Compliance Training Webinars for Regulated Industries

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.

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.

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.

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.

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.

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.

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.

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.

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?

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.

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.

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.

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.

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.

This Internal Controls for Accounts Payable webinar will provide you with the tools you need to establish and maintain strong internal controls in the A/P department that meet Sarbanes-Oxley standards.

This webinar explores the components of strategic risk. Developing a common understanding and definition of strategic risk helps the participant form a comprehensive base upon which meaningful review and interaction with senior management can occur.

This webinar will review the global regulations pertaining to spices, herbs and their extracts used for flavors as well as an overview of all flavor regulations. It will also go into detail about spice/herb as well as flavor guidance documents from trade organizations, international & regional regulatory bodies and specific country regulations.

This webinar provides some practical and useful answers to the question: “How Large a Sample Do I Need?” Methods for determining appropriate sample sizes in raw materials acceptance, finished product release, process and product development experimentation and process monitoring for process stability and capability is discussed. A comparison is made of the square root (n)+1 sampling rule with the ANSI Z1.4 sampling system for process monitoring including incoming raw materials, in-process manufacturing and finished product. The value of a systems approach to sampling and practical tips, traps and guideline for sampling is discussed. The presentation includes portable methods for making power calculations for experimental design. The concepts and methods involved are introduced and illustrated with pharmaceutical and biotech case studies and examples.

FDA regulates how firms advertise and promote their products in social media. It creates a regulatory risk for enforcement action when firm’s step over FDA’s somewhat mysterious advertising and promotion boundaries. What you or someone else says about your product, whether true, false or misleading, becomes a target for FDA’s legal hammer. FDA can levy fines or issue Warning Letters. Even an injunction or prosecution may end up creating a corporate crisis and confusing your customers and drive them away.