Compliance Training Webinars for Regulated Industries

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.

This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS). It will focus on key elements of validation including injector, column, detection system, data system and much more.

This webinar training on stress testing in financial institutions will depict scenarios, pitfalls to be avoided, and discuss how the choice of the right scenarios can provide good insight into strategic management of a financial institution.

The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.

This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.

This training program will discuss the four classification of exempt employees permitted under the IRS code including executive, administrative, professional and outside sales. It will examine the salary level test and the salary basis test.

This session will explain how a hospital medical staff should deal with the practitioner who is disruptive of hospital operations. It will discuss disruptive practitioner policies a hospital should have in place and practical tips to correct or terminate the disruptive activity.

This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.

This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.

This training program will detail what just happened with the adoption of the new Same Day ACH Rule and what will it do for the ACH payments network. It will also help identify the impact on financial institutions (ODFIs and RDFIs), including their originators.

This webinar undertakes to explain the process of internal harassment and bullying investigation. Participants will learn how to handle harassment complaints and conduct the investigation to determine facts and minimize liability by analysing evidences, drawing conclusions, writing the formal report outlining the investigation and taking corrective actions where necessary.

This export requirement training will explain the current procedures and documentation requirements for U.S. exports to Mexico and for imports into Mexico, how to avoid delays, cross-border trucking, mandatory labeling requirements, Mexico's Harmonized Tariff Schedule, and recordkeeping requirements.

This training program will discuss in details the new requirements of ISO/IEC 17015:2017 laboratory accreditation standard and their impact on quality management system. It will provide you with an overview of the salient differences and similarities between the old and the new standard and provide advice on what you must do to meet the requirements each of the elements.

In this training program, participants will learn how and why the generations differ in terms of how they approach work - focused on understanding the unique perspectives, contributions and value of each generation. Supervisors will also learn practical best practice tips and suggestions they can apply to effectively manage employees outside their own generation - both older and younger.

This U.S. Export Administration Regulations webinar training will give attendees the tools to assess potential gaps in your company’s export controls/compliance program

The webinar will cover the federal regulatory approach to regulating laboratory-developed tests including the role of CLIA, the rationale for and opposition to direct FDA oversight, the goal of possible federal legislation and the prospects for future action by the FDA and/or Congress.

If you are a federal contractor, having a firm grasp on the essentials of affirmative action and OFCCP compliance is a must, whether you are new to the federal contracting world or a seasoned contractor. This webinar training program will offer attendees an understanding of affirmative action laws and regulations enforced by the OFCCP. It will also discuss Affirmative Action Plans for women and minorities, and for disabled and veteran workers.

This webinar will help you learn how to validate bioanalytical methods. This session will teach you the pitfalls behind bioanalytical methods validation, allowing one to transition between assays with ease.