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.
Data is an organization’s biggest asset. For clinical research billing programs, an organization’s revenue data can be a vital resource to strengthen controls and mitigate risk. This course will focus on leveraging denials data to strengthen the coverage analysis development and an organization’s clinical research billing program. You will learn to utilize the rich data in an organization’s clinical research revenue cycle to strength controls and mitigate risk.
This webinar will focus on regulatory requirements, optimal processes and define the difference in collaboration with both internal and external physician advisor roles. It will also discuss the role of the physician advisor and staffing needs to implement this important role.
Hygienic Design in food processing is a given, however FDA’s #483 violations continue to reflect organizations clearly lack the necessary requirements to maintain safe environments for food production. This course will outline the basics food facilities should have in place and how to ensure program meets FDA’s expectations.
Learning how to create Pivot Tables is one of the must have skills for anyone who needs to use Excel to quickly build reports and summaries. This webinar will provide you with a solid foundation that you can use to build your own Pivot tables and reports.
This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program. The introduction will give an overview about the requirements for the quality management system and how to conduct an internal audit with MDSAP requirements to check, if your quality management system meet all MDSAP requirements.
In this webinar Banks and Credit Unions (Financial Institutions) will gain a core understanding of the BSA/AML risks, risk mitigation techniques and potential rewards of banking MSBs. This course is designed to assist Financial Institutions in formulating their strategy for banking MSBs, regulatory bodies overseeing MSB compliance, income and expense characteristics in banking MSBs, balance sheet impacts, perceptions and misperceptions of MSBs, risk between MSB entities and how to strengthen your financial institution’s BSA/AML program.
Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.
This webinar will discuss what are Mycotoxins, classifications, contamination methods, the Regulations & Recommendations on Maximum Mycotoxin Levels, the risk management and prevention strategies to identify and control the contamination. You will learn the best agriculture practices, storage practices, dispatch and transport practices to prevent contamination.
Managing case management outcomes and the creation of tools with which to study those outcomes is an important component of the work that case management professionals must engage. This data helps us better understand where we are doing well and where we might need to improve. Case management report cards are also a useful tool for reporting data to the Utilization Committee, a requirement under the CMS Conditions of Participation for Utilization Review.
This HR compliance webinar will discuss salary history laws and the steps employers should take to remain compliant during hiring process. Attendees will learn prohibitions mentioned under Salary Ban Laws and how to avoid discrimination in pay equity.
This webinar will review not only the Anti-Kickback Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior.
This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need to understand the methodologies used by FDA during inspections. During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used by the FDA is clearly of high importance.
This webinar will discuss common deficiencies that are discovered in compilation and review engagements, as a result of peer review. It will explain the difference between minor deficiencies and major deficiencies. Instructor will discuss how to avoid these common mistakes and what the most common deficiencies are.
The root cause of variable or inconsistent data from compendial dissolution tests can be difficult to identify. Formulation, equipment, operator error and incorrect calculation may be factors. This webinar presents a systematic, logical approach to investigating anomalous dissolution results.
Organizations engaged in clinical research activities are exposed to risk and must develop risk mitigation strategies. This course is designed to provide attendees with strategies to mitigate the risk and develop controls to ensure a compliant clinical research billing program. Attendees will learn various control strategies and leading practice within a clinical research billing program.
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also consider areas where FDA will likely focus their effort, including on the higher-risk systems. It will cover areas that will help you to plan for an on-site inspection.
What are the rules regarding how you may contact a debtor? They are so complex and confusing! There are many issues involved, such as what questions you may and may not ask someone other than the debtor and restrictions on what you can leave in voicemail or send in an email, and the best ways to handle suspected deadbeats. What is the best practice for postings to open accounts when the debtor may file bankruptcy? Did you know that medical collections must be treated with more care than consumer collections? Learn the answers to all of these issues and your own questions when you attend this detailed presentation of the FDCPA.
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
This 2-hr webinar will review the FDA and FTC regulations for promoting and advertising dietary supplements, walk you through real-life case studies, help you address compliance, and tell you how to respond to an FDA enforcement action.