WEBINARS

 

Compliance Training Webinars for Regulated Industries

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European Generic markets - Why do they differ so much?

webinar-speaker   Peter Wittner

webinar-time   60 Min

Product Id: 706049

This webinar provides insights into the European generic market, its regulatory procedures and the impact of the differing national pricing and healthcare environments that have shaped the individual country markets.

Recording Available

 

Managing Corrective Actions: How to stay compliant, stop alienating your workers and prioritize/optimize your efforts

webinar-speaker   Jim loud

webinar-time   90 Min

Product Id: 706398

This webinar is intended to help companies ensure that corrective actions, both regulatory and internally identified, actually fix the problems they address, are appropriately prioritized and are tracked to a timely completion.

Recording Available

 

Designing and Using KPI's and Performance Dashboard

webinar-speaker   Miles Hutchinson

webinar-time   90 Min

Product Id: 703405

This webinar will explain how to design, implement and monitor critical Key Performance Indicators (KPIs) using powerful performance dashboards.

Recording Available

* Per Attendee $199

 

Artificial neural network for chemical engineers

webinar-speaker   Gholamreza Zahedi

webinar-time   60 Min

Product Id: 706343

ANN is the one of the latest solutions that can be used in solving research and development works. The course is specially designed for researchers and engineers who need to use ANN in modelling, parameter estimation, control and optimization.

Recording Available

 

Starting a New Lab for Chemical Analysis

webinar-speaker   James Peterson

webinar-time   60 Min

Product Id: 706306

In this webinar the presenter will draw upon his experience in starting new private, contract research, state and federal government laboratories and laboratory subdivisions to elaborate the numerous aspects of developing a plan to open a new analytical lab for business in a reasonable amount of time.

Recording Available

 

Making Data Driven Decisions using Statistical Hypothesis Testing

webinar-speaker   Steven Wachs

webinar-time   60 Min

Product Id: 704211

This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.

Recording Available

* Per Attendee $299

 

Demystifying the Canadian Drug and Health Products Regulatory Landscape

webinar-speaker   Susanne Picard

webinar-time   60 Min

Product Id: 706209

This seminar will give you a snapshot of what is current, what is coming and what this means to anyone who is currently developing Drugs and other Health Products for the Canadian market. The focus will be on drugs, biologics and medical devices.

Recording Available

 

FDA 21 CFR Part 11 Training: Concept, Compliance and Auditing

webinar-speaker   Angela Bazigos,Don Hurd,Andy Swenson,John E Lincoln

webinar-time   7 Hrs

Product Id: 706435

Recording Available

* Per Attendee $999

 

Using Kanban JIT Systems to Run a Startup Plant

webinar-speaker   Jose Mora

webinar-time   90 Min

Product Id: 700419

Attend this webinar to learn how to set up and use kanbans, JIT, pull system, and drum-buffer-rope in medical device and biotechnology manufacturing start-up operations. Also attendees will learn elements of lean documents and lean configuration, sterilization lot size, MRP II kanban system and how to use kanbans to track off-site sterilization and external supply chain suppliers.

Recording Available

* Per Attendee $299

 

Risky mistakes with Medical Device Compliant Handling -- Challenges in Understanding Compliant Procedures

webinar-speaker   Rita Hoffman

webinar-time   90 Min

Product Id: 706340

The webinar will provide comprehension learning on how to identify and improve your complaint handling process. Learn from an expert the regulations on reviewing, receiving, management criteria for you Complaint Handling Unit. Don’t get caught in being over one-third of firms in 2019 that were issued a 483 and received an FDA Warning Letters citing lack of inadequate complaint handing procedures.

Recording Available

 

The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 705292

This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation in the laboratory.

Recording Available

* Per Attendee $199

 

Mechanisms And Mitigation Strategies For Drug-Induced Liver Injury (DILI)

webinar-speaker   Bryan Norman

webinar-time   90 Min

Product Id: 706341

Drug-Induced Liver Injury (DILI) is one of the most common adverse drug event leading to drug candidate termination and post marketing drug withdrawal. This webinar will describe the known mechanisms associated with DILI and will inform modern methods used to identify and assess risks. Importantly, it will describe mitigation strategies that may be successful in minimizing DILI risks.

