The HACCP methodology as risk management methodology is mandatory for pharma and food manufacturing and quality assurance. A quality assurance department needs to create and maintenance HACCP files documentation and find and define the checkpoints (CP) and critical checkpoints (CCP) in material flow from goods in control over the manufacturing steps until the final goods storage. Which is mandatory for phar..
Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit. Technically, all FDA inspections include an SOP review and it is very important to ha..
ICH Q10, The Pharmaceutical Quality System – Bring the Pharmaceutical Industry Into the 20st Century
ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can be implemented thr..
The webinar will give participants the time to take stock of the immanent changes in the world of work and to be able to come up with the answers to key questionsHow many people do we need to run the organizationPhase one of A.I. Implementation – how much is the Organization likely to saveWhat’s the likely reduction in staffing levelsWhat key HR processes are going to change nowWhat will and integrated A.I...
Leveraging The New Section 199A Income Reduction for Pass-Through, REITS and Owners of Trades or Businesses
In this practical webinar, you will learn to navigate section 199A and identify the key opportunities and issues for you and your taxpayer/clients. You will also receive a list of valuable resources to support you with your more challenging situation.Section 199A provides the opportunity for beneficial owners of pass-through businesses and owners of many other trades or businesses to take a deduction ..
This introduction to signature leadership session will help you understand how to effectively transition to upper administrative and supervisory roles. The session will explore the concepts of supervision of employees, rules, and regulations encompassing the corporate environment, and the various levels of assertive approaches to conflict resolution and hostile workplace prevention through the combined appl..
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..
Form I-9 is required to be completed by all United States employers. It is used to confirm that the new hire is eligible to work in the U.S. The US Immigration and Customs Enforcement Agency (ICE) requires that Form I-9 be completed accurately. Any inaccuracies, even including cross-outs, white-outs, missing information and more, can result in substantial financial or even criminal penalties for emplo..
The healthcare environment creates a major challenge in the prevention and intervention of violence. The rate of injuries and illness from violence in the healthcare industry is more than three times greater than violence in all private industry. Healthcare organizations include hospitals, outpatient clinics, medical office clinics, home health care, home-based hospice, paramedic, and emergency medical serv..
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..
The webinar will describe a process to create quality documents from a blank screen in a timely manner. The process is logical and easily understood. The process describes the location and collection of important information. The process describes how to organize the information collected into a document. The webinar also addresses how to write the document and address comments received from reviewers and a..
For you to achieve outstanding diversity & inclusion results requires strong social intelligence, the ability to evaluate and influence other people’s social interactions. Our evolutionary background has resulted in unconscious bias and other problematic mental patterns (called cognitive biases) that leads to tribal behaviors, undermining D&I initiatives. To deal with tribalism, pioneering organizat..
We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. Defining the functional re..
This webinar will show you that there is no sense in tackling the ‘keeping’ of the records, by trying to follow Part 11, because the record requirements must come from the parties who provide, create, or change the records.If you are part of the process of ‘Collecting’ (e.g.: from study nurse to x-ray specialist), ‘Using’ (e.g.: from sponsor to report programmer, or statistician), or ‘Keeping’ (e.g.: from c..
This webinar will discuss all aspects of the US FDA Pre-Submission process. This webinar will review when a Pre-submission may be appropriate for a company or product. It will include a review of the guidance document. The types of Pre-submissions will also be reviewed including those for IDE applications, study risk determinations, Pre-Sub for a 510(k), Pre-Sub for a PMA and Pre-Sub for an IVD. The content..