Medical devices span the therapeutic spectrum, from the toothbrush to life-saving heart implants. Even in simple devices, complex engineering challenges can arise that must balance mechanical, biological, regulatory, and other factors.
Frequent training is necessary to stay current on the practical demands of adhering to medical device regulations and validation processes, and helps ensure your manufacturing process will produce devices that conform to the approved design characteristics.
Writing Standard Operating Procedures (SOPs) for Human Error Reduction
Poorly written SOPs are responsible for over 40% of human error events in manufacturing and are the leading cause of regulatory citations. Well-crafted procedures are critical for both successful execution and regulatory compliance. Proper procedures need to be clear, user-friendly, and include all necessary information for regulators. However, many procedures are flawed, leading to decreased… Continue reading Writing Standard Operating Procedures (SOPs) for Human Error Reduction
Read MoreAdvanced Stability Operations for Drugs, Biologics, and Medical Devices
New to “stability”, or a key stakeholder in the stability process, or just want to firm up your stability knowledge? Our 3-part series on Stability Operations for Drugs, Biologics, and Medical Devices will give you a rock-solid base for establishing or expanding your stability operations knowledge. Depending on your level of understanding, you can enroll… Continue reading Advanced Stability Operations for Drugs, Biologics, and Medical Devices
Read MoreIntermediate Stability Operations for Drugs, Biologics, and Medical Devices
New to “stability”, or a key stakeholder in the stability process, or just want to firm up your stability knowledge? Our 3-part series on Stability Operations for Drugs, Biologics, and Medical Devices will give you a rock-solid base for establishing or expanding your stability operations knowledge. Depending on your level of understanding, you can enroll… Continue reading Intermediate Stability Operations for Drugs, Biologics, and Medical Devices
Read MoreIntroduction to Stability Operations for Drugs, Biologics, and Medical Devices
New to “stability”, or a key stakeholder in the stability process, or just want to firm up your stability knowledge? Our 3-part series on Stability Operations for Drugs, Biologics, and Medical Devices will give you a rock-solid base for establishing or expanding your stability operations knowledge. Depending on your level of understanding, you can enroll… Continue reading Introduction to Stability Operations for Drugs, Biologics, and Medical Devices
Read MoreSabrina Ippolito
Sabrina Ippolito, is an accomplished expert in quality systems with over 15 years of experience in the industry. She holds a Bachelor’s degree in Biochemistry and is currently working towards completing her Master’s degree of Education in Adult Education, in addition, she is a member of the professional order of Chemists of Quebec (OCQ). Throughout… Continue reading Sabrina Ippolito
Read MoreMastering Quality Management Systems (QMS)
A Quality Management System (QMS) guarantees that products or services consistently fulfill or surpass customer expectations. Emphasizing quality enables organizations to boost customer satisfaction and loyalty, resulting in repeat business and positive feedback. In this fully accredited course, we’ll discuss how implementing a QMS involves several fundamental steps to ensure its effectiveness and success. Each… Continue reading Mastering Quality Management Systems (QMS)
Read MoreEquipment Qualification in the GxP Environment
Whether your operation is covered by GMP, GLP, or GCP, there is a regulatory requirement to ensure that all equipment used has been properly demonstrated and documented to be functioning properly. Commonly referred to as Installation Qualification, Operational Qualification, and Performance Qualification, IQ/OQ/PQ provides the framework under which this process can be appropriately performed. Overlooking… Continue reading Equipment Qualification in the GxP Environment
Read MoreSupervising a Human Error Free Environment
Supervision plays a crucial role in Human Error Reduction and Control. In this fully accredited training, critical factors like preparation, planning, scheduling, communication, among many others, will be discussed. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of… Continue reading Supervising a Human Error Free Environment
Read MoreGMP Change Control Process
Change control is a requirement of all regulatory agencies and authorities worldwide. It is a critical GMP function that must be addressed daily. The value of identifying and tracking change is to prevent unintended consequences, remain in proper process alignment, and avoid any alteration of the products’ Safety, Identity, Strength, Purity, and Quality (SISPQ). Many… Continue reading GMP Change Control Process
Read MoreIntroduction to Validation Principles, Practices and Requirements
FDA-regulated industries utilize several types of validation to help ensure the quality of their products and to comply with FDA and international regulations and requirements. This training course provides an overview and introduction to Validation principles and requirements. Process validation, Computer System Validation, Cleaning Validation, Methods Validation, Qualifications, and Validations Project Management are all topics discussed in… Continue reading Introduction to Validation Principles, Practices and Requirements
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