Additional Content
Episode 4: ISO vs. cGMP vs. FDA Requirements.
In Episode 4 of this 10-part series, Product Owner Manager Dave Latimer and Principal Product Management Director Terrance Holbrook discuss FDA requirements and how to comply with them.
15:56Episode 5: FDA Current Guidance and Exemptions
In Episode 5 of this 10-part series, Product Owner Manager Dave Latimer and Principal Product Management Director Terrance Holbrook talk specifically about how digitizing helps with the complexity of
FDA Fronts Pivotal Life Sciences Trend in 2020
This publication provides an in-depth look at the FDA’s transformation and addresses how the agency’s initiative will impact manufacturers of regulated products.
Common Reasons for FDA 483 Inspectional Observations in Biologics Manufacturing Environments
Learn about the most common 483 observations and audit findings, and avoid warning letters by staying compliant and addressing issues in the stipulated time period.
Annex 11 and 21 CFR Part 11: Comparisons for International Compliance
The two essential resources regarding the validation of computer systems are: the FDA’s 21 CFR Part 11 and the EMEA Guidelines to Good Manufacturing Practice (GMPs) - Annex 11, Computerized Systems.
21 CFR Part 11 Compliance Checklist
If your company is planning to convert to an automated system for managing documents and processes, make sure the new system meets the needs outlined in this 21 CFR Part 11 Compliance Checklist.
1:20Completing an FDA Inspection With MasterControl
MasterControl customer Contract Pharmacal Corporation used to be a paper-based organization. They’ve greatly benefited from switching to MasterControl’s electronic quality management system (QMS).
FDA/ISO Compliance Toolkit
Medical device managers are complying with FDA requirements and better aligning with evolving industry trends by recognizing the value of moving to a digital quality management system.
Ten Most Common Reasons for FDA 483 Inspectional Observations in Pharmaceutical Environments
The U.S. Food and Drug Administration has released data on the most common observations it makes during inspections of pharmaceutical facilities. This white paper explores the top 10 deficiences.
FDA Inspections of Clinical Investigators: Are You Ready?
In the United States, the Food and Drug Administration (FDA) has a number of guidances that are meant to strengthen its oversight of clinical investigators and clinical trials.
11 Free Resources to Boost Your Medical Device FDA Readiness
This FDA Readiness Toolkit is designed to help medical device manufacturers simplify compliance with FDA standards and streamline quality-related processes.
How to Successfully Complete an FDA Inspection
This white paper provides an overview of the inspection process, describing the preparation for an inspection, what will happen during an inspection, and what to expect after an inspection occurs.
The Value of Studying and Utilizing FDA's QSIT Manual
The FDA’s approach to the inspection process of medical device manufacturers, Quality System Inspection Technique (QSIT), embraces a top-down inspection of a firm’s QMS.
MasterControl eMDR™
The FDA requires medical device manufacturers to report any adverse events to the agency.
51:38Working on a Post-Inspection FDA Response - MasterControl
After an FDA investigator has inspected your facility and issued a Form 483, it is critical to meet the post-inspection response requirements. Failure to do so can have devastating consequences.