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Medical Device
Medical Device
Add To Cart
Recording
Risk-Based Excel Spreadsheet Validation
FDB3644
CAROLYN TROIANO
Duration: 90 Minutes
Add To Cart
Recording
FDA Regulation For Over-The-Counter (OTC) Drug Products
FDB3614
MEREDITH CRABTREE
Duration: 90 Minutes
Add To Cart
Recording
3-Hour Virtual Seminar On U.S. FDA And EU Medical Device Directive Requirements For DHFS, DMRS, DHRS, And TF/DDS
MD3385
JOHN E. LINCOLN
Duration: 3 Hour
Add To Cart
Recording
Preventive Maintenance And Calibrations - Regulatory Expectations And Best Practices
FDB3613
MEREDITH CRABTREE
Duration: 90 Minutes
Add To Cart
Recording
Using Audit Trails To Support Part 11 Data Integrity Compliance
FDB3643
CAROLYN TROIANO
Duration: 90 Minutes
Add To Cart
Recording
The US FDA QMSR Transition - 21 CFR 820 And ISO 13485
MD3650
JOHN E. LINCOLN
Duration: 90 Minutes
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Recording
Design Control For Medical Devices And Combination Products
MD3594
Alan M. Golden
Duration: 60 Minutes
Add To Cart
Recording
Clinical Trial Master File (TMF) And Electronic Trial Master File (ETMF)
FDB3641
CAROLYN TROIANO
Duration: 90 Minutes
Add To Cart
Recording
Drug Master Files (DMFS) - Understanding And Meeting Your Global Regulatory And Processing Responsibilities
FDB3663
CHARLES H. PAUL
Duration: 90 Minutes
Add To Cart
Recording
The FDA Inspection From SOP To 483
FDB1888
JOSÉ MORA
Duration: 90 Minutes
Add To Cart
Recording
IQ, OQ And PQ Quality Protocols - Current Regulatory Requirements
FDB3414
KELLY THOMAS
Duration: 90 Minutes
Add To Cart
Recording
EU's New Regulation 536/2014 On Clinical Trials - Insights Into Effective Clinical Trials
FDB3555
JOHN E. LINCOLN
Duration: 90 Minutes
Add To Cart
Recording
Production And Process Controls For Medical Devices
MD2028
SUSANNE MANZ
Duration: 90 Minutes
Add To Cart
Recording
Establishing FDA-Compliant Product Stability Testing Program
FDB3099
KELLY THOMAS
Duration: 60 Minutes
Add To Cart
Recording
Moving From CSV To CSA
FDB3513
Saurabh Joshi
Duration: 60 Minutes
Add To Cart
Recording
3-Hour Virtual Seminar On US FDA Cybersecurity Requirements - The Latest Developments
MD3558
JOHN E. LINCOLN
Duration: 3 Hour
Add To Cart
Recording
Data Integrity And Human Error
FDB3072
Dr. Ginette Collazo
Duration: 90 Minutes
Add To Cart
Recording
FDA vs EU Inspections - Differences And Similarities - How To Get Prepared
FDB3661
CHARLES H. PAUL
Duration: 90 Minutes
Add To Cart
Recording
Risk Management For ML Medical Devices Following AAMI/ BSI TR 34971 And ISO 14971
MD3298
Edwin Waldbusser
Duration: 60 Minutes
Add To Cart
Recording
3-Hour Virtual Seminar On Root Cause Analysis, CAPA And Effectiveness Checks
FDB3611
MEREDITH CRABTREE
Duration: 3 Hour
Add To Cart
Recording
FDA/ICH Guideline Q9 (R1) On Quality Risk Management
FDB3610
MEREDITH CRABTREE
Duration: 90 Minutes
Add To Cart
Recording
Good Clinical Practices Review of ICH E6 (R3) Latest Guidance
FDB3660
CHARLES H. PAUL
Duration: 60 Minutes
Add To Cart
Recording
Innovative Strategies - Harnessing Design Controls For QMS Excellence
MD1886
José Mora
Duration: 90 Minutes
Add To Cart
Recording
