WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Validation Sampling Plans

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706332

This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.

Recording Available

* Per Attendee $229

 

Nacha New Rule on Meaningful Modernization – All the Details

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 706779

Recent updates to the Nacha Operating Rules were developed to enhance the ACH “user” experience with improvements and simplification by adopting new technologies and channels for the authorization and initiation of ACH payments. Included in the change was a reduction to the barriers when using the ACH Network by providing clarity and increasing consistency pertaining to certain ACH authorization processes and by reducing some of the administrative burdens related to ACH authorizations. What does all this mean will be covered in this 90-minute webinar, explaining how this new Rule applies (and it is optional for Originator/ODFI).

Recording Available

* Per Attendee $249

 

Compliance with the American with Disabilities Act (ADA): What Employers Need to Know in 2022

webinar-speaker   Diane L Dee

webinar-time   90 Min

Product Id: 705608

This webinar will provide participants with a comprehensive understanding of the Americans with Disabilities Act and will explain the importance of compliance and the consequences of non-compliance. Participants will gain a solid understanding of the ADA’s disability accommodation process and the interactions between Federal and State laws.

Recording Available

* Per Attendee $229

 

How to Prepare and Survive an EPA Audit

webinar-speaker   Joe Keenan

webinar-time   60 Min

Product Id: 706857

In this training program attendees will learn the key elements needed to develop a proactive Regulatory Compliance Written Program. After this webinar, you will have confidence in facing the next EPA regulatory compliance audit that comes your way.

Recording Available

* Per Attendee $199

 

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701432

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.

Recording Available

* Per Attendee $299

 

EPA Tier II Reporting

webinar-speaker   Joe Keenan

webinar-time   90 Min

Product Id: 705125

This training program will enumerate the requirements of the Emergency Planning and Community Right-to-Know Act (EPCRA) as it applies to your organization. It will also help attendees understand the threshold trigger for reporting a hazardous chemical on the Tier II forms and learn how to accurately calculate chemical mixtures as it applies to the Tier II forms. Further, attendees will learn to navigate the complexities of online Tier II reporting.

Recording Available

* Per Attendee $179

 

Powerful Closed-loop CAPA - Meeting FDA Expectations

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 702012

This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.

Recording Available

* Per Attendee $299

 

Non-Resident Importer in Canada: Responsibilities, Rights, Benefits and More

webinar-speaker   Fabiola Ferrusquia

webinar-time   60 Min

Product Id: 705463

This webinar will discuss the process of becoming a Canadian Non Resident Importer. Attendees will learn how to attain business registration number, HS tariff classification and tariff treatment, process of claiming GST on imported goods, ways to complete the Canada customs invoice and more.

Recording Available

* Per Attendee $229

 

Being Prepared for an Active Shooter Incident at Workplace

webinar-speaker   Michael Aust

webinar-time   60 Min

Product Id: 704652

This training program will take attendees through the actions to take when confronted with an active shooter and in assisting responding law enforcement officials. It will help recognize potential workplace violence indicators and describe actions to take to prevent and explore the General Duty Clause of the OSH Act.

Recording Available

* Per Attendee $199

 

Project Management for FDA-Regulated Companies

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701758

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

Recording Available

* Per Attendee $299

 

How to Prepare for and Conduct a Regulatory Audit

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706849

In this Regulatory Audit training participants will gain an understanding of how to prepare for and audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as a result of the Covid-19 Pandemic.

Recording Available

* Per Attendee $299

 

FDA Ambitious Regulation of Social Media and Corporate Responsibility

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

Recording Available

* Per Attendee $249

 

The New OSHA Recordkeeping and Reporting Requirements-300, 300A, 301

webinar-speaker   Michael Aust

webinar-time   60 Min

Product Id: 704465

This webinar training will discuss the recent updates in OSHA Recordkeeping and Reporting Requirements. Speaker will explain the major regulatory changes that went into effect January 1, 2015 Participants will gain valuable understanding of 300, 300A and 301 log, new reporting timeline requirements and exemptions.

Recording Available

* Per Attendee $249

 

Wage & Hour Laws: Ensuring Compliance with the Fair Labor Standards Act in 2022

webinar-speaker   Diane L Dee

webinar-time   75 Min

Product Id: 706747

This webinar will lay the groundwork for determining whether your employees are properly classified as Exempt or Non-exempt and ensuring that wage and hour laws are being followed properly.

Recording Available

* Per Attendee $249

 

HIPAA Audit and Enforcement Update for 2022 - HHS Keeps Pressure on Access, Privacy, and Security Compliance

webinar-speaker   Jim Sheldon-Dean

webinar-time   90 Min

Product Id: 705026

This webinar will discuss HIPAA audit and enforcement regulations and processes for 2022 and how they apply to covered entities and business associates. Attendees will learn how to prepare for HIPAA audit to avoid fines and penalties for HIPAA violations.

Recording Available

* Per Attendee $249

 

Major CGMP Issues - US FDA Concerns in 2022

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 702185

This webinar will evaluate the chief areas of FDA CGMP and EU compliance inspections to see actual and anticipated changes in emphasis, and how to better prepare with a company's proactive internal inspection / audit program.

Recording Available

* Per Attendee $299

 

User / Human Factors Engineering Under IEC 62366-1, -2

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 705111

This webinar will focus on the Key parts of IEC 62366-1:2015 and -2:2016, Human Factors Engineering and Role in Design Control (21 CFR 820.30)l, Design and Development Planning (ISO 13485 7.3) .

Recording Available

* Per Attendee $299

 

Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706121

This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create new required reports for the Notified Body and the Competent Authorities and how this process is connected to other processes in the quality management system according EN ISO 13485:2021.

Recording Available

* Per Attendee $299

 

Harmonized Tariff Schedule Classification

webinar-speaker   Jan Seal

webinar-time   90 Min

Product Id: 705224

In this webinar attendees will understand the rules that are required to classify products in the Harmonized Tariff Schedule. Minimize errors in classification and better prepare your company for import/export audits from the government. It will also assist companies who are eligible for free trade agreements, ex. USMCA, and other agreements, in properly completing Certificates of Origin.

Recording Available

* Per Attendee $179

 

CMS Two Midnight Rule

webinar-speaker   Laura Ostrowsky

webinar-time   90 Min

Product Id: 705995

The 2 midnight rule is designed to identify the appropriate level of care for short term stays or episodes in acute care, critical access and long term hospitals and to reimburse accordingly. The rule designed to save money by payment through Medicare part B instead of A is seen by many consumers and providers as both unclear and a cost shift from CMS to consumers and providers hence the controversy surrounding this rule. The presentation will provide history, explanation of the rule with both medical and financial outcomes and illustrate with case examples.

Recording Available

* Per Attendee $299

 

 

 

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