Brian G Rosenberg
Product Id: 704051
This training program will detail how to create a bullet-proof AP operation that is setup to detect and proactively prevent fraud from occurring. During this session, the webinar presenter will discuss real cases of AP fraud and the controls that organizations later realized needed to be added to their AP operation, unfortunately too late to prevent these costly incidents. In addition to discussing good controls, he will also discuss common controls that are ineffective, provide no value, or even leave AP departments with a false sense of security while they are in reality still very much exposed.
Product Id: 700162
This webinar on Process Validation Requirements will go over the foundations of process validation, with an emphasis on going beyond compliance to achieve a robust process. Review of the fundamentals of process validation, with an emphasis on looking beyond compliance to achieve a robust process.
Healthcare Fraud Webinar - False Claims, Stark, Anti-Kickback Statute, and Civil Monetary Penalties Law
William Mack Copeland
Product Id: 703413
This webinar will explain the Civil Monetary Penalties Law (CMP) and its mandatory and permissive exclusions and penalties. It will also cover obligations under EMTALA, violations of the Anti-Kickback Statute and Stark including amendments under the PPACA.
Qualification of Process Analytical Technology (PAT) Based Control Strategies for Batch & Continuous Manufacturing
Product Id: 706771
This seminar will provide an insight into the practical aspects of the Process Analytical Technology (PAT) batch and continuous manufacturing of pharmaceutical products. You will learn about regulatory initiatives to improve the quality of solid dosage pharmaceutical manufacturing using PAT. No special technical background is required.
Product Id: 706770
In this webinar, learn the best practices for avoiding common unfair labor practices (ULPS). It covers the many issues/challenges involved with impasse; bundling/packaging; internal and external influences; mediation; ratification; communicating during the final stages and post-agreement strategies; publication of the agreement and post negotiation training.
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Product Id: 703476
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
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.
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.
The Family & Medical Leave Act, California Family Rights Act & Pregnancy Disability Leave: Managing Employee Leave & Possible Abuse
Diane L Dee
Product Id: 706515
In the state of California, employers often struggle with abuse and fraud of protected leaves of absence as those granted by the Family & Medical Leave Act (FMLA), the California Family Rights Act (CFRA), and the Pregnancy Disability Leave Act (PDL). Employers feel uncertain how they can avoid complex leave of absence issues while protecting their own financial and business needs. The overlap between these pieces of legislation is often confusing and seemingly complicated. All three pieces of legislation provide ways in which an employer can identify an employee’s need for leave while vigilantly remaining alert to potential leave abuse.
Statistical Elements of Sample Size Calculations for Non-Clinical Verification and Validation Studies
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.
David L Osburn
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.
Product Id: 706648
In this webinar, you will get an overview of FDA’s medical device Quality System Regulation, 21 CFR Part 820.
Federal Oversight of Laboratory-Developed Tests in Limbo: What’s the Regulatory & Legislative Outlook for LDTs?
Product Id: 706769
This webinar will discuss the current status and outlook for federal oversight of Laboratory Developed Tests (LDTs) amid bureaucratic infighting during the COVID-19 pandemic regarding the authority of the Food & Drug Administration (FDA) to regulate LDTs.
John E Lincoln
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.
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.
Product Id: 706766
We all want to have a great generic portfolio, but all our competitors also want the same thing - so how do you make sure that you get the winners to market before they do? Do you go for supergenerics, OTCs, smaller volume niches that you can exploit at higher prices - or should you stick to higher volume staples even though margins might be tight? The webinar looks at product selection and who else in the organisation you need to involve to ensure that you get there on time – is it regulatory? production planning? purchasing? strategic planners? The answer is – all of them!
Product Id: 706765
Non-conforming material happens. And medical device companies must deal it. This 90-minute webinar will help you to make sense of confusing regulations and effectively deal with non-conforming material. You will learn where non-conforming material can occur and how to identify, segregate, control, and disposition non-conforming material. You will learn about when and how to conduct failure investigations and requirements for correction and corrective action. Join industry expert, Susanne Manz from Manz Consulting to learn the essentials of dealing with non-conforming material and performing effective failure investigations.
Product Id: 706104
Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies. In this webinar, learn how to take a proactive approach to stay ahead of these problems.
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.
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.