Drying Process
By Jeff Schwegman
General Data Protection Regulation (GDPR): Compliance for Clinical Trials
By Laura Brown
Role of Logbooks and Recordkeeping in Identifying Root Causes in Labs
By John Fetzer
FDA Auditing Practices and the Top 10 Most Common Cited GMP Deficiencies
By Kenneth Christie
FDA's Off-label Promotion in Social Media
By Casper E Uldriks
FDA Inspection: Preparation and Management
By David Lim
Are Electronic Cigarettes a Public Health Threat or Benefit?
By Azim Chowdhury
Designing And Implementing The Quality System From Scratch
By Howard T Cooper
IND Submission for a 505(b)(2) Product
By Mukesh Kumar
21 CFR 11 Compliance for Excel Spreadsheets
By Angela Bazigos
Laboratory Safety: Efficient Environmental, Health and Safety (EHS) Management
By Dr. Vince Marchesani
Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
By Jose Ignacio Mora
CMC Requirements for Cell and Gene Therapy
By Gwendolyn Wise-Blackman
GMP Quality Principles
By Dr. James R Harris
Testing Medical Devices for Efficiency and Efficacy
By Dev Raheja
Determining a Regulatory Pathway for your Over-the-Counter (OTC) Drug Product
By Camille Davis Thornton
Successful 510(k) Documentation for Software or Software Containing Medical Devices
By Nancy J. Knettell
Software Process Verification and Validation
By Dev Raheja
Through the Eyes of an Auditor
By Jose Ignacio Mora
Part 11 Compliance and the Role of Standard Operating Procedures
By Herman Wong
Off-Label Uses of Medical Products Under FDA Rules: Walking the Fine Line of Promotion Verses Scientific Discussion
By Mukesh Kumar
FDA's Medical Device De Novo Reclassification Process
By Charles H Paul
21 CFR Part 11 Complying with: Step by Step
By Chinmoy Roy
Establishing a Medical Device Reporting System Integrated with a UDI System
By David Lim
Computer System Validation
By Edwin Waldbusser
Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts
By Harry Huss
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
By Carolyn Troiano
FDA - Streamlining Your Internal Auditing Process
By Betty Lane
Do's and Don'ts during FDA Inspections
By Jeff Kasoff
GMP's for Medical Marijuana - Insight into Manufacturing, Labeling, Tracking and Disposal requirements
By Charles H Paul
Key Factors to Write an Effective Standard Operating Procedures (SOP) and Work Instructions (WI)
By Joy McElroy
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?
By Dr Charles H Pierce
Software Validation & Testing - Regulatory Requirements
By Dev Raheja
FDA Premarket Application Pathways for E-Cigarettes and Other New Tobacco Products
By Azim Chowdhury
CAPA Simplified - A One-Form, Easy-To-Complete, Method for Simplifying Your CAPA Process
By Denise Wrestler
Current Concepts & Challenges in Cloud Compliance
By Angela Bazigos
FDA Rules for using Social Media for Marketing Prescription Products
By Mukesh Kumar
Practical Guide to FDA Inspections
By Casper E Uldriks
Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter
By Jeff Kasoff
Understanding the Brazilian Regulatory Environment for Medical Devices
By Claudia De Lucca Mano
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
Thermal Characterization as Part of an Empirical Process for Developing Optimized Formulations and Lyophilization Cycles
By Jeff Schwegman
In Depth Testing of Computer Systems Regulated by FDA
By Carolyn Troiano
FDA 510(k): Trends, Hurdles, Submission and Clearance
By David Lim
Overview of FDA Regulations for Drugs, Biologics and Medical Devices including IVDs
By David Lim
GMP Audits: Tools and Techniques
By Carl Patterson
Implementing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
By Kelly Thomas
Human Microbiome and Implications for Contamination Control
By Tim Sandle
Safe Drinking Water-Another Oxymoron?
