Product Id: 706024
This webinar provides participants with practical guidance in implementing an effective operational risk management system. It will also bring you up to speed on current best practice in the field of managing operational risk in financial institutions. Not only will we examine the details of each of these principles, as well as taking an all-inclusive look and what needs to happen to implement them; we will complete our journey by examining the principles under the harsh light of an actual Case Study in the banking industry.
John E Lincoln
Product Id: 701662
This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.
Product Id: 705360
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.
Product Id: 706101
Data Integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.
John E Lincoln
Product Id: 706873
The definition of labels is well defined and ususally well known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinar.
Product Id: 706865
This session will review guidance from the HHS Office for Civil Rights (OCR) and from the National Institute of Standards and Technology (NIST) about how to properly de-identify health information. The various needs for de-identified information will be discussed and typical questions covered in the guidance will be discussed, in order to provide a sound, defensible basis for an organization’s decisions and processes surrounding de-identification of PHI. Attendees will be able to go forward with de-identification with greater confidence, and better sharing of information will be possible.
Product Id: 706866
This course covers the basic concepts of Enterprise Risk Management and key elements that finance executives and personnel need to be aware of when implementing ERM across their organizations.
Donna K Olheiser
Product Id: 706803
This session will help the attendee to identify a Third-Party Sender (TPS) and a “nested” TPS. In addition, we will cover the details needed in the agreements between all parties and what parties based on their role. Discussion on the registration requirement for both the TPS and the nested TPS and what that means to the ODFI.
David L Chesney
Product Id: 706869
This webinar will cover the requirements for laboratory controls under US GMP regulations, such as those relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues.
John E Lincoln
Product Id: 706874
This presentation focuses on the verification and validation planning and execution of software, used in medical device manufacturing, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf), custom, and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) Production / Test, and 2) QMS / 21 CFR Pt. 11, and 3) Cybersecurity / Networked systems. Examples will be demonstrated. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.
Product Id: 701582
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
Assaults, Murder - A Major Problem in Healthcare Across the U.S.: What is Your Healthcare Organization Doing to Effectively Prevent & Respond to the Violence?
Dr. Susan Strauss
Product Id: 704727
The healthcare environment creates a major challenge in the prevention and intervention of violence. The rate of injuries and illness from violence in the healthcare industry is more than three times greater than violence in all private industry. This training program will explore what makes violence in healthcare unique and its negative ramifications on quality patient care.
Product Id: 703871
This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.
John E Lincoln
Product Id: 706875
Remote QMS-CGMP compliance inspections are here to stay. Add it to your toolbox for vendor and remote site audits, especially for low to moderate risk companies.
Product Id: 706773
An ethics and compliance risk assessment is the foundation of an effective ethics and compliance risk management program. This detailed course provides a 12-stage framework that will help you complete your own ethics and compliance risk assessment. The 12 stages are divided into two components, the Planning Phase and the Implementation Phase. With a completed ethics and compliance risk assessment and armed with your findings and action plan, you will be equipped to develop and implement an effective ethics and compliance risk management program.
John E Lincoln
Product Id: 701742
This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.
Product Id: 706070
This 1-hour webinar will go into the specifics of the REACH and RoHS regulations and review the latest amendments and changes to both regulations for 2023. We will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.
Product Id: 706863
This course provides guidance in how to implement and maintain the desired level of credit risk management with practical tools and techniques. Both the market and the regulatory agencies expect credit risk management to reflect the bank’s credit culture, so the class also offers direction on how to identify the organization’s credit culture and to reposition it to support the desired credit risk culture and management.
Ginette M Collazo
Product Id: 706862
This course offers practical approaches and tools to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.
Product Id: 704333
This webinar will prepare your staff for this filing year, improve your employee reporting set-up and maintenance practices, and reduce your risk of complaints from the IRS. Learn the latest updates on Form W-4 and Form W-2 wage and withholding reporting.