Why do some organizations and their leaders falter during times of uncertainty while others succeed in chaos and find ways to adapt? At its core, successful change depends on whether your people, at all levels, can adapt to new ways of thinking and operating as well as whether teams and workgroups can quickly adapt together. Research has found that the single most important factor for adapting to change is ..
The phrase “getting the right people, in the right place, with the right skills, at the right time, and at the right cost” is synonymous with the most common type of long-term forecasting: strategic workforce planning. The methodology, in which HR and their business partners forecast – in time horizons ranging from 3-10 years – the demand for, and supply of, labor has been deployed extremely successfully in..
Mr. Yuval Shapiro shall review the basic statistics that are behind the Sample Size selection. Explanations on how to select samples for the Design (verification and validation) phase, and for the Production phase. Also, explanations on how to use the ISO2859-1 for simple cases at production shall be provided. Selection of the correct sample size is a challenging task, especially, when regulatory authorit..
An out-of-compliance under GLP or ISO 17025 is a discreet and specific event. Its occurrence has major consequences for the laboratory operation. Can the incident and its timing give clues to what caused the non-compliance?The records in a lab – the logbooks for chemicals, reagent and calibration solutions, for sample preparation, for instrument maintenance and calibration, for quality checks – all are ..
Customers will always buy based on their expectations & perceptions. And they will share those expectations & perceptions. A customer satisfaction survey effectively designed & conducted - with an action plan implemented around the feedback - will more than pay for itself.Designing & conducting an effective customer satisfaction survey involves the following key initiatives:#1 Identify..
This course provides guidance on how to perform QC analytical test method validations and transfers. One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH, and USP have each recognized the importance of th..
AI/ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following de..
Guidance For Industry - Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) Of The Federal Food, Drug, and Cosmetic Act
On December 23, 2019, the Food and Drug Administration (FDA) issued a proposed rule and draft guidance to facilitate the legal importation of certain drugs, which the FDA and the Department of Health and Human Services (HHS) first described in a July 31, 2019, Safe Importation Action Plan. The Safe Importation Action Plan (SIP) introduces two possible pathways for such importation.FDA has issued the GUI – I..
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the “Post-Market-Surveillance-Process” and the new requirements e.g. reporting to Authorities and Notified Bodies and how this process is connected to other processes. The understanding of these changes and how to implement last-minute changes until May 2020 is essential to ke..
The majority of people set goals based on what they think they should do NOT on what they will do. Setting goals that do not align with the values of the individuals involved will ultimately fail. Learn a simple Brain Technique that will assure you or your company are matching your values with your goals. Value-Based Goals align you with what you most want to become. Discover your core values and how to inc..
The purpose of verification and validation is to hunt for oversights and omissions in design, manufacturing, and servicing. Who is verifying and who is validating is a very important consideration. An independent, unbiased, and one with a full understanding of risk analysis would be an ideal participant. This is not always viable. The next best thing to then is to have a small team (5 to 7 people) to get a ..
Working Staff at home: How to Get More Productivity and Profitability from Employees Working from Home
After COVID-19: 60% of white color-workers want to work partly (40 – 60% of their working hours) from home. Working @home and the related products are very important issues within organizations; first, the personal issue for the employee, secondly to prevent the production losses for the company.Working@home: how do you manage this and what about the loss of productivity? And is there a loss?In addition to ..
It is difficult to get everything you need for a credit report as most of them have outdated financial information. One of the best things you can do especially for your major customers is to get audited financial statements. Any account that you sell to that is publically traded has financial statements available on their State’s SEC.GOV website. Once you have the financial statements you now hav..
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces a produc..
Missteps in handling sensitive employee issues could result in your organization writing a check with a lot of zeros on it. How companies investigate potential harassment and bullying misconduct can affect your organization’s reputation as well as its bottom line. Cultural and generational diversity is changing the landscape of the US workforce. That diversity can become fuel for all types of litigation. Un..