
Lyophilization Process Development and Cycle Design with a Case Study
J. Jeff Schwegman
90 Min
Product Id: 701961
This webinar on Lyophilization Process Development and Cycle Design will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle.

Strategies to Mitigate Preclinical Safety Risks in Drug Discovery
Bryan Norman
90 Min
Product Id: 706071
This webinar will discuss current best practices in understanding, assessing and mitigating many preclinical safety concerns in drug discovery. It will highlight many of the primary factors impacting drug safety, such as drug properties, target and tissue specificity, metabolic profile and reactive metabolite formation. It will also demonstrate many modern preclinical mitigation strategies and techniques to improve the safety of potential drug candidates.

Wage and Hour Law - California Style for 2019
Vicki M. Lambert
90 Min
Product Id: 703771
This 90 minute California wage and hour compliance training will help you understand the complexities surrounding California wage and hour laws and how it affects the function of any payroll department or company that has employees in California.

Procure-to-Pay Fraud: Detecting and Preventing Purchasing, Receiving and Disbursement Frauds
Peter Goldmann
90 Min
Product Id: 702608
This P2P fraud control webinar will discuss how to prevent procure-to-pay fraud by understanding the red flags in all three stages of purchasing, receiving and disbursements. It will teach you which tools and techniques to use for P2P fraud detection and How to conduct a Fraud Risk Assessment of the P2P Cycle and build effective control framework.

BSA/AML, Case Studies From The Field
Doug Keipper
60 Min
Product Id: 706048
This BSA/AML training is drawn on case studies of the last 15 years. This class will help drive the BSA officers and analysts to consider the who, what, why, where, when and how in their case studies. Most BSA officers and analysts are always curious as to how someone uncovered the activity. Was it a software alert or was it an employee referral? If a software alert, what are the parameters? If it was an employee referral, why did this suddenly get flagged? Attend this course to uncover the hallmark attributes of these case studies.

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics
Norma Skolnik
60 Min
Product Id: 704371
In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.

When and How to Report Errors to Customs and Border Protection
Donna L Shira
60 Min
Product Id: 703292
This U.S. Customs & Border Protection compliance (CBP) training will focus on methods that can be used in reporting the errors to the CBP. Attendees will learn best practices for importing products into the U.S to avoid penalties.

Best Practices for Sexual Harassment Internal Investigations
Mary Gormandy White
60 Min
Product Id: 705672
This sexual harassment investigation webinar will teach how to conduct harassment and bullying investigations. Attendees will learn legal issues of investigations, characteristics of an investigator, report writing, presentation, communication with case studies and examples.

The "New NAFTA": The USMCA
Martin Behr
60 Min
Product Id: 705941
In this trade compliance webinar attendees will learn the benefits, processes, objectives and implementation of "New NAFTA" or "USMCA" agreement. It will cover the biggest changes in agricultural, manufactured products, labor conditions, digital trades area and how to qualify your products, certifications, and filings.

Medical Device Software per IEC 62304
Jose Mora
60 Min
Product Id: 706057
You may find out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant. Don’t let that happen. This webinar will teach you how to submit compliant and adequate software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. Also, learn how to avoid the potential audit risk which might prevent you from selling the approved product if you have been found to not have an IEC62304 Compliant Software Quality System.

Advanced Interviewing - A Talent-Focused Approach to Successful Recruitment and Selection
Tony Miller
60 Min
Product Id: 705678
This advanced interviewing techniques webinar will teach how to recruit high quality resources through 9 step process to decrease cost, turnover and increase output.

USA Export Documentation and Procedures
Jan Seal
90 Min
Product Id: 705536
This webinar will assist U.S. companies who export goods around the world to understand the Bureau of Industry and Security U.S. export procedures and regulations and the Foreign Trade Regulations for reporting electronic export information in the Automated Export System (AES) to U.S. Census. It will also assist companies in implementing or updating written export procedures and implementing internal controls to reduce or avoid penalties.

Secure Medical Device Procurement
Nick Sikorski,Phil Englert
60 Min
Product Id: 706003
This Medical Device Security webinar will focus on industry leading practices to assist healthcare delivery organizations (HDOs) with the integration of security into medical device procurement to inform procurement decisions, contractual requirements, and compensating controls. Also attendees will learn the required steps involved in the procurement process, some of which include vendor-level and product-level assessments, contractual requirements, and publicly available resources to assist with standardization.

New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines
Gregory Martin
90 Min
Product Id: 705733
This webinar will discuss the new elemental impurities test requirements as per the new ICH Q3D and USP 232/233 Guidelines, the testing required to comply with it and how to do proper risk assessment and analytical measurements, which drug products are within the scope, the documentation related to control of elemental impurity, which methods required to be validated.

Toxic Impurities in Active Pharmaceutical Ingredients
Loren Gelber
75 Min
Product Id: 706056
The recent recalls of sartan antihypertensives due to the presence of nitrosamines may suggest increased attention from FDA to toxic impurities in drug products from active pharmaceutical ingredients. The public information about the limits of toxic impurities and about nitrosamines in sartans will be discussed and possible similar situations reviewed in this webinar.

How to Manage Risk in the Supplier Onboarding Process With Best Practices for Your Supplier Management Lifecycle
Chris Doxey
90 Min
Product Id: 706038
Attend this webinar to learn the best practices for supplier management that will facilitate compliance through the supplier management lifecycle and can help you to manage risk. Also attendees will learn the technology solutions focus on solving supplier management problems, supplier master fraud indicators and compliance requirements for supplier master.

Documentation of Medical Necessity - Focus for OIG and other auditors
Laura S Hargraves
60 Min
Product Id: 705139
This medical necessity documentation webinar will cover all the key information needed to support your efforts to document and demonstrate Medical Necessity of services.

Impact of Ethics on Leadership
Lynn Fountain
90 Min
Product Id: 706030
In this webinar attendees will learn the impact of ethical and questionable leadership behavior in an organization and its control environment. We will examine some of the past decade's “questionable” leaders when it comes to the topic of ethics. Also attendees will learn how to identify actions that can be taken by leaders to improve ethics and the control environment at their company.

Texting and Mobile Devices in Healthcare - HIPAA and CMS Requirements for Security of PHI
Jim Sheldon-Dean
90 Min
Product Id: 705623
The webinar will discuss the requirements, the risks, and the issues of the increasing use of mobile devices and texting for patient and provider communications and provide a road map for how to use them safely and effectively, to increase the quality of health care and patient satisfaction. In addition, the session will discuss how to be prepared for the eventuality that there is a breach, so that compliance can be assured.

How to Conduct an Internal Audit to Avoid an External One
Vicki M. Lambert
90 Min
Product Id: 703353
Attend this webinar to learn the strategies for conducting an internal audit and discover whether or not you have been subject to fraud plus help you to prevent internal fraud in the future. It will provide best practices for payroll departments to avoid external audits.