WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Site Preparation Strategy and Successful FDA Inspection

webinar-speaker   Yasamin Ameri

webinar-time   60 Min

Product Id: 703441

This webinar will explain the Good Manufacturing Practices (GMP) requirements. Attendees will learn strategies for site preparation and hosting of an inspection.

Recording Available

* Per Attendee $229

 

Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application

webinar-speaker   Cheryl Wagoner

webinar-time   60 Min

Product Id: 703438

This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.

Recording Available

* Per Attendee $229

 

Data Management SOPs

webinar-speaker   Adam Ruskin

webinar-time   60 Min

Product Id: 703376

This webinar will teach attendees how to develop more efficient data management SOPs for their company, whether they perform these tasks in-house, oversee this task that a vendor provides, or outsource this task in its entirety.

Recording Available

* Per Attendee $50

 

Fundamentals of SBA Lending: Documenting, Closing, and Funding the SBA Loan

webinar-speaker   Vincent DiCara

webinar-time   90 Min

Product Id: 703462

This webinar will explain the fundamentals of SBA lending and the two most used and popular SBA’s programs: the SBA 504 Program and the SBA 7a Program. Attendees will learn how to document SBA loans, as well as closing and funding SBA loans.

Recording Available

* Per Attendee $149

 

Current FMLA and ADA Issues for Managers

webinar-speaker   Max Muller

webinar-time   60 Min

Product Id: 703429

This webinar will address current HR issues regarding the FMLA and ADA. It will discuss the common mistakes that managers make when applying these laws and how to avoid them.

Recording Available

* Per Attendee $149

 

Equipment Requalification: What and When it is Really Required?

webinar-speaker   Jennifer Medlar

webinar-time   60 Min

Product Id: 703450

This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.

Recording Available

* Per Attendee $229

 

Foreign Corrupt Practices Act - Critical Issues and Best Practices

webinar-speaker   Andrea Ewart

webinar-time   90 Min

Product Id: 703167

This training on the Foreign Corrupt Practices Act will focus on the anti-bribery and accounting provisions of the FCPA and will explain the activities and conducts that are prohibited by the FCPA. Learn the best practices and strategies for avoiding criminal and administrative penalties for violating its provisions.

Recording Available

* Per Attendee $149

 

Issues - Terminations and Exits - Legal Compliance

webinar-speaker   Diana Chomichuk

webinar-time   60 Min

Product Id: 703428

This webinar will explain how to manage employee terminations and exits. Attendees will gain understanding and discover recommended best practices and techniques for ensuring compliance, fairness, and reasonable support during sensitive employee terminations and exits.

Recording Available

* Per Attendee $149

 

FAA Procedures for Transportation Workplace Drug and Alcohol Testing Programs

webinar-speaker   Butch Wilson

webinar-time   60 Min

Product Id: 703456

This webinar will discuss the required procedures for conducting workplace drug and alcohol testing for the federally regulated transportation industry. Attendees will learn how to ensure compliance with the FAA's Drug and Alcohol Testing Regulation.

Recording Available

* Per Attendee $149

 

Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers

webinar-speaker   Les Schnoll

webinar-time   90 Min

Product Id: 703433

This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.

Recording Available

* Per Attendee $50

 

Quality Systems Approach for Validation and Maintenance of a Global ERP System

webinar-speaker   James Carron

webinar-time   90 Min

Product Id: 703424

This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.

Recording Available

* Per Attendee $50

 

COSO 2013 Framework vs. ERM Framework: Implementation Challenges and Opportunities

webinar-speaker   Sonia Luna

webinar-time   90 Min

Product Id: 703415

This webinar will explain similarities and differences between COSO v ERM frameworks. Attendees will understand key advantages of using the ERM framework over the updated COSO 2013 model.

Recording Available

* Per Attendee $149

 

Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs

webinar-speaker   Mukesh Kumar

webinar-time   90 Min

Product Id: 703422

This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.

Recording Available

* Per Attendee $229

 

Effective Coaching for Sustainable Peak Performance

webinar-speaker   Gail Birks

webinar-time   60 Min

Product Id: 703425

This webinar will help you enhance your current strategies of coaching employees & teams for sustainable peak performance. You will be given that are designed for effective coaching, defining roles, measuring performance & implementing plans.

Recording Available

* Per Attendee $50

 

The New European Union Clinical Trials Regulation: An Analysis of the Key Changes and their Implications for Future Clinical Trials

webinar-speaker   Ciara Farrell,Elisabethann Wright

webinar-time   60 Min

Product Id: 703445

This webinar will review the changes introduced by the new European Union ("EU") Clinical Trials Regulation and the implications for future clinical trials.

Recording Available

* Per Attendee $229

 

OSHA Refresher Course - Electrical Safety Compliance

webinar-speaker   Leo Muckerheide

webinar-time   90 Min

Product Id: 702424

This webinar will help you understand the applicable electrical safety practices in the workplace and review the responsibilities and requirements for a person qualified in the OSHA and National Fire Protection Association’s (NFPA) standards.

Recording Available

* Per Attendee $50

 

LDT including CDx; CLIA versus FDA's Authority

webinar-speaker   Abdel Halim

webinar-time   60 Min

Product Id: 703399

This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.

Recording Available

* Per Attendee $229

 

How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 703160

This webinar will help attendees understand how to respond to inspection and audit findings using CAPA (Correction and Preventative Action) for all types of GXP inspections and audit (eg GCP, GLP, GMP, GPV).

Recording Available

* Per Attendee $229

 

Business Associate Agreements (BAA): Why the Pushback from Business Associates

webinar-speaker   Tom Dumez

webinar-time   60 Min

Product Id: 703397

This webinar will explain the requirements of the Omnibus Final Rule regarding Business Associate Agreements (BAA’s) including what it was, what it is now, and what it might be in the future. It will discuss responsibility, liability, indemnification, injunctive relief, and other topics that are causing, or may be causing, contention.

Recording Available

* Per Attendee $229

 

Understanding OSHA - Avoiding Citations and Preparing for the Unexpected

webinar-speaker   Paul Gogulski PE

webinar-time   90 Min

Product Id: 703419

This webinar will explain how to prepare for an unannounced OSHA inspection and avoid citations and fines. Attendees will learn how to effectively use Job Hazard Analysis (JHA) to prevent accidents in the workplace.

Recording Available

* Per Attendee $50

 

 

 

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