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Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
13-14 Sept 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
$2,995
Cybersecurity - US FDA Requirements – New Course !
14 Sep This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production
John E Lincoln John E Lincoln
$240
3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)
On 16 Sep 2021 This webinar will review the regulatory requirements for investigating an OOS Investigation.
Danielle DeLucy Danielle DeLucy
$399
Post Market Surveillance - Complaint Handling and Medical Device Reporting
16 Sep This webinar will cover the basics of complaint management and medical device reporting
Susanne Manz Susanne Manz
$229
FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You
On 16 - 17 Sep, 2021 this training will Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S. Pharmaceutical and Biotech.
Karl M. Nobert Karl M. Nobert
$1,899
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
Sep 20-21, 2021 The seminar will provide attendees with a better understanding of responsibilities and gain a greater knowledge of the issues faced
David R. Dills David R. Dills
$1,299
Full Day Virtual Workshop Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Syst
On 21 September 2021 This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated
Joy L. McElroy Joy L. McElroy
$695
Preventing Human Error in the Life Sciences Virtual Seminar (4 hours)
21 Sep This four hour virtual seminar, will explore the true causes and nature of human error, how human error should be investigated
Charles H. Paul Charles H. Paul
$599
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
Sep 23 - 24 The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar is to explore raw materials and their requirements – issues and solutions.
Barry A. Friedman Barry A. Friedman
$1,699
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
Sep 23 - 24 The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar is to explore raw materials and their requirements – issues and solutions.
Barry A. Friedman Barry A. Friedman
€1.895
Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment
29 Sep This live training will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase
Barry A. Friedman Barry A. Friedman
$299
FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar
Oct 04-06 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
$1,950
Technical Writing for professionals in the life sciences
Oct 05 -07 This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents
Charles H. Paul Charles H. Paul
$1,495
Write it Right – Standard Operating Procedures
On 05 October 2021 this webinar will help you to write complete, clear, unambiguous, and flexible SOPs.
Susanne Manz Susanne Manz
$487
Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies
05 Oct This webinar will provide a step by step approach and valuable tips for setting up a Quality System to withstand FDA Audits
Meena Chettiar Meena Chettiar
$199
The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam
06 Oct This webinar will examine a variety of issues surrounding water in a facility to include the testing of each water source.
Barry A. Friedman Barry A. Friedman
$199
CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture
07 Oct This Webinar presentation will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective.
Roger Cowan Roger Cowan
$299
Biostatistics for the Non-Statistician
Oct 18-20, 2021 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
€4.665
Biostatistics for the Non-Statistician
Oct 18-20, 2021 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
$4,665
What You Need to Know: Auditing EU-MDR and EU-IVDR Implementation
12 Oct In this webinar you will learn about Auditing EU-MDR and EU-IVDR Implementation. We’ll share insights on the importance of good project management method
David R. Dills David R. Dills
$399
Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices
Oct 14-15 , 2021 This 2-day virtual seminar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe
Susanne Manz Susanne Manz
$1,295
How FDA trains its investigators to review CAPA and what should you do to prepare
14 Oct 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
$299
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
19 Oct Download This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted
David Nettleton David Nettleton
$199
Calculations for Process and Product Capability
21 Oct This Webinar will focus on providing the information needed for attendees to know the appropriate measures and formulas
Elaine Eisenbeisz Elaine Eisenbeisz
$249
Production and Process Controls for Medical Devices What You Need to Know
21 Oct This webinar can help you prevent serious issues such as these. You’ll learn about FDA quality system regulation expectations, and how you can
Susanne Manz Susanne Manz
$487
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
Oct 21-22 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
$1,495
6 Hours Annual Online Human Error Certification Training Program
25 Oct this training would provide tools that can be implemented and used after this event.
Ginette Collazo Ginette Collazo
$499
Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention
26 Oct This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing a complaint-
Jeff Kasoff Jeff Kasoff
$199
A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19— Complaint Handling, MDR Reporting and Recalls
Oct 21 - 22 this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.
Rita Hoffman Rita Hoffman
$1,498
A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19— Complaint Handling, MDR Reporting and Recalls
On 21-22-Oct, 2021 this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.
Rita Hoffman Rita Hoffman
€1.295
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Oct 21 - 22 The lifecycle concept, new to these Guidances, link product and process development, qualification of the commerc
Barry A. Friedman Barry A. Friedman
$1,495
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Oct 26 - 27 The lifecycle concept, new to these Guidances, link product and process development, qualification of the commerc
Barry A. Friedman Barry A. Friedman
€1.295
FDA Regulatory Compliance for Drug and Biotech Product
Oct 28-29 ,2021 at 11:00 AM - 05:00 PM EDT
Karl M. Nobert Karl M. Nobert
$6,000
Good Documentation Practices
MP3 Download 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
Learn the Latest FDA Compliance and Mobile Applications Live Webinar
02 Nov This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze, transfer
Carolyn Troiano Carolyn Troiano
$199
Good Clinical Practice (GCP) Refresher Training
03 Nov This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements
John E Lincoln John E Lincoln
$399