What Should You Do If An Applicant Has A Criminal History?
Margie Pacheco Faulk
90 Min
Product Id: 705829
This training will provide an effective process on how to handle criminal background screening whether you are in a ban the box state with strict regulations or is you follow the Equal Employment Opportunity Commission (EEOC) guidance on how to avoid discrimination when rejecting an employee with criminal background convictions.
Self-certified 510(k) Clearance for Devices
Casper Uldriks
60 Min
Product Id: 706356
Firms must develop criteria to determine whether they meet FDA’s qualification requirements to participate in this expedited 510(k) clearance process. This program requires a firm to develop and implement a rigorous initial and ongoing quality assurance program. Attend this webinar to learn how to.
How to Conduct a Simulated OSHA Inspection - Safety & Industrial Hygiene
John J Meola
90 Min
Product Id: 706350
Attend this webinar the principal elements that an OSHA Compliance Officer will look for during an inspection. Most of these elements are functional, operational, physical, such as machine guards, fire extinguishers, safety gear, PPE, etc. OSHA’s required ‘written programs’ in key safety disciplines, such as PPE, Lock Out-Tag Out; Silica Dust; Respirators; Hazard Communication/Globally Harmonized Standard; etc. will be discussed. It will explore the administrative side to the simulated inspection, such as your organization’s written safety & health program.
Understanding and avoiding safety risks associated with Toxicophores and Structure Alerts
Bryan Norman
60 Min
Product Id: 706327
Structure Alerts, also known as toxicophores, are classes of chemicals, functional groups or substructures that, when present in drugs or drug candidates, have been linked to preclinical toxicity and/or adverse drug reactions in humans. This webinar will define and describe many of those structure alerts and outline the mechanisms that have been associated with their toxicity. Mitigation strategies will also be discussed.
How low can you go? Different ways to determine the limit of detection
James Peterson
60 Min
Product Id: 706251
This webinar will present and apply FBI, FDA and EPA approved methods for the determination of limits of detection (LOD) and limits of quantitation (LOQ) in chemical forensic and environmental analysis. These methods apply to most analytical techniques including gas and liquid chromatography, mass spectrometry, and elemental and molecular spectroscopy and can be used when analyzing blood, urine, food, or trace evidence for the presence of toxic chemicals or drugs.
Comparison Between the EU and FDA Regulatory Protocols
George Yanulis
90 Min
Product Id: 706297
This webinar compares the EU and FDA regulatory protocols to help individuals involved in manufacturing, customer service, quality assurance roles to streamline their understanding of the rapid and ongoing regulatory changes being adopted by all medical device regulatory bodies where manufacturers sell and manufacture their devices.
Hospital Case Management Rules and Regulations: Doing it Right
Bev Cunningham
60 Min
Product Id: 706136
This webinar will review the compliance issues that most greatly impact on your practice such as the 2-midnight rule, the NOTICE Act, HINNs, and many others. It will help you to identify where you may have compliance practice gaps as well as how to fix them.
Japan's Medical Device Approval Process
John Riggi
60 Min
Product Id: 706293
This webinar will discuss the basics of product registration in Japan such as Registration Timelines, documentation requirements and governmental processes.
US FDA, Canada Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW - MDSAP & EU ISO 13485 approach
Juan M Campos
60 Min
Product Id: 706301
This webinar will discuss the main regulatory regimes for medical devices in US, Canada, Brazil, Japan and Australia, how they differ from EU CE mark regulations and how to address compliance though a Medical Device Single Audit Program (MDSAP) and ISO 13486:2016 approach.
Stress-Testing in Financial Institutions: Selecting Appropriate Scenarios
Fred Vacelet
60 Min
Product Id: 705249
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.
Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry
Robert J Russell
90 Min
Product Id: 702038
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.
Compliance Requirements for Unauthorized Returns with recently Approved Changes to the Rules
Donna K Olheiser
60 Min
Product Id: 705282
In this 60-minute session, the trainer will cover all the recently approved changes and details for returning an unauthorized transaction, including when to use a R10 or an R11 Return Reason Code. Examples used throughout the session will outline these changes, describe their effect on you as a participant in the ACH network, whether you are an RDFI or an ODFI.
ISO 14001, ISO 50001 and the Bottom Line
William Levinson
60 Min
Product Id: 706310
ISO 14001 and ISO 50001 are related standards for environmental and energy management systems, whose implementation can deliver substantial bottom line financial results for their users. What relates them is the fact that material and energy that enter a process must come out either as a saleable product or waste, and elimination of waste flows directly to the bottom line and this webinar will provide simple analytical tools with which to achieve this.
Analyzing IFRS Financial Statements - What’s the Difference?
Mike Morley
60 Min
Product Id: 704558
This training program will answer questions related to IFRS financial statements and compare them to GAAP based statements using numbers from examples that come from every-day life. The course will also analyze the four key principles of IFRS and the cash flow statement, and discuss using financial statement notes to decode the numbers.
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
Charity Ogunsanya
90 Min
Product Id: 703885
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.
6-Hour Virtual Seminar: Death by CAPA - Does your CAPA Program need a CAPA?
Susanne Manz
6 Hrs
Product Id: 706270
This 6-hour virtual seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You’ll gain insights into the regulatory expectations, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance.
Finding and evaluating branded and generic biopharmaceutical market entry opportunities
Yali Friedman
120 Min
Product Id: 706331
This webinar distills learnings from more than 20 years spend providing guidance to biopharmaceutical companies and related stakeholders. You will learn how to find and evaluate branded and generic entry opportunities, how to anticipate changes in demand for drugs, and how to add value to your partnerships.
Practical Fundamentals for an Effective and Efficient On-the-Job Training Program
Mike Kent
90 Min
Product Id: 706324
This webinar will identify elements critical to both the compliance and effectiveness of an On-the-Job Training (OJT) program and provide practical strategies for implementing them efficiently and sustainably. Whether your training program is just getting started or is highly mature, the tools and ideas presented here will help you optimize its effectiveness while reducing compliance risk.
Identifying and Managing Emerging Operational Risks
Daniel Clark
60 Min
Product Id: 705588
This webinar will instruct participants on how to best recognize and understand operational risks, emerging trends, and how to establish great risk management techniques over this risk area.
Technical Writing for Medical Devices
Joy McElroy
120 Min
Product Id: 706379
This technical writing training program will offer attendees an understanding of how the reporting process supports products in the medical device industry. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.