WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Validation and Use of Cloud Computing in FDA Regulated Environments

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 703423

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

Recording Available

* Per Attendee $249

 

Medical Device Reporting - Current MDR Regulations and Strategies to Implement FDA Final Guidance

webinar-speaker   Rita Hoffman

webinar-time   90 Min

Product Id: 705844

This medical device reporting webinar will guide you to understand best practices to assess your current MDR efforts and implement changes to match the FDA's new guidance recommendations. Attendees will learn the current regulations that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for any device-related adverse events and certain malfunctions (investigational study reporting).

Recording Available

 

Stability Programs for Leachable Impurities

webinar-speaker   Wayland Rushing

webinar-time   60 Min

Product Id: 704685

This training program will closely examine what are extractables and leachables. It will focus on how to design and implement leachable stability programs, including the requirements for leachable stability programs, developing and validating methods for use in leachable stability programs, and drug product impurities vs. leachable impurities.

Recording Available

* Per Attendee $199

 

How Managers Can Erode Toxic Behaviors, Improve Performance and Reduce Workplace Drama!

webinar-speaker   Dr. Mitchell Kusy

webinar-time   60 Min

Product Id: 705846

This webinar will discuss how to identify toxic personalities in work and Toxic buffers and protectors who help toxic people get away with bad behavior, how to change recruiting methodology to restrict hiring toxic personalities, what coaching method to use to rectify toxic personalities and make the workplace safe and respectful. Also it will discuss how to calculate the loss due to toxic people in organization so that it is worth come as prime initiative for top management buy in.

Recording Available

* Per Attendee $199

 

Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 705347

This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.

Recording Available

* Per Attendee $249

 

Process Variation with X-Bar and R Charts

webinar-speaker   Michael Abitz

webinar-time   60 Min

Product Id: 705862

This webinar will teach you how X-Bar and R Charts are used to identify and analyze variation within transactional and manufacturing processes. All Processes in an organizations need to be protected and monitored so monitoring control charts offers Process Owners a way to determine if their processes are in control, capable and stable.

Recording Available

 

Hot Work Permits: All You Need to Know

webinar-speaker   Joe Keenan

webinar-time   90 Min

Product Id: 705779

Avoid fires and burns on the job. Learn how to perform hot work safely and keep your workplace injury-free with new Hot Work Safety Certificate Online Training. Learn hot work evaluation requirements, hot work team roles and responsibilities and how to approach for hot work safety.

Recording Available

 

Verification or Validation of Methods in Food Microbiology

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 705822

This webinar will not only address the semantics, but will also discuss the appropriate analytical and statistical approaches to achieving successful verification and validation studies with respect to food microbiology. The quantitative and qualitative methods of performance measurement will be discussed for verification and validation.

Recording Available

* Per Attendee $229

 

Storage Conditions of Drugs as an Essential Factor for Maintaining Efficacy

webinar-speaker   Mohammad Elnadi

webinar-time   60 Min

Product Id: 705865

In this webinar attendees will learn the guidelines on good storage & distribution practices of pharmaceutical products and the factors affecting the quality of products. Various types of storage conditions & environmental control processes will be discussed to avoid potency loss of drug products while stored in the premises.

Recording Available

 

Construction, Engineering and Scientific Cost Estimating as per OSHA 29 CFR

webinar-speaker   Keith Warwick

webinar-time   75 Min

Product Id: 705162

This training program will break down the essential elements covered under OSHA 29 CFR 1910 and 29 CFR 1926 with respect to construction, engineering and scientific cost estimating. In particular, the webinar will discuss techniques for preparing rough estimates, techniques for evaluating and estimating scientific processes, contingencies, overhead and profit, estimating cost of new construction, estimating costs of environmental remediation, and more.

