WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I & PART II

webinar-speaker   Robert J Russell

webinar-time  

Product Id: 701349

This JAPAN Regulatory compliance training is designed to provide an overview of the regulatory environment in Japan with respect to regulatory filings and registrations.

Recording Available

* Per Attendee $399

 

Webinar - Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I & PART II

webinar-speaker   Robert J Russell

webinar-time  

Product Id: 701350

This Latin America Regulatory compliance requirement training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

Recording Available

* Per Attendee $299

 

Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers

webinar-speaker   Phil Smart

webinar-time  

Product Id: 701292

This (JPAL) Japanese Pharmaceutical Affairs Law training will go into the unique challenges facing the Foreign Manufacturer when working with the Japanese.

Recording Available

 

Fix Your Supply Chain Compliance Nightmare: Complimentary Webinar

webinar-speaker   Craig Isaacs

webinar-time  

Product Id: 704565

This webinar training will explain how to efficiently manage third-party and supply chain risk with the Common Controls Hub.

Third-party and supply chain compliance risk management is mandated for most organizations. However distributing, reporting, and tracking of adherence to control lists is so painful that many organizations do not perform due diligence at all or with the necessary frequency. Participants will learn how to self-assess their compliance and Internal controls.

Recording Available

 

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s

webinar-speaker   David Nettleton

webinar-time  

Product Id: 704533

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

Recording Available

 

Current Regulatory Requirements for Aseptically Produced Products

webinar-speaker   Kenneth Christie

webinar-time  

Product Id: 704791

The manufacture of sterile products and the risk they represent to the public is always on the fore front of inspectors during regulatory audits. As a result, the manufacture of sterile products require a high degree of control of incoming materials, the manufacturing process and the control of personnel to name a few. A weakness in any of these items can jeopardize the sterility assurance of the final product. This training program will highlight and summarize the following main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

Recording Available

 

HIPAA Compliance for Electronic Records

webinar-speaker   David Nettleton

webinar-time  

Product Id: 704422

This HIPAA training program will highlight electronic record security regulations including requirements for security, data transfer, audit trails, electronic signatures, digital pens, and biometric signatures.

Recording Available

 

The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications

webinar-speaker   Ana Maria Saaibi

webinar-time  

Product Id: 703688CD

Each 510(k) submission poses a new set of challenges and new variations, depending on the type of device, the risk level, and its history. Therefore, it is essential to have a strong understanding of the most up-to-date 510(k) submission requirements and how they relate to your device for the most efficient submission process. This course will elaborate device classification, overview the 510(k) program, and discuss FDA submissions.

Recording Available

 

Best Selling Medical Devices webinars

webinar-speaker   John E Lincoln,Edwin L Bills,David Dills

webinar-time  

Product Id: 700961

This pack of 4 courses contains some of our best selling Medical Device webinars which together cover the essential compliance challenges faced by Medical Device companies today. ComplianceOnline brings you a special Medical Devices training primer. A package of 4 of our best selling Medical Devices webinars- available at a 50% discount.This pack of 4 courses contains some of our best selling Medical Device webinars which together cover the essential compliance challenges faced by Medical Device companies today.

Recording Available

 

Best-selling cGMP/Regulatory/Compliance Training CDs for the Microbiology Lab

webinar-speaker   Frank Settineri,Jim Polarine

webinar-time  

Product Id: 701819

The following training is a pack of 10 best-selling training CDs for the microbiology lab. These courses provide solutions for all critical challenges faced by microbiology lab professionals pertaining to regulations/compliance, best practices, quality, etc.

Recording Available

* Per Attendee $1099

 

FDA Compliant Marketing/Promotions for Pharmaceutical Companies - Best Selling Package Webinar

webinar-speaker   Mark DuVal,Mark Gardner,Alfredo J Quattrone

webinar-time  

Product Id: 701830

The following is a pack of 4 best-selling training CDs for sales, marketing & regulatory professionals in the Pharmaceutical industry. These courses provide solutions for all critical challenges & questions faced by you and your team pertaining to regulations/compliance, best practices, etc.

Recording Available

* Per Attendee $899

 

Pack of Four: Best selling Lab related webinars

webinar-speaker   Dr. Ludwig Huber

webinar-time  

Product Id: 700960

Clinical Labs are a tough environment to be in. Not only are there a multitude of rules, there are a number of areas which are not very clearly defined. On top of all this, the rules keep changing all the time. ComplianceOnline brings you a special clinical training primer. A package of 4 of our best selling Lab related webinars- available at a 50% discount.

Recording Available

* Per Attendee $699

 

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