Regulatory courses by Cobblestone for the Pharmaceutical and Medical Device Industries
21 CFR 211 Subparts C & D: Facility and Equipment
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence, the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standards for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts C & D: Facility and Equipment
Read More21 CFR 211 Subparts E & F: Control of Components and Production/Process Control
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence, the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts E & F: Control of Components and Production/Process Control
Read More21 CFR 211 Subparts G & H: Packaging, Labeling and Distribution
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American; hence, the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts G & H: Packaging, Labeling and Distribution
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 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 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 MoreFDA Case Scenarios
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 FDA Case Scenarios
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
Read MoreManaging Effective Regulatory Inspections and 483 Responses
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 Managing Effective Regulatory Inspections and 483 Responses
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