By Michael Brodsky
Changes in FDA's Device Corrections and Removals Reporting
By Casper E Uldriks
Best Practices for MDRs, Recalls, Corrections, and Removals
By David Lim
How to Prepare for FDA Inspections and Customer Audits of Pharmaceuticals
By Loren Gelber
Onboarding Employees In A GMP Environment: Best Practices For Foundational Employee Success
By Michael Esposito
Writing US FDA-acceptable Clinical Trial Protocols
By Mukesh Kumar
Stability Studies and Estimating Shelf Life
By Steven Wachs
FDA Rules for Trial Master Files
By Mukesh Kumar
The New EU Medical Device Regulation
By Salma Michor
Cleaning Validations Using Extraction Techniques
By Kierstan Andrascik
Preparing for an FDA Audit of your facility
By Mukesh Kumar
IRB and Other Committees
By Richard L. Chamberlain
FDA's Off-label Promotion in Social Media
By Casper E Uldriks
Technical Writing in an Industrial Environment
By Robert Peoples
Implementing Design control for Medical Devices and IVDs
By David Lim
Advertising and Promotional Material Compliance and Review Process
By Peggy J. Berry
Implementing Medical Device Reporting
By David Lim
Scale Up and Cycle Transfer for Lyophilization Cycles
By Jeff Schwegman
Generation of Controlled Documents and Related Training
By Jerry Dalfors
The Problem of Bacterial Spores and Sporicidal Disinfection
By Tim Sandle
Lyophilization Process Development and Cycle Design
By Jeff Schwegman
Project Management for Computer Systems Validation
By Angela Bazigos
Preparing for FDA BIMO Inspection and Management
By David Lim
Implementing an Internal Audit Program Pursuant to ISO 13485 and 21 CFR Part 820
By David Lim
Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>
By Gregory Martin
Efficient and Effective Batch Record Reviews to Improve your Process Capabilities
By Danielle DeLucy
Medical Device Single Audit Program (MDSAP) - All You Need To Know
By Walter E. Murray
Writing Effective SOP’s for Quality Professionals: Best Practices for Life Science Companies
By Joy McElroy
Adverse Event Reporting Compliance; The Key to Safe Drug Development / Subject Safety
By Dr Charles H Pierce
3-hr Virtual Seminar: Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)
By Howard T Cooper
FDA Import and Export Requirements
By Casper E Uldriks
Best Practices for Implementing an Effective Cleaning Validation using Principles of Upcoming ASTM E3106
By Igor Gorsky
Writing Effective SOP’s
By Angela Bazigos
ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements
By Betty Lane
Bonified CAPA Investigations
By Walter E. Murray
FDA Investigations and Inspections
By Luis Chavarria
Creation of DHFs, DMRs, and DHRs utilizing the principles of Lean Documents and Lean Configuration
By Jose Ignacio Mora
Post Approval Risk Management Strategy
By Peter Spath
How to Translate Academic and Discovery Assays into GLP Compliant Assays
By Todd Graham
Process Validation – Principles and Protocols
By Jeff Kasoff
Microbiological and Business Risk of Not Testing Raw Materials for Microbial Presence
By Carl Patterson
21 CFR Part 11 - Electronic Record and Signature Validation
By Edwin Waldbusser
Establishing a Compliant and Effective Change Control Program
By Kelly Thomas
Records Preservation Strategies that will Assure Authentication
By Charlie Sodano
Sampling - How Large a Sample Do I Need? Determining the Right Size for Accurate, Cost Effective Results
By Ronald D. Snee
Dietary Supplements and Nutraceuticals: Compliance with FDA's Current Manufacturing Requirements
By Mukesh Kumar
Record Retention - Long Enough or Too Long? A practical Guide
By Charlie Sodano
How to Implement a Risk Management Process
By Chris Doxey
Managing Documents, Records, and Data for FDA Inspections
By Susanne Manz
Problem Solving - Root Cause Analysis in Pharma Manufacturing
By Joy McElroy
10 Steps to an FDA-Acceptable Clinical Trial Protocol
By Mukesh Kumar
Developing an Effective Risk Management Plan for Medical Devices
