WEBINARS

 

Compliance Training Webinars for Regulated Industries

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The Nature of e-Banking, a Precursor to Understanding its Compliance & Risks

webinar-speaker   Richard Barr

webinar-time   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.

Recording Available

* Per Attendee $149

 

Biomarkers for Drug Development: The Emerging Regulatory Landscape

webinar-speaker   Orest Hurko

webinar-time   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.

Recording Available

* Per Attendee $229

 

How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices

webinar-speaker   David Lim

webinar-time   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.

Recording Available

* Per Attendee $229

 

Pharmaceutical Water System Use & Monitoring

webinar-speaker   T.C Soli

webinar-time   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.

Recording Available

* Per Attendee $349

 

Lockout/Tagout and Machine Guarding: How Small Tweaks to Your Program Can Mean Big Savings in Costs and Injuries

webinar-speaker   Michael Lawrence

webinar-time   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.

Recording Available

* Per Attendee $149

 

Making Sense of FDA's (proposed) Rules for the Development and Approval of Biosimilars

webinar-speaker   Karl M. Nobert

webinar-time   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.

Recording Available

* Per Attendee $229

 

Good Laboratory Practices for Bioanalytical Laboratories

webinar-speaker   Anne E Maczulak

webinar-time   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.

Recording Available

* Per Attendee $229

 

The Use and Mis-use of FMEA in Medical Device Risk Management

webinar-speaker   Dev Raheja

webinar-time   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.

Recording Available

* Per Attendee $229

 

Procure to Pay (P2P) Metrics and Dashboards

webinar-speaker   Chris Doxey

webinar-time   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.

Recording Available

* Per Attendee $149

 

An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials

webinar-speaker   Mukesh Kumar

webinar-time   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.

Recording Available

* Per Attendee $229

 

Ethics and Scientific Misconduct in Regulated Studies

webinar-speaker   Anne E Maczulak

webinar-time   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.

Recording Available

* Per Attendee $229

 

HIPAA and EHRs: How to Comply with the New Regulations and What to Ask of your Vendor

webinar-speaker   Jim Sheldon-Dean

webinar-time   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).

Recording Available

* Per Attendee $229

 

Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies

webinar-speaker   Alfonso Fuller

webinar-time   60 Min

Product Id: 701216

This FDA Inspection training provides concrete strategies for planning remediation projects.

Recording Available

* Per Attendee $229

 

Chemical Safety and Chemical Hygiene Plans for the Lab Environment

webinar-speaker   Michael Lawrence

webinar-time   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.

Recording Available

* Per Attendee $149

 

Developing and Implementing Golden Parachute Agreements

webinar-speaker   Michael Melbinger

webinar-time   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.

Recording Available

* Per Attendee $149

 

Changes to Good Pharmacovigilance Practices in the EU

webinar-speaker   Robert J Russell

webinar-time   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.

Recording Available

* Per Attendee $229

 

HR Policies for Small Companies/Organizations

webinar-speaker   Joe Gross

webinar-time   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.

Recording Available

* Per Attendee $149

 

Full-day Virtual Seminar : Navigating the Japan Regulatory and Clinical Trial Environment; Conducting Clinical Studies in Japan

webinar-speaker   Robert J Russell

webinar-time   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.

Recording Available

* Per Attendee $1099

 

Clinical Trial Auditing - Identifying risks and building a more compliant and successful trial

webinar-speaker   Madhavi Diwanji

webinar-time   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.

Recording Available

* Per Attendee $229

 

Risk Management for Human Resources

webinar-speaker   Marna Hayden

webinar-time   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.

Recording Available

* Per Attendee $199

 

 

 

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