Compliance Training Webinars for Regulated Industries

This will teach part 1 of defining and refining objectives and selecting the best of alternative courses of action.

The importance of GLP compliance, as well as preparing an FDA-ready IND package will also be presented. This webinar will be valuable for anyone developing cell, tissue or gene therapy products, including those in the biopharmaceutical industry.

This webinar will provide valuable assistance to regulated companies which employ regulatory affairs associates, clinical specialists, internal auditors, audit managers and personnel of JPAL-regulated medical device or IVD companies. A comprehensive audit of relevant clinical investigations is now expected to determine if the clinical trials and clinical trial systems are effectively documented and implemented.

This presentation will start with a review of the requirements for C-TPAT by member type and explain in detail what the validators are looking for at your company. Every member of the Customs and Border Protection’s C-TPAT program will go through validations.

In this webinar, we will review basic FDA expectations for evidence of adequate analysis and testing to identify the severity and likelihood of use errors, and validation of risk mitigations through usability testing with representative users. As applied to the overall Design Controls process phases, will be presented.

This webinar will provide valuable assistance to all regulated companies that need to validate their systems The series will deal with Operational Qualification (OQ), Performance Qualification (PQ), and maintaining a state of validation using statistical methods associated with Six Sigma

This webinar will provide valuable assistance to all companies that are required to maintain an OSHA 300 Log. This seminar will teach you how to analyze cases to produce accurate OSHA 300 Logs.

This OSHA compliance training will cover all the requirements of OSHA training that a medical practice or facility is required to provide.

AN overview of the Part 11 regulation, with special emphasis on the key role played by the applicable predicate rules as the starting point for any Part 11 compliance assessment. In spite of the FDA’s clarification regarding the scope of electronic records subject to Part 11 as expressed in the Sep 2003 Guidance for Industry, much discussion and debate still surround the topic.

This seminar presents the basics of Quality by Design in such a way as to allow attendees to understand Quality by Design as it applies to their company and their products. Six years after the announcement of the FDA’s cGMP Initiative for the 21st Century, the FDA has finally coalesced on an approach it calls “Quality by Design.” Despite numerous presentations by FDA officials, several pilot programs and the adoption of Quality by Design by the International Conference on Harmonization (ICH), confusion about Quality by Design reigns throughout the pharmaceutical, biotechnology and medical device industries.

This webinar will provide valuable assistance to internal auditors, audit managers and personnel of regulated medical device or IVD companies. This presentation will provide an understanding of the tools of risk management and how to integrate risk management into an effective internal audit program.

IT Guidance from COSO on how to deal with IT controls. Learn how to use Small COSO templates for IT and leading practice...

Learn how to use and how far to go with an effective and efficient approach for your CAPA investigation. This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner.

This program will be helpful for those who must develop Risk Management processes for Pharmaceutical companies. This seminar will discuss how to make Risk Management an integral part of the processes of process design and manufacturing for the industry.

The workshop will provide guidance on the roles and responsibilities of each functional area in the company and how they relate to each other. Each company must demonstrate full implementation of the quality system by providing appropriate training and re-training when necessary, for its employees.

This webinar will provide valuable assistance to all medical device and IVD companies that must comply with domestic and international regulations for their quality systems. Most notable of these would include USA (21CFR820), Canada (CMDR + ISO 13485), Europe (MDD Annex II.3 + ISO 13485) and Japan (JPAL Ordinance 169 + ISO 13485).

This webinar will provide valuable background for those who need to evaluate viral clearance data.

The mutually exclusive roles for Quality Assurance and Quality Control in validation will also be discussed. Across 20+ years of global regulations and guidance related to computer systems, there are four common themes that provide the foundation for auditable validation efforts.

This webinar will provide valuable assistance to all regulated companies that need to audit any department, process or procedure, financial records, assets, etc. This program will look at the formation and interpretation of the ICQs, narratives, flowcharts, as well as the proper design for the audit steps.

This webinar will provide valuable assistance to all companies regulated by FDA to understand the current and impending requirements for electronic submissions. The immediate impact is to companies submitting INDs and marketing applications for pharmaceutical and biological products.