By Daniel O'Leary
Internal GMP Audits
By Dr. James R Harris
CAPA Training and Causes of Warning Letters due to Lack of Comprehension
By Jerry Dalfors
Stability Studies and Estimating Shelf Life with Regression Models
By Steven Wachs
ICH-FDA Good Clinical Practice – Managing Clinical Trials
By Marie Dorat
USDA GMO Labeling - What to Expect from the 2018 Final Rule
By Norma Skolnik
Bulletproofing your cGXP Documentation from Audit Citations
By Chinmoy Roy
Best Practices Compliant with the FDA Regulations for Handling Medical Device Complaints
By David Lim
Risk Based Clinical Trial Monitoring
By Laura Brown
FDA 510(k) Update: Recent Trends and Good Practices Compliant with eCopy and RTA policy
By David Lim
10 Steps to Perfect SOPs: FDA Acceptable SOPs made Easy
By Mukesh Kumar
Quality Management Systems for Medical Devices and IVDs
By David Lim
Technical Writing Best Practices
By Robert Peoples
Human Factors Usability Studies Following ISO 62366 and FDA Guidance
By Edwin Waldbusser
Data Governance for Computer Systems Regulated by FDA
By Carolyn Troiano
Effective and Practical use of FMEA For Risk-Based Approach to Computer Systems Validation
By Joy McElroy
FDA vs EU Inspections – Getting Prepared and What are Differences
By Marie Dorat
Critical SOPs for Clinical Sites
By Mukesh Kumar
Managing Foreign Inspections - Before, During and After
By Casper E Uldriks
10 Steps to Perfect SOPs: FDA Compliance made easy
By Mukesh Kumar
The Infamous Form FDA 483: How you respond can make or break you
By Casper E Uldriks
Container – Closure Systems for Lyophilized Products
By Jeff Schwegman
Requirements for Medical Device Developers to Meet the U.S. FDA's Requirements on the 510(k)
By David Lim
FDA - Streamlining Your Internal Auditing Process
By Betty Lane
In Depth Testing of Computer Systems Regulated by FDA
By Carolyn Troiano
Putting together a Q-Submission and 510(k): Best Practices
By David Lim
How to Develop Quality Systems for New Diagnostic Assays
By Todd Graham
New Rules for Compounding Pharmacies: Best Practices for Compliance
By Mukesh Kumar
Practical Strategies to a successful 505(b)(2) product
By Mukesh Kumar
Computerized System Validation: Basic Concepts
By Angela Bazigos
FDA Part 820 Basics - Everything you Need to Know to Get your Start-up Company Compliant
By Denise Wrestler
510(k): Submission and Clearance
By David Lim
510(k): Format, Contents and Case Studies
By David Lim
Qualification of Contract Manufacturer Organizations Based on Practical Experience
By Edwin Waldbusser
FDA Compliant QC and QA Practices: Creating a Perfect, Audit-Ready QMS
By Joy McElroy
How FDA Inspection Observations are Reviewed for Regulatory Action
By Luis Chavarria
FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List
By David R Dills
Part 11 Compliance Simplified: Easy, Cheap and Fast Steps to Meet FDA Requirements
By Mukesh Kumar
Technical Writer Training
By Robert Peoples
Auditing for Microbiological Aspect of Pharmaceutical and Biopharmaceutical Manufacturing
By Carl Patterson
Discussion Regarding the Substitution of a New Inactive Ingredient in an Approved Parenteral Drug Product
By Lamont M. Fulton
510(k): How To Navigate Through Hurdles And Get It Cleared
By David Lim
Systems Validation Made Easy
By Herman Wong
EU GDPR Deadline is Just around the Corner: Understanding Compliance for Clinical Trials for Life Sciences Companies
By Laura Brown
Managing the FDA form "483": Inspection Observations
By Casper E Uldriks
IEC 62304: Medical Device Software Development and Validation
By Chinmoy Roy
Strategies to Capture, Preserve and Authenticate R&D Information for Patent Protection and Litigation
By Charlie Sodano
Global Best Practices for Cleaning and Disinfection of Cleanrooms and Disinfection Validation
By Tim Sandle
System Suitability Testing in the Pharmaceutical Laboratory: Addressing FDA and USP Compliance
By Gregory Martin
Load More Record Webinar