Recording Available

 

Training as a Diagnostic? The Hidden Gems of Determining Effectiveness

webinar-speaker   Mike Kent

webinar-time   60 Min

Product Id: 706339

This webinar will illustrate how to use training as a diagnostic tool for improving compliance and efficiency. Learn how to incorporate a few simple yet powerful strategies to help unlock new opportunities for risk reduction, process optimization and improved decision-making. Understand how to collect and then use training data to both advocate for and demonstrate impactful change.

Recording Available

 

NEW Rules for Large Originators/TPS and TPSP - Discover the Impacts and Compliance Requirements

webinar-speaker   Donna K Olheiser

webinar-time   60 Min

Product Id: 705274

Details on the recently approved amendments to the existing ACH security framework and how they affect the TPSP, TPA and Originators. The implementation will take place over a 2-phased process, starting with the largest Originators and TPSP/TPS and ending with large Originators and TPSP/TPS based on volume of ACH transactions. Challenges that may be encountered will be discussed as Originators and TPSP/TPS prepare for this addition to the existing ACH security framework. Included will be the ODFI’s responsibility to ensure the Originator and TPSP/TPS follow this new Rule.

Recording Available

* Per Attendee $229

 

Excel: Power Query - How to Import and Clean Data Quickly

webinar-speaker   Mike Thomas

webinar-time   90 Min

Product Id: 706305

Do you import data into Excel from other sources (such as CSV files, text files, web pages, databases or SharePoint)? Does the data that you import need to be "cleaned" before it can be used? (cleaning refers to things like removing duplicate rows, removing blank rows, removing unnecessary columns, converting case, changing date formats and more).

Do you spend more time than necessary performing data cleaning tasks?

Recording Available

* Per Attendee $249

 

Microbial Issues and its Mitigation in Pharmaceutical Waters

webinar-speaker   Nissan Cohen

webinar-time   60 Min

Product Id: 706368

This webinar is on microbials and their mitigation in pharmaceutical water systems. Microbials, as determined by traditional inoculation and incubation, delineate acceptance or rejection of pharmaceutical water for production and usage. Microbes and bacteria have different states as they develop into biofilms. Mitigation of these single cells or colonies is via sanitization methods. All Pharmaceutical water systems regardless of which pharmacopeia is enforced, must adhere to stringent values of colony forming units (CFUs) per ml.

Recording Available

 

New European Medical Device Regulation (MDR) 2017-745

webinar-speaker   Juan M Campos

webinar-time   60 Min

Product Id: 706302

This webinar will discuss main differences between current EU Medical Device Directive (MDD) 93/42/EEC and new EU Medical Device Regulation (MDR) 2017-745 and how to ensure compliance with the new MDR requirements that will be mandatory starting May-2020.

Recording Available

* Per Attendee $299

 

How Sponsors Generate GCP Noncompliance at Investigator Sites

webinar-speaker   Stephen Schwartz

webinar-time   90 Min

Product Id: 706280

Attend this webinar to explore some of the common sponsor errors. Become aware of the risk and liability of these decisions. Learn how to get approvals of submission, prevent enforcement actions, and loss.

Recording Available

* Per Attendee $299

 

Effective (and FDA Compliant) Management Reviews

webinar-speaker   Larry Stevens

webinar-time   60 Min

Product Id: 705646

So, we perform Management Reviews because FDA regulations require it? In fact, if you are performing management reviews only to satisfy FDA, you may be complying but you are probably wasting your time. Effective management reviews should have tangible value to the senior executives performing the review. In this online training, we will review how to perform effective management reviews that will assist in the effective management of the company.

Recording Available

* Per Attendee $299

 

Process Capability Analysis, and What to Do if it's Not a Bell Curve

webinar-speaker   William Levinson

webinar-time   60 Min

Product Id: 705157

This process capability analysis webinar will discuss the relationship between variation and accuracy, and process yield, short term versus long term variation, non-normal distributions and how to perform a process capability study.

Recording Available

* Per Attendee $229

 

 

 

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