Pharmaceuticals - Eventura

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

How to go Paperless in an FDA-Regulated Environment using Electronic Workflow Signature Approvals and Electronic Records

CAROLYN TROIANO

Duration: 75 Minutes

4-Hour Virtual Seminar on Project Management for Non-Project Managers

CHARLES H. PAUL

Duration: 4 Hours

Writing Validation Master Plans – Best Practices for Writing a Compliant Document

Duration: 90 Minutes

3-Hour Certification Course on Good Manufacturing Practices (GMP) – An Introduction

MICHAEL ESPOSITO

Duration: 3 Hours

Clinical Quality Auditing

PAM DELLEA-GILTNER

Duration: 90 Minutes

Good Clinical Practices (GCP) Compliance – Audit Preparation and Inspection Readiness

MARINA MALIKOVA

Duration: 60 Minutes

Excel Spreadsheet Validation In GxP Environment

HitendraKumar Shah

Duration: 120 Minutes

How to conduct Annual Product Reviews to achieve GMP Compliance

DANIELLE DELUCY

Duration: 75 Minutes

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Duration: 90 Minutes

Regulatory Issues in Pharmacogenomics

Duration: 90 Minutes

Adherence to the principles of good clinical practices

Duration: 90 Minutes

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

Duration: 90 Minutes

FDA’s 21 CFR Part 11 Add-on Inspections

Duration: 90 Minutes

Drug Development & Discovery by FDA Standards

Duration: 90 Minutes

21 CFR 11 Compliance for Excel Spreadsheets

Duration: 90 Minutes

Project Management for Computer Systems Validation

Duration: 90 Minutes

Sterile Filtration of Pharmaceutical Products – Validation and Regulatory Requirements

Duration: 60 Minutes

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Duration: 60 Minutes

CMO Supplier Quality Agreements – How to Comply with New FDA and EU Guidelines for Contract Drug Manufacture

Duration: 60 Minutes

Pharmaceutical Compressed Air – Quality GMP Standards and Requirements

Duration: 60 Minutes

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Duration: 60 Minutes

FDA Quality Metrics and Risk Based Inspections

ANGELA K. DUNSTON

Duration: 90 Minutes