KELLY THOMAS - Eventura

The New EU Medical Devices Regulations Training - Essential Tasks to Complete the EU MDR Implementation and Transition

2-Day Seminar Recording

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

Duration: 90 Minutes

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

Duration: 90 Minutes

CHANGE CONTROL ACCORDING TO GXP AND GMP REQUIREMENTS

Duration: 4 Hour

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

Duration: 90 Minutes

NAVIGATING THE FDA'S GUIDELINES ON OFF-LABEL PROMOTIONS

Duration: 90 Minutes

3-HOUR VIRTUAL SEMINAR ON ANALYTICAL METHOD VALIDATION AND TRANSFER

Duration: 3 Hour

Aseptic Process Overview and Validation

Duration: 90 Minutes

How to Write Effective 483 and Warning Letter Responses

Duration: 90 Minutes

Analytical Method Validation and Transfer

Duration: 90 Minutes

Risk-Based Environmental Monitoring Program

Duration: 90 Minutes

3-Hour Virtual Seminar on Establishing a Robust Data Integrity Program

Duration: 3 Hour

How to Perform a Thorough Root Cause Analysis and CAPA Development

Duration: 90 Minutes

Effective Supplier Management Programs

Duration: 90 Minutes

Auditing Laboratory Data Systems

Duration: 90 Minutes

Continued Process Verification And Process Monitoring

Duration: 90 Minutes

Establishing FDA-Compliant Product Stability Testing Program

Duration: 60 Minutes

IQ, OQ And PQ Quality Protocols - Current Regulatory Requirements

Duration: 90 Minutes

OOS And Setting Specifications For Pharma, Biopharma And Combination Products

Duration: 90 Minutes

Designing Effective And Efficient Extractables Or Leachables Studies

Duration: 90 Minutes

Supplier And Contract Manufacturer Management

October 24 - 25, 2024 | US Eastern Time: 10 AM to 3 PM | Central Europe Time: 4 PM to 9 PM

Analytical Instrument Qualification and Excel Validation - Preparing for FDA Audits

September 11 - 12, 2024 | US Eastern Time: 9 AM to 2 PM | Central Europe Time: 3 PM to 8 PM

Quality Control Laboratory Compliance - cGMP and GLP Training

2-Day Seminar Completed | Recording and Pre-Registration Available

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

Duration: 90 Minutes

OOS and OOT Investigations Course - Best Practices, Key Components and a Comprehensive Review of the FDA Requirements

September 26 - 27, 2024 | US Eastern Time: 10 AM to 3 PM | Central Europe Time: 4 PM to 9 PM

Aseptic Processing and Validation Course

2-Day Seminar Completed | Recording and Pre-Registration Available