Pharmaceuticals - Eventura

AI for CAPA and Investigations: Where It Helps and Where It Can Get You in Trouble

Duration: 60 Minutes Access Format: Instant Streaming via TalkFDA Validity: 30 Days Unlimited viewing Includes: Handout, Assessment, and Certification on TalkFDA

CHARLES H. PAUL

Clinical Trial Risk Management - ICH E6(R3) and FDA Expectations

Duration: 60 Minutes

CHARLES H. PAUL

Dissolution Testing in Pharma - From Development to Regulatory Approval

Duration: 60 Minutes

SCOTT R. THATCHER

ChatGPT and AI-Powered Project Management - Revolutionize your Projects Now

Duration: 60 Minutes

CHARLES H. PAUL

Corrective Actions Preventive Actions - CAPA 101

Duration: 60 Minutes

Sampling Plans for Verification, Validation and Production

Duration: 90 Minutes

The Transfer Of Validated Methods

Duration: 60 Minutes

Dr. JOHN C. FETZER

Analytical Method Validation under Good Laboratory Practices (GLPs)

Duration: 90 Minutes

Dr. JOHN C. FETZER

eCTD Submissions - Fundamentals and Process

Duration: 90 Minutes

CHARLES H. PAUL

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

Duration: 90 Minutes

Calculations for Process and Product Capability

Duration: 90 Minutes

ELAINE EISENBEISZ

Nitrosamines Impurities Management

Duration: 2 Hour

Statistical Methods For Process Validation

Duration: 60 Minutes

Business Continuity Planning For Contract Manufacturers In The Life Sciences

Duration: 90 Minutes

CHARLES H. PAUL

Compliance Audit Enhancement Using Principles Of Lean Documents And Lean Configuration

Duration: 90 Minutes

HPLC Analytical Method Development And Validation

Duration: 60 Minutes

Dr. JOHN C. FETZER

Risk Assessment Demystified And Digital Advancements

Duration: 60 Minutes

Latest Regulations For Quality Metrics And KPIS

Duration: 90 Minutes

MEREDITH CRABTREE

OOS And Setting Specifications For Pharma, Biopharma And Combination Products

Duration: 90 Minutes

Practical Implementation Of Pharmaceutical Quality Risk Management (QRM)

Duration: 60 Minutes

GCP Risk Management And Risk-Based Monitoring

Duration: 90 Minutes

CHARLES H. PAUL

Setting Up Scientifically Sound Laboratory Controls - Specifications And Test Procedures

Duration: 90 Minutes

Project Management For Non-Project Managers Series - Project Management As Applied To Clinical Trials

Duration: 90 Minutes

CHARLES H. PAUL

Project Management For Non-Project Managers Series - Project Management Process In Development Of In Vitro Diagnostics

Duration: 90 Minutes

CHARLES H. PAUL

Project Management for Non-Project Managers - Project Management in Drug Development

Duration: 90 Minutes

CHARLES H. PAUL

Sampling Plans For Verification And Validation, Production Process Validation And Production Control

Duration: 90 Minutes

Process Verification And Validation - Principles And Protocols

Duration: 90 Minutes

JOHN E. LINCOLN

Project Management For Non-Project Managers - Getting The Project Off The Ground - Preliminary Project Planning

Duration: 2 Hour

CHARLES H. PAUL

Hypothesis Testing, P-Values, And Inference – When Thinking Like a Statistician Makes Sense

Duration: 90 Minutes

ELAINE EISENBEISZ

3-Hour Virtual Seminar On Batch Record Review And Product Release

Duration: 3 Hour

DANIELLE DELUCY

Continued Process Verification And Process Monitoring

Duration: 90 Minutes

Step-By-Step Process For Successful Sterility Failure Investigations

Duration: 60 Minutes

DANIELLE DELUCY

Human Error Investigation Program - Effective Implementation

Duration: 90 Minutes

Dr. Ginette Collazo

Photostability ICH Q1B: Practical Interpretation and Execution

Duration: 60 Minutes

SCOTT R. THATCHER

RISK MANAGEMENT AND IMPACT ASSESSMENTS IN CHANGE CONTROL

Duration: 60 Minutes

DESIGN CONTROL 2023: PROJECT MANAGEMENT UTILIZING PRINCIPLES OF LEAN DOCUMENTS AND LEAN CONFIGURATION

Duration: 90 Minutes

ESTABLISHING AND REGAINING CONTROL OF CLEANROOM

Duration: 90 Minutes

Good Documentation Practices

Duration: 75 Minutes

DANIELLE DELUCY

Impact Assessments for Supplier Change Notices

Duration: 60 Minutes

FDA EXPECTATIONS FOR 505(B)(2) REGULATORY PATHWAY FOR NEW DRUGS

Duration: 90 Minutes

QUALIFICATION AND CONTROL OF CONTRACT MANUFACTURER ORGANIZATIONS BASED ON PRACTICAL EXPERIENCE

Duration: 60 Minutes

Edwin Waldbusser

NAVIGATING THE FDA'S GUIDELINES ON OFF-LABEL PROMOTIONS

Duration: 90 Minutes

CHANGE CONTROL ACCORDING TO GXP AND GMP REQUIREMENTS

Duration: 4 Hour

Handling Out-of-Trend Results in Pharmaceutical Quality Control as per Latest FDA Requirements

Duration: 90 Minutes

FDA Case Scenarios – Best Practices for Managing Inspection Situations

Duration: 75 Minutes

DANIELLE DELUCY

POWER ANALYSIS FOR SAMPLE SIZE CALCULATIONS

Duration: 90 Minutes

ELAINE EISENBEISZ

IMPLEMENTING AN EFFECTIVE GLP COMPLIANT QUALITY MANAGEMENT SYSTEM

Duration: 90 Minutes

Dr. JOHN C. FETZER

3 Hours Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

Duration: 3 Hour

CAROLYN TROIANO