Course "Design of Experiments and Statistical Process Control for Process Development and Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will present the procedures that must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. A practical approach with case s...

Overview: A detailed look at each section of the standard. Real world examples of what to expect, and what to prepare and repeal within the audit guidelines. What must a documentation system look and feel like to ensure compliance? These and many other key details to ensure that your organization has the ability and knowledge to ensure that ISO 13485 is within your grasp. Clean rooms 101, we can assist in what to do and what not to do. From th...

Overview: HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas, help...

Overview: We engage most of your senses. You will read short lessons, write action plans, discuss issues with others, ask questions and provide answers as well as make and keep commitments to yourself and the group. Focus is on five basic skills: goal clarity, team building, personal organization, communication and increased productivity. Its fun, fast paced and you will be delighted with your growth. This is not sitting for hours and listenin...

This course goes into great detail regarding your practice or business and how it relates to the HIPAA Security/Privacy Rule. We will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. We will also speak to real life audits conducted by the Federal government (Brian Turtle has been...

Course "Predicting and Improving Product Reliability" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Although a primary objective of reliability analysis is to improve product reliability, there are many possible reasons for collecting and analyzing reliability data. Several examples are the following: Assessing product reliability in the field Predicti...

Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal r...

Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory env...

Overview: This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate...

Overview: I have conducted over 400 risk assessments for business associates and covered entities alike as well as worked directly with the Federal government in terms of auditing. This seminar will go into great detail about what is going on in the HIPAA Security/ Privacy world. I will discuss why the government is all of a sudden going full bore in demanding compliance. You will learn risk factors to avoid, best practices you should be doing...