Risk Management and Compliance Functions
The presentation will be prefaced by a review of the risk consequences that risk management and compliance functions are intended to prevent or at least, modify.This follows with a review of how risk management and compliance functions differ and then interrelate.Firstly, the presentation examines the roles and responsibilities of the compliance function. Specifically, it focuses on the function being respo..
Adaptive S & OP
Companies are facing an ever more increasingly complex environment coupled with increasing marketplace volatility. This is causing companies to strive to be more flexible and responsive by streamlining both planning and execution. In addition, companies are attempting to conserve the use of their valuable resources. Instead of investing in products prematurely that then creates an inventory that may not be ..
Artificial Intelligence and the Law
In this practical webinar, you will learn about the latest developments in Artificial Intelligence and get a glimpse into the future, as additional legal tasks get automated.Upon course completion, you will be able to:Define “machine learning”Describe how machine learning is already being used by law firmsEvaluate how Artificial Intelligence is changing legal jobsConsider the ethical implications of Artific..
Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.One of the requirements for such compliance is the g..
Audit2020: Evolving the Internal Audit Process
The internal audit profession is very similar to other professions; very resistant to change. When one of our profession’s main goals is to promote efficiency and effectiveness, we have to be more adept at adjusting and being open-minded to change. Audit2020 is a course that takes an in-depth look at the accepted practices inherent in internal audit and critically analyses each piece, identifying ways to en..
Auditing Business Continuity Plans According to ISO 22301
Successful business continuity planningInvolves the entire organization Requires clear and consistent communication Encompasses how employees will communicate, where they will go, and how they will keep doing their jobsPrepares the organization for disruptive eventsWhy is BCP Important? 61% of companies surveyed had to invoke their BCP 43% had to invoke it more than onceKey Causes: Natural Disaster, Power O..
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
Analysis of investigation reports reveals that human error is one of the top root causes for deviations, discrepancies and quality incidents in pharmaceutical manufacturing. And when you examine the CAPA's that are developed from these, retraining and rewrite of SOP is top the list. Yet on further re-examination, you find that these problems keep resurfacing again and again. Put in another way, the CAPA's a..
Construction Law from Start to Finish
Whether you are new to the construction practice or are looking for a comprehensive refresher, this course will cover multiple issues that must be taken into consideration in the realm of construction law. Join our experienced faculty as they cover a broad, basic overview of the construction process; the fundamentals of construction contracts and key provisions; the basics of insurance; and the impact chang..
Drafting Document Retention Policies
The presentation reviews the basic approach of Information Governance and the importance of getting the relevant stakeholders at the table when drafting a document retention policy. We discuss the importance of document destruction and how to develop a policy that balances the interests of the various stakeholders.Areas CoveredInformation GovernanceObjectivesPolicies and ProceduresRecords Retention and Dest..
From Training to Human Reliability In Manufacturing
Pharmaceutical manufacturing sites continuously compete, even within the same company to maintain production volumes and avoid closures. To attain a status of a high performing organization manufacturing sites are implementing strategies and practices like operational excellence and performance reliability. To achieve this goal, innovative approaches to traditional processes need to take place. This webinar..
How To Navigate Political Speech In The Workplace
Political speech at work is creating more of a problem now than it did during the 2016 Presidential election!!! With the impeachment, divisive country, and upcoming 2020 election, it has escalated even more. A new survey has found that a significantly increased percentage of employees are feeling stressed and strained because of the political speech since the 2016 campaign! Employees are feeling..
How to Set up an Internal Audit Program
An overview of how to set up an internal audit program to address quality management system standards, government regulations, risk management as well as usage for continuous improvement.This is especially useful for small to medium-sized medical device companies and start-up companies to ensure that all of the applicable regulatory requirements are incorporated into the system to ensure compliance with all..
Human Error Reduction in GMP & Manufacturing Floor
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrenc..
Human Factors Validation Testing Following ISO 62366 and new FDA Guidance
Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain the FDA required the number of validation participants from each "distinct user population". We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test...
Impaired Loans: Handle with Care - How to Manage, Account For and Collect Them
Impairment in any form of lending is but a usual mishap that will typically occur, as a rule of the game. For bankers, loan impairment is something to prepare for, as early as before setting up operations, and to permanently upgrade. Failure to do that reveals costly. Refusal to do that, though, deprives the bank of lending premiums, in that the bank will not lend to credit-risky borrowers. Hence it is miss..