Oct 18-20, 2021 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.

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

$4,665

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

$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

$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

$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

$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

$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

$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

$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

€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

$5,995

FDA Regulatory Compliance for Drug and Biotech Product

Oct 28-29 ,2021 at 11:00 AM - 05:00 PM EDT

Karl M. Nobert

$6,000

FDA Compliance and Enforcement Trends focused on Data Integrity

29 Oct This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits

Carolyn Troiano

$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

$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

$399

Supervising a Human Error Free Environment: You can do a Lot More than you Think

04 Nov How can we prevent human error? This 90 -minutes online course will discuss why supervision is so important in reducing and preventing human error

Ginette Collazo

$179

A Culture of Quality is a Competitive Advantage

04 Nov This webinar will help you to imbed a culture of quality throughout your organization. We will discuss concepts for creating a culture of quality

Susanne Manz

$229

GMPs for the Life Sciences – 12-Hour Virtual Seminar

November 04 - 05 This training will provide foundation to your GMP training.

Charles H. Paul

$4,995

Analytical Method Validation, Verification and Transfer

Nov 08-09 In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures

Kelly Thomas

$1,498

FDA Recalls - Before You Start, and After You Finish

On 08 - 09 Nov, 2021 this seminar will help you to Understand FDA's recall authority and policy , Learn how to manage recalls under FDA oversight.

Kelly Thomas

$1,295

FDA Recalls - Before You Start, and After You Finish

On 08 - 09 Nov, 2021 this seminar will help you to Understand FDA's recall authority and policy , Learn how to manage recalls under FDA oversight.

Kelly Thomas

€1.595

U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs

On 09 November 2021 This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3

John E Lincoln

$499

Dealing with Out of Specification Test Results in FDA Regulated Industries

09 Nov This webinar with a thorough knowledge on what is allowed and what is not allowed and areas that need to be looked at for a thorough investigation of all

Meena Chettiar

$199

Excel Spreadsheet Validation-Step-by-step guide to data integrity compliance

17 Nov This session will make you a better Excel user, saving you time and costs

David Nettleton

$199

Data Integrity: FDA, WHO and EMA's Requirements

Nov 15-16 This two day seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program

Barry A. Friedman

$1,495

Project Management for Non-Project Managers

01 - 03 Dec This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective

Charles H. Paul

$1,495

Purchasing Controls and Receiving Acceptance for Medical Devices

02 Dec This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products

Susanne Manz

$229

The Veterinary Drug Approval Process and FDA Regulatory Oversight

02-03 Dec This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government

Karl M. Nobert

$1,495

Statistics for Process Control

07 Dec This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products

Elaine Eisenbeisz

$795

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

December 13-15th 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

$1,295

Computer System Validation Professional Certification Program 3 Days

Dec 13-15 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

$1,899

DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements

MP3 Download This Webinar will discuss the latest U.S. FDA and European Union requirements on Design History File, and Technical File/Design Dossier

John E Lincoln

$199

Write it Right – Standard Operating Procedures

MP3 Download this webinar will help you to write complete, clear, unambiguous, and flexible SOPs.

Susanne Manz

$487

Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course

15-16 Dec Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit inspection, overview of the European Medicines Agency's Guid

Michael Ramcharan

$2,995

Technical Writing for professionals in the life sciences

MP3 Download 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

$1,495

Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies

MP3 Download This webinar will provide a step by step approach and valuable tips for setting up a Quality System to withstand FDA Audits

Meena Chettiar

$199