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6 Hours Annual Online Human Error Certification Training Program
On 17 June this training would provide tools that can be implemented and used after this event.
Ginette Collazo Ginette Collazo
$499
FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar
June 21-23 This Course will explain how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
Carolyn Troiano Carolyn Troiano
$1,295
Computer System Validation Professional Certification Program 3 Days
June 21-23 this course will completely immerse you in computer system validation and delivers comprehension of the regulations impacting your system
Carolyn Troiano Carolyn Troiano
€1.295
Computer System Validation Professional Certification Program 3 Days
This 3 day CSV course will teach you how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
Carolyn Troiano Carolyn Troiano
$1,295
2 Day Virtual Seminar on FDA Inspection Essentials in 2021
On 15-16 June This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol
Danielle DeLucy Danielle DeLucy
€1.295
2 Day Virtual Seminar on FDA Inspection Essentials in 2021
On 15-16 June This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol
Danielle DeLucy Danielle DeLucy
$1,295
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
28-29 June Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit inspection, overview of the European Medicines Agency's Guid
Michael Ramcharan Michael Ramcharan
$1,695
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
August 12-13 This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend
Kelly Thomas Kelly Thomas
€1.295
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
June 15-16 This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend
Kelly Thomas Kelly Thomas
$1,599
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
Aug 12-13 This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend
Kelly Thomas Kelly Thomas
$1,498
The Veterinary Drug Approval Process and FDA Regulatory Oversight
Aug 26-27 This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government
Karl M. Nobert Karl M. Nobert
$4,995
The Veterinary Drug Approval Process and FDA Regulatory Oversight
August 26-27 This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government
Karl M. Nobert Karl M. Nobert
€1.295
Cybersecurity - US FDA Requirements – New Course !
21 June This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production by the CAPA s
John E Lincoln John E Lincoln
$240
QA and Risk Management approaches when Managing Clinical Trial Data – New Course !
24 June This presentation focuses on the role of QA in the Risk Management process when deciding on how data should be collected
Carolyn Troiano Carolyn Troiano
$229
Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course
25 June This training course will provide a practical understanding of the requirement for a data governance framework
Carolyn Troiano Carolyn Troiano
$695
Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience
29 June This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs)
Edwin Waldbusser Edwin Waldbusser
$229
3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC
29 June This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software Life-cycle a
Jose Mora Jose Mora
$399
Production and Process Controls for Medical Devices What You Need to Know
30 June This webinar can help you prevent serious issues such as these. You’ll learn about FDA quality system regulation expectations, and how you can successfu
Susanne Manz Susanne Manz
$287
Medical Device Cybersecurity and FDA Compliance
06 July This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products
Carolyn Troiano Carolyn Troiano
$695
Root Cause Analysis Techniques and CAPA Management
7 July This webinar will give you a systematic approach that utilizes quality tools to objectively identify factors that have resulted in or could contribute to
Kelly Thomas Kelly Thomas
$299
Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements
07 July This webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s)
John E Lincoln John E Lincoln
$199
Excel Spreadsheet Validation-Step-by-step guide to data integrity compliance in the COVID-19 Era
08 July This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$249
FDA’s Plan to Modernize the 510(k) Pathway: What Regulatory, Quality and Compliance Professionals Need to Know
12 July This webinar will discuss the 510(k) framework to reflect advances in device technology, safety and capabilities, making it harder to obtain clearance.
John E Lincoln John E Lincoln
$287
Power Analysis for Sample Size Calculations
13 July In this webinar speaker will explain how to put the power analysis techniques to use will help to assure that you’ll collect a large enough sample to se
Elaine Eisenbeisz Elaine Eisenbeisz
$249
The Drug Development Process from Concept to Market
July 13-14 The course starts by considering the global pharmaceutical market, important therapeutic areas and the roles of different pharmaceutical professional
Karl M. Nobert Karl M. Nobert
$3,995
How FDA trains its investigators to review CAPA and what should you do to prepare
13 July This webinar will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar
Jeff Kasoff Jeff Kasoff
$199
Good Documentation Practices
14 July This presentation will discuss the purpose of good documentation, what proper documentation looks like and a brief discussion of elements
David W. Husman David W. Husman
$199
Biostatistics for the Non-Statistician
On 14-16 July this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
$1,695
Management Review to ensure a Suitable and Effective Quality Management System
15 July In this course, we’ll discuss how to improve awareness, focus, and a culture of quality
Susanne Manz Susanne Manz
$199
Understanding Medical Device Design Controls What, Why, and How
On 19 July this FDA Design Control course online is US-focused. The participants will gain a fundamental understanding of how medical devices are regulated.
Alan Golden Alan Golden
$599
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
20 July Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820
John E Lincoln John E Lincoln
$229
2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
July 21-22 This 2 day seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your organization
Kelly Eisenhardt Kelly Eisenhardt
$1,695
FDA Regulation of Artificial Intelligence/ Machine Learning
21 July This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML
Edwin Waldbusser Edwin Waldbusser
$265
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
21 July This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program
Frank Stein Frank Stein
$429
Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs
22 July This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle
Carolyn Troiano Carolyn Troiano
$392
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products
August 5-6 This course is designed to provide participants with an up-to-date understanding of the drug and biotech requirements for FDA regulatory compliance
Karl M. Nobert Karl M. Nobert
€1.595