Health and Environment Training Classes

Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Overview: Environmental Monitoring looks at the end results of the Environmental Control program - the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: "In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs." Therefore, ongoing environmental monitoring of a clean room environment is necessary to assure the quality and safety of the pharmaceutical product.

Overview: We often sample from a process or population in order to make an inference about the process based on the sample results. Selecting appropriate sample sizes often vexes many practitioners. This webinar discusses many issues present in any sample size determination. The webinar also discusses several common applications that require an appropriate sample size determination including estimation of product/process performance characteristics, hypothesis tests, acceptance sampling, Statistical Process Control charts, and reliability demonstration. When selecting sample sizes, it is important to align the statistical properties of the estimate or test with practical considerations. More data is not always better. Numerous examples are provided to illustrate the key concepts and applications.

Overview: Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and fixed. This course offers practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Overview: If, instead, you look deeper to figure out why the non-conformance is occurring, you can fix the underlying systems and processes that caused it. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the non-conformance occurred in the first place.

The Virtual Seminar explains how to apply statistics to manage risks and verify/validate processes in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 6 hours is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics Basic vocabulary and concepts, including distributions such as binomial, hypergeometric, and Normal, and transformations into Normality Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary recommendations

When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. So far there has not been an official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published a proposal for a general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. The new USP chapter will become official with USP 35. Now it is a good time to learn how to conduct and document method transfer. This seminar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation.

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. The webinar covers the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].

This 6 -hour virtual seminar will help you to develop a Quality Management System (QMS) for Medical Device Companies. A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient. The regulations require that manufacturers "establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured".

Overview: This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA HITECH is now fully enforced with bipartisan support and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump (or Biden) administration, new congressional mandates and any other applicable updates for 2021 and beyond along with changes relating to COVID19 and Information Blocking under the Cures Act (do’s and don’ts). There are an enormous amount of issues and risks for covered entities and business associates these days – we will speak to the most common violations and fines – and how to best avoid fines and headaches.

Overview: After a global pandemic, we are now experiencing a totally different way to think, work and travel. COVID-19 wreaked havoc on our workforce and our lives for over a year. Now that we are aiming to go back to some semblance of what we consider normal, managers are finding that the people they used to lead just aren't the same. Motivations have changed and how we need to manage, and lead need to change as well. This webinar covers the main issues behind the obvious changes in our workplaces as well as how to deal with the significant workplace culture shift. We will look at deal with different forms of personal, organizational and societal grief and PTSD from their grief.

Overview: Risk Analysis and Risk Management (RA-RM) are OCR's top enforcement priority and the basis for every HIPAA Compliance program. However, the biggest and most important nationwide HIPAA violation is failure to perform RA-RM in compliance with OCR requirements. OCR published shocking results of its Phase 2 HIPAA Compliance Audit on December 17, 2020 revealing that: 86% of covered entities and 83% of business associates failed the Risk Analysis Audit 94% of covered entities and 88% of business associates failed the Risk Management Audit

Overview: This session will focus on the rights of individuals to communicate in the manner they desire, and how a medical office can decide what is an acceptable process for communications with individuals. The session will explain how to discuss communications options with individuals so that you can best meet their needs and desires, while preserving their rights under the rules. With the new HIPAA random audit program now getting under way, and increases in enforcement actions following breaches, now is the time to ensure your organization is in compliance with the regulations and meeting the e-mail and texting communication needs and desires of its providers and patients. You need the proper privacy protections for health information, and the necessary documented policies and procedures, as well as documentation of any actions taken pursuant to your policies and procedures.

Overview: Have you spent thousands of dollars on locum tenens? Do you struggle to keep clinical professionals once you get them? This is the webinar for you. Whether you find it difficult to find professionals because of the pay scale you are dealing with, the area you are in, or the preconceived notions that may be out there about your organization, this webinar will discuss some of the best practices for finding and keeping your health care providers. Why you should Attend: This webinar will provide tools and suggestions for you to help recruit and retain medical, dental, behavioral health and other types of high demand medical professionals for organizations that are in difficult to recruit areas. This includes rural areas, high crime areas and low wage areas. Areas Covered in the Session: How do we find them? Medical Dental Behavioral health

This seminar concentrates on five areas of wage and hour law: paying exempt employees, calculating gross wages under the FLSA, deducting from an employee's wages, the nuts and bolts of physically paying employees and changing payroll frequencies. Why you should attend Join renowned payroll expert Vicki M. Lambert, CPP for this 5 and one-half hour "Boot Camp" format, Wage and Hour Training for Payroll Professionals! By knowing and understanding Wage and Hour requirements, you can help protect your company from what could be a major financial calamity. This includes not only how to do the basic math of calculating overtime (using the required FLSA method) but what hours must be paid for, what payment methods are legal in which states, how soon to pay an employee after closing out the timecard, and making sure exempt employees are paid on a "salary basis".

This 6-hour seminar 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. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. 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 regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers and what you guys need to do and how to best implement your HIPAA program based on over 18 years of personal experience working with Federal auditors, state auditors, and corporate auditors.

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices. Why you should attend Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA. GLPs are enforceable by law. They do not include manufacturing of product. GLPS are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system.

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files), which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.

Overview: Listen as Mr. Wolfe examines the new changes to the Stark and Anti-Kickback Regulations. He will discuss what these changes mean and what health care leaders should be doing now to position their organizations.