The Nature of e-Banking, a Precursor to Understanding its Compliance & Risks
Richard Barr
90 Min
Product Id: 702358
This 90-minute webinar will introduce you to the components that make up today’s e-Banking services. It is also a precursor, for those unfamiliar with it, to further modules focusing on understanding the risks associated with e-Banking, as well as the compliance challenges we face.
Biomarkers for Drug Development: The Emerging Regulatory Landscape
Orest Hurko
60 Min
Product Id: 702396
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices
David Lim
90 Min
Product Id: 702252
This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner.
Pharmaceutical Water System Use & Monitoring
T.C Soli
90 Min
Product Id: 702265
This webinar on pharmaceutical water systems will explain practical best practices for outlet use and sampling to reflect the true water quality and how to most effectively use the resulting data to improve manufacturing’s water use practices and maintain water system control before problems arise from biofilm-related contamination.
Lockout/Tagout and Machine Guarding: How Small Tweaks to Your Program Can Mean Big Savings in Costs and Injuries
Michael Lawrence
60 Min
Product Id: 702379
This webinar will focus on the key elements of a comprehensive Lockout/Tagout (LOTO) program, the 3 common LOTO trouble areas, the 5 types of machine guards and what to expect in an OSHA inspection of your LOTO program. A real-world 9-step LOTO procedure that works will also be discussed.
Making Sense of FDA's (proposed) Rules for the Development and Approval of Biosimilars
Karl M. Nobert
60 Min
Product Id: 702325
This webinar will help you understand the process, requirements, quality and safety considerations for demonstrating biosimilarity to a Reference Product. You will learn about what type and how much clinical data are needed to support a showing of biosimilarity.
Good Laboratory Practices for Bioanalytical Laboratories
Anne E Maczulak
90 Min
Product Id: 702338
This 90-minute webinar will help you to develop a sound bioanalytical process to ensure quality data. It will cover techniques for bioanalytical data management for the purpose of assuring a regulatory agency that the data have been collected, managed, and archived to the highest standards of quality assurance. You will understand the aspects of bioanalysis that can be run according to GLPs and the aspects in which GLPs do not apply.
The Use and Mis-use of FMEA in Medical Device Risk Management
Dev Raheja
90 Min
Product Id: 702384
This 90-minute webinar will cover the best industry practices for Failure Modes and Effects Analysis (FMEA). You will learn what mistakes to avoid, how to reduce design and manufacturing defects, and how to implement risk management efficiently.
Procure to Pay (P2P) Metrics and Dashboards
Chris Doxey
60 Min
Product Id: 702370
This session will provide a roadmap for the implementation of key metrics that can be used in formulating a P2P Dashboard. Attendees will learn how to actually use metrics and trends to develop areas for business process improvement.
An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials
Mukesh Kumar
90 Min
Product Id: 702308
This webinar will provide you with an overview of risk factors in clinical trials and discuss possible ways to mitigate, control, assess impact, and prevent them in your trial.
Ethics and Scientific Misconduct in Regulated Studies
Anne E Maczulak
60 Min
Product Id: 702343
This webinar discusses the high risks of scientific misconduct in regulated studies. You will understand the main issues in producing study results of the highest integrity, learn how managers can implement a system for ensuring accurate and reliable data, understand the "red flags" of questionable data or reporting and develop a plan for identifying the high-risk steps in your operation.
HIPAA and EHRs: How to Comply with the New Regulations and What to Ask of your Vendor
Jim Sheldon-Dean
90 Min
Product Id: 702258
This 90-minute webinar will review the new and proposed HIPAA Privacy and Security regulations and discuss their effects on the use of Electronic Health Records (EHRs).
Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies
Alfonso Fuller
60 Min
Product Id: 701216
This FDA Inspection training provides concrete strategies for planning remediation projects.
Chemical Safety and Chemical Hygiene Plans for the Lab Environment
Michael Lawrence
60 Min
Product Id: 702372
This webinar will help you understand the key principles of chemical and safety practices within a laboratory environment. It will provide tools to help you build your Chemical Hygiene Plan (CHP) and ensure compliance with OSHA regulations.
Developing and Implementing Golden Parachute Agreements
Michael Melbinger
90 Min
Product Id: 702363
This 90-minute webinar will provide practical tips on how you can develop and implement Golden Parachute Agreements that fulfill tax code and federal securities law requirements, pass investor and media scrutiny, and avoid potentially high stakes litigation.
Changes to Good Pharmacovigilance Practices in the EU
Robert J Russell
90 Min
Product Id: 702341
This 90-minute webinar will provide you a thorough understanding of the updated framework surrounding Good Pharamcovigilance Practices (GVP) in the EU. This will include updates to the EU regulation, Directive and the first seven PV Modules, which have been published for consultation.
HR Policies for Small Companies/Organizations
Joe Gross
90 Min
Product Id: 702331
This 90-minute webinar provide you a comprehensive understanding of HR policies that small companies need to have, information on the number of employees you can have before you must have these policies in place, and save you from penalties and fines.
Full-day Virtual Seminar : Navigating the Japan Regulatory and Clinical Trial Environment; Conducting Clinical Studies in Japan
Robert J Russell
6 hrs
Product Id: 702170
This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.
Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial
Madhavi Diwanji
90 Min
Product Id: 701980
This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.
Risk Management for Human Resources
Marna Hayden
60 Min
Product Id: 701711
This HR Risk Management training will cover compliance "Hot Spots" where HR professionals need to be especially vigilant in times of complex labor laws, changing environments and workforce reorganization.