WCS

Medical Device Directive (MDD) to Medical Device Regulation (MDR) Transition Training Course Online

06-28 Apr Virtual Training Online on EU-MDR to align your company with the new requirements of the Medical Device Regulation (EU-MDR) by UK top Industry Expert

Frank Stein

€1.695

Medical Device Directive (MDD) to Medical Device Regulation (MDR) Transition Training Course Online

06-28 Apr Virtual Training Online on EU-MDR to align your company with the new requirements of the Medical Device Regulation (EU-MDR) by UK top Industry Expert

Frank Stein

$1,495

FDA’s Plan for Modernizing the 510(k) Pathway

20 April This FDA Training online will explain Basic of US FDA’s Expectations for the 510(k), The Medical Device Safety Action Plan and 510(k)

John E Lincoln

$179

Vaccine Patents in the Current Pandemic Climate Live Webinar

21 Apr This presentation will discuss not only the global patenting issues facing vaccines but will also look at some of the challenges facing vaccine patenting

Joanna Brougher

$199

Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense

22 April You will learn the why and how of the scientific method, and how to view the world with a statistician’s eyes

Elaine Eisenbeisz

$1,025

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training

April 20-21-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

$1,295

The Veterinary Drug Approval Process and FDA Regulatory Oversight

April 22-23 -This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government approval.

Karl M. Nobert

$1,899

Knock, knock, who’s there? Are you ready for an FDA inspection in the COVID-19 Era and Beyond?

27 April This webinar will help you manage inspections efficiently and effectively. You’ll learn about the FDA’s inspectional approach, focus areas and prepare

Susanne Manz

$389

Computer System Validation Professional Certification Program 3 Days

April 27-29

Carolyn Troiano

$1,495

FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar

On April 27-29 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

$1,495

How FDA trains its investigators to review CAPA and what should you do to prepare

28 Apr 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 with.

Jeff Kasoff

$199

Biostatistics for the Non-Statistician

28-30 April this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

Elaine Eisenbeisz

$1,595

The European PSMF

29 Apr This course teaches you with evolution of the PSMF and the legislation concerning it for the EU, sections of the PSMF, annexes of the PSMF and Audits

Charity Ogunsanya

$199

Data Integrity and Data Governance for Computer Systems Regulated by FDA

29 Apr This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation

Carolyn Troiano

$299

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

29 Apr This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration

Roger Cowan

$299

Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage

6 May This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need

Jeff Kasoff

$199

Understanding Medical Device Design Controls What, Why, and How

On 06 May this FDA Design Control course online is US-focused. The participants will gain a fundamental understanding of how medical devices are regulated.

Alan Golden

$599

FDA Recalls - Before You Start, and After You Finish

On 11 - 12 May, 2021 this seminar will help you to Understand FDA's recall authority and policy , Learn how to manage recalls under FDA oversight.

Kelly Thomas

$1,599

Is My Data Abnormal? Normality Tests and Transformations Live Webinar

12 May In this webinar, you will also learn tools and concepts to understand what makes a distribution normal and when a transformation of data

Elaine Eisenbeisz

$299

Purchasing Controls, Receiving Inspection, and Supplier Audit – what to do during a global pandemic

13 May . This webinar will provide insights into how to use remote auditing techniques to minimize the risk and maximize the benefits of conducting audits

Susanne Manz

$199

FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You

On 13 - 14-May, 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

$1,699

A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19— Complaint Handling, MDR Reporting and Recalls

On 18-19-May, 2021 this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.

Kelly Thomas

$1,599

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

On 19-21 May Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit inspection, overview of the European Medicines Agency's Guid

Cynthia Brysch

$1,695

The Healthcare Quality Improvement Act: Achieving Immunity in Your Peer Review Process

19 May This webinar will discuss the Health Care Quality Improvement Act (HCQIA) in detail, including the standards that must be met to achieve immunity under t

William Mack Copeland

$199

Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment

19 May 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

$299

Excel Spreadsheet Validation-Step-by-step guide to data integrity compliance in the COVID-19 Era

19 May This session will make you a better Excel user, saving you time and costs

David Nettleton

$249

21 CFR Part 11, SaaS/Cloud, EU GDPR - What Regulatory, Quality & Compliance Professionals Need to Know

01 June 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

$249

2 Day Virtual Seminar on FDA Inspection Essentials in 2021

On 01-02 June This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol

Danielle DeLucy

$1,599

Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

02 June This session will benefit all functional groups who have data protection responsibility, marketing responsibilities, or need to understand the basics

William Mack Copeland

$299

Managing Risk Within Your Supplier Management Program Live Webinar

03 June In this webinar, we will unpack the latest FDA requirements for supplier quality assurance (SQA)

Tim Fischer

$229

Pharmaceutical Compressed Air Quality GMP Requirements - What you need to know to meet FDA and Inte

08 June This webinar will give you an understanding of the different types of contamination inherent in compressed air

Roger Cowan

$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

08 June This webinar will examine a variety of issues surrounding water in a facility to include the testing of each water source.

Barry A. Friedman

$199

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

$1,599

21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

03 Aug This webinar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records

Carolyn Troiano

$199

Best Practices for Deviation Training

MP3 Download -Duration 180 Minutes

Danielle DeLucy

$399

Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries

MP3 Download New Root Cause Analysis Techniques and CAPA Management live webinar is for those in Operations, Facilities , Engineering and QA/QC

Meena Chettiar

$179