WEBINARS

 

Compliance Training Webinars for Regulated Industries

Metrics and Management for a Suitable and Effective QMS

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706489

In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System (QMS). Management requires suitable metrics presented in Management Review to understand, monitor, and improve the health of the Quality Management System. It is critical that management establishes a quality policy, quality objectives, and provides adequate resources. However, management often fails to realize the importance of their role with respect to quality. In this course, we will discuss how to improve awareness, focus, and a culture of quality. We will discuss how you can keep management aware and informed. We will discuss “red flags” or warning signs of problems.

Recording Available

* Per Attendee $399

 

Recording Available

* Per Attendee $1299

 

Exploring the Impact of CPRA on Organizations

webinar-speaker   Robert Davis

webinar-time   60 Min

Product Id: 706738

The California Privacy Rights Act (CPRA), taking effect on January 1, 2023, will reset best practices for data privacy and protection of business to consumer online transactions. Preparing for CPRA is no small task. In addition to enabling substantial civil penalties and statutory damages, enactment of CPRA has propelled data privacy and protection as business risks directly into the boardroom. Join us for this webinar to accelerate your CPRA readiness, improve your risk management strategies, and prepare for fulfilling your CPRA obligations.

Recording Available

 

Travel and Expense Policy Development and Automation

webinar-speaker   Brian G Rosenberg

webinar-time   60 Min

Product Id: 704880

In this webinar training, you will learn how to create, maintain, and enforce a T&E policy for your organization. The Instructors will discuss the key components and best practices for policies.

Recording Available

* Per Attendee $229

 

Compliance Measures for Case Managers

webinar-speaker   Toni Cesta

webinar-time   60 Min

Product Id: 705318

This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important message from Medicare and others. The Joint Commission is now monitoring these issues when they have deemed status from Medicare, so your compliance is critical to a good Joint Commission survey outcome. This program will help you to identify where you may have compliance practice gaps as well as how to fix them.

Recording Available

* Per Attendee $229

 

Measurement Uncertainty in Microbiology

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 703902

This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.

Recording Available

* Per Attendee $249

 

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704531

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the 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.

Recording Available

* Per Attendee $349

 

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704314

This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.

Recording Available

* Per Attendee $299

 

INCOTERMS - International Commercial Terms

webinar-speaker   John Dunlop

webinar-time   60 Min

Product Id: 702213

This 60-minute webinar will help exporters understand International Commercial Terms, or INCOTERMs, published by the International Chamber of Commerce and how to select the correct one for their transactions.

Recording Available

* Per Attendee $229

 

Handling OOS Test Results and Completing Robust Investigations

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 704351

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.

Recording Available

* Per Attendee $299

 

ICD-10-CM Coding Update FY2022

webinar-speaker   Gloryanne Bryant

webinar-time   60 Min

Product Id: 706610

The purpose of this webinar is to provide a high-level review of the Official Guidelines for Coding and Reporting FY2022 (General Guideline Changes and Chapter Specific Guidelines) to prepare for a new fiscal year of coding changes and meeting compliance, which begins on October 1, 2021. Also, we will present critical instruction on the new ICD-10-CM codes for FY2022 useful for medical practices and facilities for correct billing and reimbursement. There are 159 new codes, 25 deletions, and 27 changes! We'll go over some case studies to analyze and code with ICD-10-CM, which will help you improve your knowledge and skills.

Recording Available

 

Software Design Controls in Life Sciences Applications

webinar-speaker   Eric Henry

webinar-time   4 Hrs

Product Id: 706736

This webinar will discuss the latest global medical device design controls requirements for software in a medical device (SiMD) and software as a medical device (SaMD). Each requirement pulled from U.S. and global standards and guidance (e.g. IEC 62304, IEC 82304, IMDRF SaMD Guidance, AAMI TIR45) will be explored to fashion a complete picture of activities, document content, and dependencies across a variety of lifecycle development models. The session will also include special topics such as evolving cybersecurity requirements, the relationship of software design controls to non-medical device applications, and proposed regulatory frameworks for AI/ML systems.

Recording Available

* Per Attendee $599

 

Best Practices for an Effective Cleaning Validation Program

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 704329

This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.

Recording Available

* Per Attendee $299

 

Verification vs Validation in Regulated Industries

webinar-speaker   John Chapman

webinar-time   60 Min

Product Id: 706734

The meanings and regulatory requirements of the terms “verification” and “validation” are often confusing to engineers and even some regulatory professionals. FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards. The terms apply to design control, process control and others. This presentation will define and explain the differences (& similarities) in these terms and how they apply to regulated industries as well as the consequences of poor adherence.

Recording Available

* Per Attendee $299

 

FMLA Step by Step Compliance

webinar-speaker   Bob Oberstein

webinar-time   90 Min

Product Id: 706735

Although the Family Medical leave Act (FMLA)was enacted 18 years (1993) ago the workplace still has problems complying with its requirements. Sometimes that required compliance is ignored because either the employer or the employee is not aware of their obligations, rights, or both. This webinar is designed to make that compliance easier to understand regardless of if it is a first line supervisor, manager or leave/benefits administrator or the employee.

Recording Available

 

Conducting Discrimination Investigations

webinar-speaker   Melveen Stevenson

webinar-time   60 Min

Product Id: 706733

Discrimination continues to be a problem in the workplace even with existing and developing regulations to train employees and managers against engaging in such behavior. The obligation to conduct a sound and thorough investigation by an appropriate investigator is mostly understood, but practitioners need to do that actual work. This course is designed to provide HR practitioners of all levels with a step-by-step process for conducting discrimination investigations in the work environment that will protect employees and the company as well.

Recording Available

* Per Attendee $229

 

Risk Management Under ISO 14971

webinar-speaker   Don Hurd

webinar-time   60 Min

Product Id: 706732

ISO 14971:2019 is the definitive standard for risk management for medical devices and IVDs. The standard lays out a comprehensive approach to managing risks in the life sciences. The course will discuss practical approaches to complying with the standard.

Recording Available

* Per Attendee $299

 

How to Survive a DEA Inspection Series: Controlled Substances and Hospital Pharmacy

webinar-speaker   Carlos M Aquino

webinar-time   120 Min

Product Id: 701991

This training will cover several recommendations to improve the hospital’s due diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.

Recording Available

* Per Attendee $349

 

Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 705972

This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

Recording Available

* Per Attendee $299

 

Requirements for Running Clinical Trials in Pediatrics for the EU

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 701983

This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.

Recording Available

* Per Attendee $299

 

 

 

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