Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences PART I & PART II
Robert J Russell
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.
Webinar - Latin America – Understanding Regulatory Compliance Requirements Across Life Science Industry PART I & PART II
Robert J Russell
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.
Japanese PAL – JPAL Technical, cultural and language challenges when dealing with MAH, PMDA, Distributors and Customers
Phil Smart
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.
Fix Your Supply Chain Compliance Nightmare: Complimentary Webinar
Craig Isaacs
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.
21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
David Nettleton
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).
Current Regulatory Requirements for Aseptically Produced Products
Kenneth Christie
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.
HIPAA Compliance for Electronic Records
David Nettleton
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.
The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications
Ana Maria Saaibi
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.
Best Selling Medical Devices webinars
John E Lincoln,Edwin L Bills,David Dills
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.
Best-selling cGMP/Regulatory/Compliance Training CDs for the Microbiology Lab
Frank Settineri,Jim Polarine
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.
FDA Compliant Marketing/Promotions for Pharmaceutical Companies - Best Selling Package Webinar
Mark DuVal,Mark Gardner,Alfredo J Quattrone
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.
Pack of Four: Best selling Lab related webinars
Dr. Ludwig Huber
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.







