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.
Establish Change Control for Pharmaceutical Stability Program
Kim Huynh-Ba
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.
Stability Program to Support Shipping and Distribution of Drug Products
Kim Huynh-Ba
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.
Understanding Disinfectant Qualification Studies - How To Avoid Errors
Ziva Abraham
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.
Quality Practices for Research and Development (R&D) CMC Laboratories
Nadine M Ritter
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.
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.
From Premarket Notification to Recalls - Comprehensive Medical Device Regulations Training Package
Daniel O Leary,Judy M Andrews,John Chapman,Jeff Kasoff,John E Lincoln,Bob Michalik, JD, RAC Michalik,David Dills,E.J Smith
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.
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.
Clinical Trials Monitoring - Comprehensive Training Package (4 Courses)
Carol Owen,Kimberly Kiner,Arash Amirpour,Charles H Pierce
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).
Food Preservation & Packaging - Comprehensive Training Package (5 Courses)
Dr. Tatiana Koutchma,Thomas J. Dunn,Atique Rehman
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.
Risk Management and Business Continuity - Comprehensive Training Package for Risk Professionals (5 Courses)
Bill Greulich,James Bone,Connie Valencia ,Anne M. Marchetti
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.
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.