Compliance Training Webinars for Regulated Industries

This SQM webinar will discuss how to establish a Supplier Quality Management program from selection to approval, the ON-going maintenance and disqualification of suppliers will be explored through definition of supplier classifications. How to build risk management into the process will be discussed. The webinar will explore the use of Quality Agreements to manage suppliers.

This course on 510K documentation for software or software enabled device will detail what Medical Device companies need to know what Software Specific documentation needs to be prepared for successful 510K submittals to avoid delays or denial of the 510K approval. it will discuss key to comply with IEC62304, FDA guidance with in software development and verification/validation process.

This CAPA evaluation, implementation and integration webinar will discuss FDA regulatory requirements, how to evaluate your CAPA system, how to integrate with QMS and the best practices approach to initiation, evaluation and implementation of CAPA system along with discussion about CAPA documentation requirements.

This risk assessment training will discuss why it is essential to perform a risk assessment and what kind of breaches can occur. It will also list what HIPAA regulations require and what it should tell you.

In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process.

In this webinar the presenter will review the known and anticipated 2019 MIPS requirements for 2019 at a detailed level. It will also address how the Bipartisan Budget Act of 2018 will impact planning and performance in the MIPS in 2019. Discussion will be on the best practices for performance in each of the 4 MIPS performance categories at a granular level, including quality measure selection, implementation and performance tracking, strategies designed to obtain 100% scores on the Promoting Interoperability (formerly Advancing Clinical Information) and Improvement Activity categories, and optimizing performance in the Cost category of MIPS.

This OSHA 300 log recordkeeping webinar will discuss the new injury recordkeeping E-submission rule requirements & a basic review of recordkeeping in terms of site specific case scenarios will be presented.

This webinar will discuss the fundamentals requirements for system which gets audited during FDA inspection and how to conduct internal audit, report writing and audit follow ups.

This webinar provides initial guidance on how to build a cybersecurity recovery program that includes FDA CAPA elements. The training will address how to prepare a firm's staff for cybersecurity problems. Remember, people carry the biggest "open door" for a hacker. You can use FDA's optional follow-up options. Finally, you can take away a basic checklist that a cybersecurity audit team should include in their program. It is a start from which you can further develop and refine a cybersecurity program as you gain experience.

The course is designed to review critical elements of the new regulations and is suitable for clinical, regulatory and quality leaders. The course is suitable to anyone who is new to Medical Devices, in addition to those who would like to further their working knowledge of current requirements.

Extracting data from text files or from database management systems, such as Microsoft Access or Microsoft SQL Server, can be intimidating to Excel users. In this informative session, Excel expert David Ringstrom, CPA, walks you through the process of getting the data you need from databases or from text files into Excel.

This webinar will assist in analyzing and interpreting your agency reports (CASPER Reports, 5-star ratings) and provide clinicians OASIS item-specific guidance such as item intent and response instructions which helps in improving patient outcome measures.

Join this webinar which will discuss current, expert, and applicable knowledge about the responsibilities, functions, and management of SAE reporting and medical safety for a clinical trial. The procedures for SAE reporting will be discussed which should be contained in company SOPS and well organized with regard to staff assignments and responsibilities before a trial begins to assure all responsibilities are covered.

This 90-minute training will discuss the requirements of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Attendees will also learn the requirements for changing specifications through the lifecycle of the product.

Understand the requirements for investigations when dealing with pharmaceutical drug substances and products; to understand how to effectively control and conduct a laboratory investigation for unknown causes.

This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do’s and don’ts with HIPAA.

This operational efficiency webinar will describe the various aspects of improving your operation by comparing what operational laggards and leaders do through examples in the from of eight mini case studies covering basic metals, electric equipment, medical specialties, food & distribution etc.

This webinar will teach you all the requirements that must be in place for the HIPAA Security Rule and how to demonstrate compliance with all the required and addressable safeguards. After completing this course, a Covered Entity or Business Associate will be able to know what needs to be place when it comes to all of the HIPAA regulations.

This webinar will address the concerns within the financial services industry, and identify the recent cybersecurity regulations of China, Singapore, the EU, and the U.K. Attendees will gain an understanding of cybersecurity practices and how to create a cybersecurity report. Detail of some current issues with implementing cybersecurity programs. Current best practices in cybersecurity. The main area of cybersecurity and regulation will be discussed as well as methods to ensure compliance.

This training program will highlight the steps for conducting disciplinary investigations. It will discuss how to hold employees accountable for sustained change and detail a simple system for determining how to coach employees. It will also focus on Performance Improvement Plans (PIPs) and how progressive discipline policies can hurt you.