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FDA and other global regulators expect to see appropriate processes to account for human factors and usability in a range of products to ensure that they are safe and effective at the end-user level.   Human Factors refer to how people interact with technologies and system design.  Usability refers to the quality of a person’s interaction […]

Are you a small pharma firm anticipating your first FDA pre-approval inspection (PAI)? Or are you looking for information about PAI trends in the wake of the pandemic? Do you know which leading CMO has had the most PAI experience in the last five years?  On Tuesday, August 2, 2022, Redica presented the webinar, “A […]

The Critical Role of Management Engagement in Quality Culture What can regulatory documents and FDA Warning Letters issued in 2021 tell regulated industries about data integrity trends? And why should industry leaders develop a data culture mindset? During a session at the 2022 PDA Annual Meeting, Ulrich Köllisch, PhD, Manager of Data Integrity at GxP-CC, […]

Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles. What are the number of FDA 483 observations involving change control procedures over the past ten years? Effective change control procedures […]

  Process validation is a crucial element for any GMP operation.  FDA defines process validation in the Agency’s 2011 guidance “as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”  That same guidance document emphasizes that […]

Over a four-year period, FDA issued five warning letters to a physician and associated entities and organizations—one from CDER for marketing unapproved new drugs, and four related to clinical studies under the Bioresearch Monitoring (BIMO) Program. This is the first time a single individual or entity has received four BIMO warning letters, all for different […]

Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles. What are the latest FDA enforcement trends when it comes to lack of contamination control? Contamination in manufacturing is an issue […]

If you are a medical device manufacturer, your products must address global unique device identifier (UDI) requirements. A UDI is a mark that identifies medical devices throughout the supply chain from manufacturing to distribution to patient use in order to ensure patient safety. Many countries and regions have their own specific medical device UDI requirements, […]

Companies that do not invest in and continually improve their laboratory instruments risk regulatory enforcement actions involving data integrity, according to two industry experts.  Pharma consultant Bob McDowall and Paul Smith, Global Compliance Marketing Specialist at Agilent Technologies, presented their findings during the May 24 webinar, “Are Laboratories Perpetuating Data Integrity Problems?” Part I examines […]

Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data.  I’m comparing the enforcement histories of two CMOs’ sites over a ten-year period. How can I quickly and easily find this information? At Redica, we recognize that ensuring quality and compliance at contract […]