Pharmaceuticals - Eventura

Corrective Actions Preventive Actions - CAPA 101

Duration: 60 Minutes

Sampling Plans for Verification, Validation and Production

Duration: 90 Minutes

The Transfer Of Validated Methods

Dr. JOHN C. FETZER

Duration: 60 Minutes

eCTD Submissions - Fundamentals and Process

CHARLES H. PAUL

Duration: 90 Minutes

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

Duration: 90 Minutes

Calculations for Process and Product Capability

ELAINE EISENBEISZ

Duration: 90 Minutes

Nitrosamines Impurities Management

Duration: 2 Hour

Statistical Methods For Process Validation

Duration: 60 Minutes

Business Continuity Planning For Contract Manufacturers In The Life Sciences

CHARLES H. PAUL

Duration: 90 Minutes

Compliance Audit Enhancement Using Principles Of Lean Documents And Lean Configuration

Duration: 90 Minutes

HPLC Analytical Method Development And Validation

Dr. JOHN C. FETZER

Duration: 60 Minutes

Risk Assessment Demystified And Digital Advancements

Duration: 60 Minutes

Latest Regulations For Quality Metrics And KPIS

MEREDITH CRABTREE

Duration: 90 Minutes

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

CHARLES H. PAUL

Duration: 90 Minutes

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

CHARLES H. PAUL

Duration: 90 Minutes

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

CHARLES H. PAUL

Duration: 90 Minutes

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

CHARLES H. PAUL

Duration: 90 Minutes

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

Duration: 90 Minutes

Process Verification And Validation - Principles And Protocols

JOHN E. LINCOLN

Duration: 90 Minutes

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

CHARLES H. PAUL

Duration: 2 Hour

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

ELAINE EISENBEISZ

Duration: 90 Minutes

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

DANIELLE DELUCY

Duration: 3 Hour

Continued Process Verification And Process Monitoring

Duration: 90 Minutes

Step-By-Step Process For Successful Sterility Failure Investigations

DANIELLE DELUCY

Duration: 75 Minutes

Human Error Investigation Program - Effective Implementation

Dr. Ginette Collazo

Duration: 90 Minutes

Photostability ICH Q1B: Practical Interpretation and Execution

SCOTT R. THATCHER

Duration: 60 Minutes

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

DANIELLE DELUCY

Duration: 75 Minutes

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

Edwin Waldbusser

Duration: 60 Minutes

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

DANIELLE DELUCY

Duration: 75 Minutes

POWER ANALYSIS FOR SAMPLE SIZE CALCULATIONS

ELAINE EISENBEISZ

Duration: 90 Minutes

IMPLEMENTING AN EFFECTIVE GLP COMPLIANT QUALITY MANAGEMENT SYSTEM

Dr. JOHN C. FETZER

Duration: 90 Minutes

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

CAROLYN TROIANO

Duration: 3 Hour

3-Hour Virtual Seminar on Technical Writing for the Regulated Industries

Duration: 3 Hours

Statistical Process Control (SPC) and Control Charts for Laboratory Compliance

Dr. JOHN C. FETZER

Duration: 60 Minutes

Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations

CAROLYN TROIANO

Duration: 90 Minutes

Writing Followable Procedures – Avoid Procedure Related Deviations

Dr. Ginette Collazo

Duration: 90 Minutes

Data Integrity by Design, Pharma 4.0 and Overcoming DI issues in the Cloud

CAROLYN TROIANO

Duration: 75 Minutes