Quality & ISO 9000 Compliance Management Training

In this training, learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.

Events in the world are affecting how we do business with travel restrictions we face new uncharted waters, Companies need to maintain their certifications / suppler status and are required to be audited either by a CB or a customer periodically. To protect the client and the auditor remote auditing has been proposed as the solution. The big question is how do we prepare for a remote audit? What are some challenges and how do we address them? Some guidelines have been flowed down from Certifying Bodies to their auditors. This session will share those guidelines and help you prepare for a successful remote audit.

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.

This webinar will teach you how to identify potential process problems and avoid process interactions through effective process mapping. It will cover steps to create a fishbone diagram including its purpose, advantages and how to present it.

This webinar will explain how to create Failure Mode Effects Analysis (FMEA) by combining Effective Information Collection (EIC), Process Reliability Modeling (PRM) and Failure Mode Effect Criticality Analysis (FMECA). It will also cover the methods for determining root causes of process problems and effective tools for repair of ineffective processes.

This webinar will discuss in detail Process Reliability Modeling (PRM) method including its history, the process, validation, and results of effective management, sigma score and customer satisfaction. Attendees will learn how to convert qualitative information into quantitative data to determine process and system reliability.

Join this webinar to learn how to perform a Severity, Frequency Cost Benefit Analysis to determine if a bar other than the tallest is addressed first. Selecting the wrong bar (problem) may cause an organization loss of revenue, accident or possibly serious injury.

In this supplier management webinar attendees will learn the practical risk-based approaches to selecting, qualifying, and managing your business’ suppliers of all types. Also attendees will learn how to establish a PDCA-based supplier management process.

This webinar will discuss practical approaches to creating a more concise and effective Quality Manual that employees will actually want to read, and auditors will praise.

This webinar will discuss how to monitor and measure quality system process conformity and effectiveness as required by ISO 13485 and ISO 9001 in ways that will actually result in operational improvement.

This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.

In this webinar attendees will learn the proactive methods of process reliability modeling (PRM) to eliminate and manage the five systemic problems (Confusion, Conflict, Complexity, Chaos & Cost) in organizations that resulting significant financial losses.

This webinar will teach you how X-Bar and R Charts are used to identify and analyze variation within transactional and manufacturing processes. All Processes in an organizations need to be protected and monitored so monitoring control charts offers Process Owners a way to determine if their processes are in control, capable and stable.

Reliability methods such as Process Reliability Modeling (PRM) is a very sensitive measurement instrument used to identify areas of medical processes contributing to employee or patient dissatisfaction and loss of revenue. This webinar will discuss the proactive methods such as Process Reliability Modeling will result in processes that are effective, efficient and reliable.

This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data.

This webinar will provide an overview of SEC Whistleblower Rules such as False Claims Act, Dodd-Frank, Sarbanes-Oxley and Commodity Exchange Act. It will also discuss best practices on how to mitigate damages from an actual or purported whistleblower.

This webinar will provide valuable assistance to all regulated companies; a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

The objective of any report is to provide important information to management in the area reviewed. It represents the end result of weeks of reviews, analyses, interviews and discussions. The quality of that report will have an impact on how well the report is understood and accepted. This training program will review the audit standards related to audit report quality and encourage attendees to participate in various quality report exercises.

Project risk management includes the processes of conducting risk management planning, identification, analysis, action planning, and controlling risk on a project. This training program will analyze the objectives of project risk management - to increase the likelihood and impact of positive outcomes while decreasing the likelihood and impact of negative events affecting the success of the project.

This training program will help attendees grasp the essentials of project management and plan effectively for identifying project needs. It will also discuss practices for keeping content, process, and structure on track to produce positive outcomes.