European Generic markets - Why do they differ so much?
Peter Wittner
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.
Managing Corrective Actions: How to stay compliant, stop alienating your workers and prioritize/optimize your efforts
Jim loud
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.
Designing and Using KPI's and Performance Dashboard
Miles Hutchinson
90 Min
Product Id: 703405
This webinar will explain how to design, implement and monitor critical Key Performance Indicators (KPIs) using powerful performance dashboards.
Artificial neural network for chemical engineers
Gholamreza Zahedi
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.
Starting a New Lab for Chemical Analysis
James Peterson
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.
Making Data Driven Decisions using Statistical Hypothesis Testing
Steven Wachs
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.
Demystifying the Canadian Drug and Health Products Regulatory Landscape
Susanne Picard
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.
FDA 21 CFR Part 11 Training: Concept, Compliance and Auditing
Angela Bazigos,Don Hurd,Andy Swenson,John E Lincoln
7 Hrs
Product Id: 706435
Using Kanban JIT Systems to Run a Startup Plant
Jose Mora
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.
Risky mistakes with Medical Device Compliant Handling -- Challenges in Understanding Compliant Procedures
Rita Hoffman
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.
The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory
John Fetzer
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.
Mechanisms And Mitigation Strategies For Drug-Induced Liver Injury (DILI)
Bryan Norman
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.
Training as a Diagnostic? The Hidden Gems of Determining Effectiveness
Mike Kent
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.
NEW Rules for Large Originators/TPS and TPSP - Discover the Impacts and Compliance Requirements
Donna K Olheiser
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.
Excel: Power Query - How to Import and Clean Data Quickly
Mike Thomas
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?
Microbial Issues and its Mitigation in Pharmaceutical Waters
Nissan Cohen
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.
New European Medical Device Regulation (MDR) 2017-745
Juan M Campos
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.
How Sponsors Generate GCP Noncompliance at Investigator Sites
Stephen Schwartz
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.
Effective (and FDA Compliant) Management Reviews
Larry Stevens
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.
Process Capability Analysis, and What to Do if it's Not a Bell Curve
William Levinson
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.