Recording Available

* Per Attendee $199

 

Volatile Termination – Strategies to avoid Allegations of Wrongful Termination

webinar-speaker   Margie Pacheco Faulk

webinar-time   90 Min

Product Id: 705812

This webinar will discuss the regulations and guidance by EEOC related to termination, how to avoid discrimination or wrongful termination and have termination with dignity and respect. The policies and termination process and documentation steps required.

Recording Available

 

Ensuring Integrity and Security of Laboratory Data

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 702454

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

Recording Available

* Per Attendee $249

 

Fork Lift and Powered Industrial Truck Operator Safety Training

webinar-speaker   John J Meola

webinar-time   90 Min

Product Id: 705611

This webinar will review the OSHA PIT Standard with a focus on training and qualifications of Trainers, and the components of an effective Training Program. This process is not as simple as one would think.

Recording Available

* Per Attendee $199

 

Vicarious Liability when Conducting Disciplinary Actions - Managers Need to Consider

webinar-speaker   Margie Pacheco Faulk

webinar-time   60 Min

Product Id: 705815

This webinar will discuss Vicarious Liability and its implication, how managers can be implicated during disciplinary action due to their behaviors, how employers can train managers to mitigate risk during disciplinary actions and terminations. What part of affirmative defence can help reducing allegations of discriminations.

Recording Available

* Per Attendee $199

 

Data Analysis in QSR - Techniques and Tools to Avoid Warning Letter

webinar-speaker   Daniel O Leary

webinar-time   90 Min

Product Id: 705830

This webinar will help understand data analysis requirements for QSR, the techniques to identify problems, analyze cause and action plan preparation to avoid FDA inspection and MDSAP audits. It will help you understand how to pick right data analysis techniques from ISO/TR 10017:2003 and how to analyze data in excel.

Recording Available

 

Cyber Incident Response Plans: Planning for the Inevitable

webinar-speaker   Rayleen M Pirnie

webinar-time   90 Min

Product Id: 704414

This webinar training analyzes critical components of a Cyber Incident Response Plan and provides recommendations on how to prepare all staff for the inevitable situations. From internal considerations to your external solution providers, get a realistic view of how a cyber-attack can quickly spiral a typical day into complete chaos and cause significant losses without preparation. Attendees will receive a Cyber Incident Response Plan checklist to help their Incident Response Team analyze or develop a Plan.

Recording Available

* Per Attendee $249

 

US Biosimilar Regulations, Barriers and FDA Expectations

webinar-speaker   Peter Wittner

webinar-time   60 Min

Product Id: 705842

This webinar will discuss the history of biosimilar - how EMA led the way and how FDA is catching up. It will give Insight into the varying regulatory approaches prevailing in different regions & overview of the Biosimilars picture across the world, the barriers (known as "The Patent Dance") to entry. It will discuss about interchangeability issues, what proof does FDA require, US biosimilar registrations success and failures and how to avoid failures. Enough background to determine whether entering the biosimilars market is an appropriate strategy for their company.

Recording Available

 

The OSHA Recordkeeping Analysis for Experienced Recordkeepers

webinar-speaker   William Principe

webinar-time   60 Min

Product Id: 705693

This OSHA recordkeeping webinar will discuss the more subtle nuances of recordkeeping, with review of pertinent OSHA Q&As and hypothetical scenarios. The OSHA 300 Log, the conflicting doctor rule, restricted work and significant aggravation.

Recording Available

* Per Attendee $199

 

Auditing and examining Travel and Entertainment Expenses: Expense Reimbursement Fraud

webinar-speaker   Lynn Fountain

webinar-time   90 Min

Product Id: 703767

This training program will address why internal controls over travel and entertainment (T&E) expenditures are a critical component of the control environment. Although the topic of travel and entertainment abuse is not one that management likes to address, it is a very important indicator of the adequacy of a company’s control environment.

Recording Available

* Per Attendee $249

 

Extractables and Leachables in Early Phase Development

webinar-speaker   Wayland Rushing

webinar-time   60 Min

Product Id: 704517

This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.

Recording Available

* Per Attendee $179

 

 

 

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