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.
Microbiology for the Non-Microbiologist
Appropriate as a GMP Microbiological Refresher With the increasing number of Regulatory Actions throughout North America to include Form FDA 483s and Warning Letters for both Active Pharmaceutical Ingredients (APIs) and finished products, it has become increasingly important for companies and individuals manufacturing both non-sterile and sterile final products, to have a basic understanding of… Continue reading Microbiology for the Non-Microbiologist
Read MorePharmacopoeia Compliance: An Overview [FREE WEBINAR]
Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopeia is applicable. This fundamental, and often misunderstood – principle is an important consideration throughout the drug product life cycle across the bio/pharmaceutical industry. Ensuring pharmacopoeia compliance is often complex and the… Continue reading Pharmacopoeia Compliance: An Overview [FREE WEBINAR]
Read MoreComplaint Handling Requirements (US)
Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities. The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard.… Continue reading Complaint Handling Requirements (US)
Read MoreImplementing a Change Control Quality System Successfully
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Implementing a Change Control Quality System Successfully
Read MoreApplying Quality Risk Management
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Applying Quality Risk Management
Read MoreCAPA: Definition, Plan and Program
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading CAPA: Definition, Plan and Program
Read MoreData Integrity
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Data Integrity
Read MoreBest Practices for Investigation Deviations and Non-Conformances
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Best Practices for Investigation Deviations and Non-Conformances
Read MoreConducting Successful Quality Audits: Best Practices for Managing Inspection Situations
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations
Read MoreCapturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if… Continue reading Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
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