Compliance Training Webinars for Regulated Industries

This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.

Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.

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).

Unauthorized transactions come in many different forms, when returning using Reg E or the Nacha Operating Rules can be confusing. Discussion will include what, why and when while processing unauthorized returns. The trainer will define the limits of liability and who is liable for what amount while providing some real-life scenarios. Details on the error resolution process with Reg E for consumer notification to the financial institution, research time involved, and the timing of providing provisional credit; included will be guidelines on the “what if” there is no error, and providing notice to consumer, and any overdraft protection relating to that provisional credit being reversed. Included will be outlining the ACH return process, when using the ACH network is appropriate, and paperwork/forms needed. Recent Rules changes affecting Nacha compliance when sending unauthorized ACH Returns using Return Reason Codes R10 vs. R11 is included.

This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.

This series of training programs on Family Care and Medical Leave in California will examine compensation while on leave, continuation of benefits while on leave, employer’s prohibited actions under the CFRA, employee’s return to work policies, and more.

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

Attend this training to understand all the requirements of the Toxic Substance Control Act (TSCA), its revisions, and how to develop a written plan, TSCA Training Plan. Get answers to your TSCA questions.

This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers.

In this informative webinar, you will learn how to properly account for and report expense reimbursements and facilities provided to employees in compliance with IRS requirements. Discussion includes work from home expense reimbursement.

Whilst Pivot Tables offer valuable data summarization features, they also have several limitations. They struggle with handling large datasets, they lack the ability to combine data from multiple datasets and the built-in calculation functionality is very simplistic.

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.

This 120 minute training course will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.

The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process; 510(k)s now can only be submitted to the FDA under the eSTAR (electronic Submission Template And Resource) Portal. Other submissions will be phased in using new guidance templates as they become available.

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.

Data protection and privacy is an important issue this day and age for the public. People want to make sure they are protected. With the rules & regulations for organizations becoming stricter as we move forward, this will help confidence with the public. GDPR will provide people with more control over their privacy and personal data. It’s essential to understand the various aspects and conditions, as well as the implications of wrongdoing for organizations. This webinar will focus on the core basics and then we will have a thorough discussion on protecting your institution.

The Family and Medical Leave Act (29 U.S.C. § 2601 et seq)- known as the “FMLA”- was signed into law by President Bill Clinton in 1993 in response to a growing national concern about balancing work and family responsibilities.

Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.