Good Manufacturing Practices and Audit Best Practices
Rama Rao
90 Min
Product Id: 705745
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.
Cybersecurity Exploitation Recovery for Medical Device Software
Casper Uldriks
75 Min
Product Id: 705729
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.
Overview of Medical Device Regulation in Europe
Rebecca Kemble
90 Min
Product Id: 705566
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.
Exploring Excel: Accessing Data from SQL, Databases and Text Files
David H Ringstrom
90 Min
Product Id: 705632
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.
Outcome Enhancement of Your Home Health Agency in 2018
Melissa Abbott
90 Min
Product Id: 705707
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.
AE (Adverse Event) and SAE (Serious Adverse Event) Reporting and Processing Procedures for Clinical Trials
Shide Badri
60 Min
Product Id: 705749
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.
Setting Specifications for Drug Substances and Drug Products
Peggy Berry
90 Min
Product Id: 704859
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.
Approaching Unknown Cause Laboratory Investigations Using Lean Tools
Barbara Berglund
60 Min
Product Id: 701905
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.
HIPAA Training for Security Officers
Brian Tuttle
60 Min
Product Id: 704350
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.
Transform from Operations Laggard to Operations Leader
Robert Sabath
60 Min
Product Id: 705724
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.
Understanding HIPAA Security Rule Requirements
Jay Hodes
60 Min
Product Id: 704877
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.
Banking Cybersecurity and Compliance: What You Need to Know
Vidia Ramdeen
60 Min
Product Id: 705728
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.
The Good, the Bad & the Ugly : A ‘How-to’ guide on Employee Performance Management - Module 3
Wes Pruett
90 Min
Product Id: 704747
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.
Developing an Operational Risk Appetite Statement
Mario Mosse
90 Min
Product Id: 703661
This webinar will discuss the challenges and opportunities involved in developing and implementing an operational risk appetite statement, which is supported by operational risk limits, and the determination of actual exposure against those limits.
Mitigate Fiscal Risks in Clinical Trials: Coverage Analysis, Budgeting and Billing Compliance
Marina Malikova
60 Min
Product Id: 705687
This webinar will discuss good clinical practice core principles and project management strategies applicable to financial aspects of clinical research during new biomedical product development process. Strategies and best practices to mitigate fiscal risks in clinical trials will be discussed i.e. coverage analysis, cost estimation, budgeting and billing Compliance.
Mastering AP Internal Controls: How to Reduce Risk and Prevent Fraud
Patrick A Haggerty
90 Min
Product Id: 704419
This webinar training will explain the process of internal controls in account payable operation as per COSO framework, why it is required and how to effectively implement it across organisation. Participants will learn how to master internal AP controls : preventive and corrective, to mitigate risk, ensure information system security and prevent fraud.
Root Cause Analysis and CAPA Controls for a Compliant Quality System
Ajit Basrur
60 Min
Product Id: 705698
In this CAPA webinar, learn various regulations governing Corrective and Preventive Actions (CAPA) and how organization should collect information, analyze information, identify, investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.
Payroll Employment Tax Compliance
Miles Hutchinson
90 Min
Product Id: 705709
This Payroll tax compliance webinar will discuss the tax obligations for an employer such as how to recognize employer’s income, employment tax withholding and reporting. The adequacy of internal controls to ensure tax withholding and reporting requirements. Review Form 941 and proper filing guidelines, the reconciliation process applied to the W-2's by the IRS and the Social Security Administration, processes for gathering withholding information from employees on Form W-4.
Advising Metrics: Emphasizing Methods Over Numbers to Meet Institutional Goals
Sue Ohrablo
75 Min
Product Id: 705720
This session will provide higher education administrators the tools they need to encourage student services professionals to strategically engage students in an ongoing and proactive manner to achieve institutional enrollment goals. The strategies discussed will help to reduce advisor push-back and resistance to student engagement initiatives and promote advisor engagement and accountability.
Cybersecurity: Safeguard Your Organization Against Cybercrime
Angela Bazigos
90 Min
Product Id: 705642
This cybersecurity course will teach you how to safeguard your organisation against cybercrime. By attending this webinar you will understand the new technologies, challenges and cybersecurity trends. It will also discuss the future trends and expectations.