WEBINARS

 

Compliance Training Webinars for Regulated Industries

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FDA Inspection Primer - Comprehensive Training Course Package (5 Courses)

webinar-speaker   Martha Bennett ,Dr. Ludwig Huber,Jeff Kasoff,John E Lincoln,David Dills

webinar-time  

Product Id: 702294

This comprehensive FDA inspection training package consists of five training webinar recordings covering everything from preparing for FDA inspections to responding to FDA Form 483s and warning letters.

Recording Available

* Per Attendee $899

 

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

 

Establish Change Control for Pharmaceutical Stability Program

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 702968

This webinar on pharmaceutical stability program will discuss the types of CMC changes in the life cycle of a pharmaceutical product and how it affects the stability program.

Recording Available

 

Full Day Virtual Seminar : Annual GLP Refresher Webinar

webinar-speaker   Nanda Subbarao

webinar-time  

Product Id: 701862

Recording Available

 

Stability Program to Support Shipping and Distribution of Drug Products

webinar-speaker   Kim Huynh-Ba

webinar-time  

Product Id: 701678

This training on pharmaceutical stability studies will highlight the key factors that would affect the shipping and distribution of drug products. It will explain the stability studies that need to be done to support shipping and distribution of drugs.

Recording Available

 

Understanding Disinfectant Qualification Studies - How To Avoid Errors

webinar-speaker   Ziva Abraham

webinar-time  

Product Id: 701580

This training on disinfectant qualification studies will discuss the many methods and variations used for disinfectant qualifications, the pitfalls in each method, the errors that can occur and how to identify them. It will show how you can translate the disinfectant qualification results to effective cleaning procedures and avoid FDA observations.

Recording Available

 

Quality Practices for Research and Development (R&D) CMC Laboratories

webinar-speaker   Nadine M Ritter

webinar-time  

Product Id: 701513

This Quality Practices for R&D CMC Laboratories training will associate with generating, reviewing, utilizing or contracting analytical studies for pharmaceutical product development.

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

 

From Premarket Notification to Recalls - Comprehensive Medical Device Regulations Training Package

webinar-speaker   Daniel O Leary,Judy M Andrews,John Chapman,Jeff Kasoff,John E Lincoln,Bob Michalik, JD, RAC Michalik,David Dills,E.J Smith

webinar-time  

Product Id: 702205

The following is a pack of 8 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance in the important stages of device development, marketing and maintenance.

Recording Available

* Per Attendee $799

 

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

 

Clinical Trials Monitoring - Comprehensive Training Package (4 Courses)

webinar-speaker   Carol Owen,Kimberly Kiner,Arash Amirpour,Charles H Pierce

webinar-time  

Product Id: 702298

This comprehensive training package of four courses covers clinical trial monitoring techniques, audit procedures and the setting-up of Data Monitoring Committees (DMCs).

Recording Available

* Per Attendee $499

 

Food Preservation & Packaging - Comprehensive Training Package (5 Courses)

webinar-speaker   Dr. Tatiana Koutchma,Thomas J. Dunn,Atique Rehman

webinar-time  

Product Id: 702295

This food preservation and packaging comprehensive training package of five courses is aimed at food manufacturers and covers US and EU regulations related to alternative food preservation techniques and food contact packaging.

Recording Available

* Per Attendee $649

 

Risk Management and Business Continuity - Comprehensive Training Package for Risk Professionals (5 Courses)

webinar-speaker   Bill Greulich,James Bone,Connie Valencia ,Anne M. Marchetti

webinar-time  

Product Id: 702246

This comprehensive training package of five courses will help risk professionals and compliance officers understand the shifting paradigms of risk management, how to implement business continuity programs and the financial issues in emergency management.

Recording Available

* Per Attendee $1679

 

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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