
On the Alert: Crafting an Effective Incident Response Plan (IRP)
Robert Davis
60 Min
Product Id: 706693
In today’s world, every organization no matter how large or small needs an Incident Response Plan in place to quickly manage and address the consequences of a breach. The volatility of today’s threat landscape makes an incident response (IR) more challenging than ever. This webinar is designed to give information security professionals an overview of the various considerations and aides in IR planning.

Lone Worker Safety Compliance
Michael Aust
120 Min
Product Id: 706399
Did you know that every employer, regardless of industry, has the potential of an employee working alone? Regardless if the employee is working alone for an entire shift, partial or a very small percentage, providing safety for that employee is essential for meeting regulatory compliance.

Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
Elaine Eisenbeisz
90 Min
Product Id: 706650
This webinar provides the logic and processes for determining samples sizes for common tests used in verification or validation of processes. The focus of this webinar is on providing the information needed for attendees to know the appropriate measures and formulas to use for the determining sample size and providing justification for the planned sample sizes.

Calculating the Z-Score "Bankruptcy Predictor" Model
David L Osburn
90 Min
Product Id: 705795
This webinar will teach how to calculate the Z-score and “correctly” interpret it based on a straight-forward scale. Five-step “key ratio analysis ” plan (liquidity, activity, leverage, operating performance, and cash flow analysis) will be displayed and tied into the comprehensive calculation of the Z-score. The session will conclude with a review of using sophisticated software such as Moody’s Lending Cloud to calculate both the Z-score and key ratios.

Introduction to Medical Device Quality System Regulations
Paul Larocque
90 Min
Product Id: 706648
In this webinar, you will get an overview of FDA’s medical device Quality System Regulation, 21 CFR Part 820.

Validation Master Plan - The Unwritten Requirements
John E Lincoln
60 Min
Product Id: 705877
This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, 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.

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation
Charity Ogunsanya
90 Min
Product Id: 703875
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.

An Update on Discharge Planning Rules and Regulations for 2022
Toni Cesta
60 Min
Product Id: 705120
In this program we will start by reviewing the current rules for discharge planning. Are you compliant with these rules? The newly enacted rules that are now required under the Medicare program’s conditions of participation will be reviewed as they may have a profound effect on how case management departments organize their work. Family caregivers and physicians are expected to be much more involved than they have in the past. This program will review the current rules and regulations from the Conditions of Participation (CoP) for Discharge Planning.
Be sure you know the old rules and the new rules so that your practice will be current and legal! We will review strategies for integrating these requirements into your daily practice.

Implementing a Robust and Compliant Change Control Program
Kelly Thomas
90 Min
Product Id: 705909
This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough change control program; as well as, discuss the elements regarding successful management an effective Change Control system.

HIPAA Breach Evaluation and Reporting - What Qualifies as a Reportable Breach and how to Report It
Jim Sheldon-Dean
90 Min
Product Id: 705214
There are several steps that must be taken to determine if an incident is a breach, and whether or not that breach is reportable. Determining whether to report or not is not necessarily straightforward, but there are guidelines to follow to help at every step of the way. If the evaluation of necessity to report is not done correctly, you may not make the right decisions about reporting and be subject to penalties for non-compliance upon an investigation of a breach by HHS. Penalties for non-compliance can up to millions of dollars in cases of willful negligence, so it is essential to evaluate incidents to see if they are reportable breaches, and act properly on the evaluation.

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
Roger Cowan
60 Min
Product Id: 703727
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

MS Excel: Advanced Pivot Tables for Superior Data Analytics
Joe Weil
90 Min
Product Id: 705379
Pivot Tables are one of the most powerful tools in Excel’s arsenal of data analytics. With just a few clicks, and no complicated formulas or macros, you can quickly and easily build incredibly informative reports, charts and dashboards. In this webinar, you’ll learn Pivot Table techniques that will instantly filter, summarize and analyze huge amounts of raw data. You will learn to use advanced Pivot Table techniques to rapidly produce critical information that will highlight the algorithms and trends buried in reams of data.

How to Conduct a Human Factors / Usability Validation
Jose Mora
60 Min
Product Id: 706764
In this webinar, you will learn why the FDA requires several validation participants from each “distinct user population”. Learn why the FDA requires many validation participants from each "different user demographic" in this webinar. We'll go over how to determine which tests to run and which studies to finish before the actual validation test.

Understanding Environmental Social and Governance (ESG) and its Compliance
Stanley Epstein
120 Min
Product Id: 706763
Environmental, Social, and Governance (ESG) has gained increasing attention over the past few years. Today many institutional investors will only invest in those companies that provide ESG performance reporting. ESG provides a set of standards for a company’s operations that today’s socially conscious investors use to screen potential investments in terms of how a company treats the environment, manages social issues (relationships with employees, suppliers, customers, and the communities where it operates), and deals with governance issues.

The Disruptive Practitioner: A Danger to the Hospital's Operation
William Mack Copeland
60 Min
Product Id: 703888
In this training program, attendees will discover how to create a record of disruptive behavior and the efforts taken by the organization to combat the problem. The webinar will also illustrate why such disruptive behavior can be a continuing problem; and therefore, why appropriate documentation is imperative.

Process Analytical Technology (PAT): The Impact on Pharmaceuticals Manufacturing and Validation Needs/Requirements
Michael Levin
60 Min
Product Id: 701147
This webinar will provide an insight into the practical aspects of the Process Analytical Technology (PAT) and will be an invaluable source of information on various technologies and approaches that fit the PAT definitions. You will learn about regulatory initiatives to improve the quality of pharmaceutical manufacturing using PAT and validation thereof. No special technical background is required.

How to Implement the FDA SUPAC Guidance
Michael Levin
60 Min
Product Id: 704312
This webinar training will cover various topics on Scale-Up and Post-Approval Changes (SUPAC). Participants will learn how to properly scale-up or scale-down pharmaceutical batch process and learn the standard set of documentation to successfully support post-approval changes.

How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities
Carlos M Aquino
90 Min
Product Id: 704617
The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.

Non Resident Alien Payee (1042-S, W-8) - How to Handle the Information Reporting and Backup Withholding Requirements of the IRS
Miles Hutchinson
120 Min
Product Id: 703855
In this training program attendees will learn how to manage nonresident alien payee' tax issues in compliance with IRS information reporting and backup withholding requirements for NRAs. Also attendees will learn the five variations of forms W-8 including the new W-8BEN-E just released in Q1-2014. It will help attendees establish which W-8 to provide NRAs working for them.

CGMP controlled Raw Materials
Charity Ogunsanya
90 Min
Product Id: 705148
This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.