Financial Regulatory Compliance - Cybersecurity Policies
Lisa M Marsden
60 Min
Product Id: 706918
Navigate the complexities of SEC cybersecurity regulations with this focused 90-minute webinar. Gain insights into compliance strategies, understand the implications of non-compliance, and enhance your firm's cybersecurity posture to align with SEC guidelines. This session is essential for CCOs, IT professionals, and owners of Investment Advisory Firms.
US Economic Sanctions on Russia: How To Reduce Your Exposure and Be Compliant
Douglas Cohen
60 Min
Product Id: 706906
This webinar will provide you a basic, “Russian Sanctions Compliance Program” for you to implement into your import-export procedures and also closely examine the specific export and financial sanctions against Russia and Belarus, and show you how to reduce your exposure to these new penalties by being compliant.
Risk Management and The New General Chapter, USP<60>, Burkholderia cepacia
Barry A Friedman
90 Min
Product Id: 706907
The Objective of this live, interactive training webinar is to explore the various issues surrounding the history of B. cepacia and its Complex and examine solutions to common microbiological problems. It will discuss the General Chapter USP<60> which was issued December 2019, media that is used, as well as consider recalls, FDA 483s and Warning Letters. The webinar will also review why 16S rRNA identification will not work satisfactorily with this Complex. Please plan to bring an interdisciplinary team to this Webinar to explore how knowledge regarding this contaminant may assist you in your facilities and minimize it as an Objectionable microorganism.
Beneficial Ownership Requirements for a Legal Entity
Doug Keipper
60 Min
Product Id: 706905
This webinar will review the CDD Rule and the new requirements issued by FINCEN, along with sharing information and procedures for the beneficial ownership rule.
Labor Negotiations: Reaching Your Agreement
Bob Oberstein
120 Min
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.
Labor Negotiations: Sharpening Your Negotiation Skill Set
Bob Oberstein
120 Min
Product Id: 706761
This webinar will outline the aspects and uses of "Time," "Information," and "Power" in negotiation, as well as the elements and uses of the different sorts of "Power."
Labor Negotiations: Preparing for Your Negotiation
Bob Oberstein
120 Min
Product Id: 706750
Preparation is mandatory for success, especially at the bargaining table. This first of three segments covers both the big and little things that, with a bit of preparation, can make for a smoother and more successful experience.
The Family & Medical Leave Act, California Family Rights Act & Pregnancy Disability Leave: Managing Employee Leave & Possible Abuse
Diane L Dee
75 Min
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.
Offboarding with Care: Conducting Legal and Ethical Employee Terminations
Diane L Dee
75 Min
Product Id: 706822
If an employer has exhausted all the necessary steps to help the employee improve his or her work performance – and those steps are not working – it may be time to terminate the employee. Terminating an employee is not only stressful for the employee losing a job, but also for the employer. There are legal, ethical steps to take when you terminate an employee. The company must ensure its actions are above reproach. How the company terminates an employee sends a powerful message not only to the terminated employee, but also to remaining staff, either positive or negative.
FDA FSMA Preventive Controls Inspection Hot Buttons for 2022
Gina Reo
60 Min
Product Id: 705949
This course will look at the new FDA direction and other programs aimed at transforming food safety in 2022 and beyond, including how to manage #483 violations for non-compliances.
21 CFR Part 111 - Master Manufacturing Records and Batch Production Records
Andy Swenson
60 Min
Product Id: 706762
The single most critical document in an FDA inspection is the master manufacturing record and associated batch production record. While the 21 CFR Part 111 regulations have a checklist of elements the documents must contain, it can be difficult to translate that into a working document. This training will review the basic principles of what an MMR & BPR must contain and give you tools to create an “FDA Acceptable” document.
Clinical Research Revenue Cycle: Bridging Health Systems and Clinical Research
Mary Veazie
120 Min
Product Id: 706775
Clinical research revenue cycle (CRRC) is an integral part of a clinical research portfolio. It is a complex environment that bridges a health systems revenue cycle with clinical research activities. Health systems involved in clinical research activities struggle with effectively incorporating these two environments. In this course, attendees will learn framework for an effective and compliant CRRC program.
Best Practices for Preparing for an FDA Inspection
Susanne Manz
90 Min
Product Id: 706774
Are you ready for the FDA to knock on your door? Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.
Qualification of Process Analytical Technology (PAT) Based Control Strategies for Batch & Continuous Manufacturing
Michael Levin
60 Min
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.
Federal Oversight of Laboratory-Developed Tests in Limbo: What’s the Regulatory & Legislative Outlook for LDTs?
Dennis Weissman
60 Min
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.
How To Build a Profitable Generic Pipeline Before Your Competition
Peter Wittner
90 Min
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!
Non-conforming Materials and Failure Investigations for Medical Devices
Susanne Manz
90 Min
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.
Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Michael Esposito
90 Min
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.
Feds Take New Aim at Prescription Drug Prices: What to Expect from the Biden Administration & Congress
Dennis Weissman
60 Min
Product Id: 706759
Responding to the public’s ongoing concern about high and rising drug prices, the Biden Administration and 117th Congress with a fragile Democratic majority have unveiled key proposals to lower prescription drug costs.
Biosimilars in Europe: Pricing, Interchangeability and Policy
Peter Wittner
90 Min
Product Id: 706760
As far as biosimilars are concerned, Europe led the way and the rest of the world, including the US, followed - but how did this happen? The webinar will explain how Europe’s EMA developed the first regulatory environment that allowed multiple competitors to enter the market and start to take market share away from the originators. It also looks at the effect of the increased competition, the moves to include biosimilars in tenders, the resultant impact on prices, how the originators fought back and where we are now.