Medical Device Cybersecurity Following Latest FDA Guidance
MD3391
Edwin Waldbusser
Duration: 60 Minutes
Add To Cart
Recording
Auditing Laboratory Data Systems
FDB3097
KELLY THOMAS
Duration: 90 Minutes
Add To Cart
Recording
HANDLING MEDICAL DEVICE COMPLAINTS & CAPA
MD3398
Edwin Waldbusser
Duration: 60 Minutes
Add To Cart
Recording
3-HOUR VIRTUAL SEMINAR ON ANALYTICAL METHOD VALIDATION AND TRANSFER
FDB3095
KELLY THOMAS
Duration: 3 Hour
Add To Cart
Recording
FDA’S RECENT REGULATION ON THE USE OF SOCIAL MEDIA
FDB3140
CAROLYN TROIANO
Duration: 90 Minutes
Add To Cart
Recording
3-Hour Virtual Seminar on Part 11 Data Integrity and Cybersecurity – The Latest Developments
MD3552
JOHN E. LINCOLN
Duration: 3 Hour
Add To Cart
Recording
3-HOUR VIRTUAL SEMINAR ON IQ, OQ, PQ IN THE VERIFICATION AND VALIDATION PROCESS
MD3589
SUSANNE MANZ
Duration: 3 Hour
Add To Cart
Recording
EQUIPMENT QUALIFICATION AND PROCESS VALIDATION
FDB3510
Saurabh Joshi
Duration: 60 Minutes
Add To Cart
Recording
UNDERSTANDING AND IMPLEMENTING A QUALITY BY DESIGN (QBD) PROGRAM
FDB2309
Steven Laurenz
Duration: 60 Minutes
Add To Cart
Recording
HOW TO DEPLOY ROOT CAUSE AND CAPA TO MINIMIZE HUMAN ERROR
FDB3217
Dr. Ginette Collazo
Duration: 90 Minutes
Add To Cart
Recording
A RISK BASED APPROACH TO IT INFRASTRUCTURE QUALIFICATION, COMPLIANCE & CONTROL
FDB3548
CAROLYN TROIANO
Duration: 3 Hour
Add To Cart
Recording
FDA VS HEALTH CANADA - SIMILARITIES AND DIFFERENCES BETWEEN THE TWO REGULATORY BODIES
FDB3572
JOY MCELROY
Duration: 90 Minutes
Add To Cart
Recording
US FDA DRUG REVIEW AND APPROVAL PROCESS
FDB3571
JOY MCELROY
Duration: 60 Minutes
Add To Cart
Recording
3-HOUR VIRTUAL SEMINAR ON 510(K)'S, PMA'S, IDE'S AND DENOVO'S
MD3554
JOHN E. LINCOLN
Duration: 3 Hour
Add To Cart
Recording
Auditing Computer Systems for Part 11 and International Compliance
FDB3546
CAROLYN TROIANO
Duration: 90 Minutes
Add To Cart
Recording
MEDICAL DEVICE HAZARD ANALYSIS FOLLOWING ISO 14971
MD3419
Edwin Waldbusser
Duration: 90 Minutes
Add To Cart
Recording
Validation Sampling Plans and Setting Acceptance Criteria
FDB3590
Alan M. Golden
Duration: 60 Minutes
Add To Cart
Recording
Quality in Technology Transfer Projects
FDB3511
Saurabh Joshi
Duration: 60 Minutes
Add To Cart
Recording
MDSAP Audits – All You Need to Know
MD2295
MEENA CHETTIAR
Duration: 75 Minutes
Add To Cart
Recording
How to get a 510(k) for a Machine Learning Product
MD3294
Edwin Waldbusser
Duration: 60 Minutes
Add To Cart
Recording
3-Hour Virtual Seminar on GAMP® 5 Second Edition – The changes and its impacts that you should know
FDB3545
CAROLYN TROIANO
Duration: 3 Hours
Add To Cart
Recording
How FDA trains its Investigators to Review CAPA and How should you prepare
FDB3561
CHARLES H. PAUL
Duration: 60 Minutes
Add To Cart
Recording
Effective Design Control (21 CFR Part 820.30)
MD1988
JOHN E. LINCOLN
Duration: 90 Minutes
Add To Cart
Recording
FDA REGULATION OF ARTIFICIAL INTELLIGENCE / MACHINE LEARNING
FDB3397
Edwin Waldbusser
Duration: 60 Minutes
Add To Cart
Recording
Step-by-Step approach for Setting up FDA Audit Ready Quality Management System (QMS) – Case Studies based training
FDB3563
MEENA CHETTIAR
Duration: 90 Minutes
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