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..
Key takeaways from this session are a strong set of design research tools, a deeper understanding of Design Driven Development, and insights into how the brain works and what that means for engineers and designers who need to be creative problem solvers. We will also explore effective pathways to collaboration and keys for doing Design Driven Development.Areas Covered The roles of designers and engineers in..
In this session, Mr. Shapiro will provide an overview of the history of the ISO13485 and the newly introduced changes. He will also discuss how the changes interact with regulatory requirements, and how to face the new changes. The webinar will focus on key provisions and considerations when establishing a QMS as per the ISO13485: 2016, and identify pitfalls that should be avoided.On March 2016 ISO – ..
2019 Employment Regulations Are in Place! Employers Must Be Compliant or Face Fines and Penalties in Future Audits! Are You Ready?
Managing these laws will determine how Employers will survive strict fines and penalties as well as create a robust risk management strategy for their workplace.Here are just some of the workplace regulation topics impacted between 2018-2020. How many of these issues are you aware have regulations tied to them?Paid/Unpaid LeaveTransgender Restroom Requirements and Gender Equity and Expression GuidelinesPay ..
Respect in the workplace is not just a good idea, but good for a company’s bottom line. Rude and disrespectful behaviors can create a dysfunctional workplace that pits people against each other, halts civil communications and destroys teamwork. Company culture becomes one of resentment and mistrust. When people can’t work together toward a common goal, the entire company suffers. If bad behaviors like these..
How to Give Corrective Feedback : The C.A.R.E. Model - Eliminating Negative Behaviour, by Focusing on Accountability
In today’s demanding business climate that has an accelerated focus on treating workers right, it is so important to engage their issues with timely action, tact, and communication skills that leaves nothing to chance in corrective measures, for any and all negative situation you encounter. What is the issue you are challenged with? Uncontrolled negativity in the workplace, offensive language, constant and ..
Your elevator pitch is an invitation to get to know you, what you do and to discover any possible connections. Sadly, most people, whether a novice employee, a beginning entrepreneur, or a seasoned corporate executive, do not know how to present themselves well and are losing prospective clients and relationships as a result. Don’t be “most people;” understand how to make the most of those first important o..
Because the use of a vehicle for ‘Company Business’ implies liability, responsibility, and accountability, it is commonly understood that having your Company Name on the door of the vehicle carries with it the aura of CONTROL!The legal community knows this, and you should understand it as well. We are a vehicle-based highly mobile society, and most persons will drive a Company vehicle or ride in one at some..
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning let..
Reducing turnover and fast-tracking new employees to productivity is a key business imperative. The reality is that about 30% of employees don’t make it past their first year and it’s expensive. Good recruitment and hiring can be quickly undone by disorganized poorly executed new employee orientation. And as millennials become a driving force in the workplace, they represent special opportunities and challe..
Managing and reducing cost continues to be one of the primary focal points of business and governments today. In many organizations, more than half of the total revenue is spent on goods and services—everything from raw material to overnight mail. Maintaining a competitive position and even survival will depend on the organization's ability to use all of the continuous improvement strategies which have been..
Creating a positive culture of acceptance and inclusion includes understanding how to tap into the hidden power of employees’ differences and create a work environment where everyone thrives. Diversity can be the root of conflict in the workplace if not managed and when conflicts go unresolved, animosity and distrust can build up on teams.Diverse organizations and teams can yield innovative results, however..
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..
In this webinar, we will review the steps in effectively eliciting requirements, discuss some of the common challenges, and review solutions to these obstacles.Different stakeholders have different personalities and communications methods, so the person responsible for documenting requirements needs to have an adaptable approach. In this webinar, we review the different approaches and when they would be bes..
Due to the aging of the world population, co-medication is becoming more and more frequent. This increases the risk of clinically relevant Drug-Drug Interactions (DDI) that cause morbidity and, in some cases, withdrawal of approved drugs from the market.Clinically relevant DDIs between an investigational drug and other drugs should, therefore, be investigated during drug development via non-clinical and cli..