FDA Guidance on Computerized Systems Used in Clinical Investigations

Posted on July 30, 2020July 30, 2020 by admin

Scope Computerized systems that contain data that support a marketing application Case histories Analytical test results (e.g., LIMS) Data captured from analytical instruments Electronic transcription of hardcopy source data it Does not apply to Computerized medical devices* Study Protocols •Identify computerized system use within the trial process •Computerized systems must: –Satisfy process requirements defined in Read more about FDA Guidance on Computerized Systems Used in Clinical Investigations[…]

FDA inspection & Top Reasons for FDA inspection

Posted on July 30, 2020July 30, 2020 by admin

NAI – No Action IndicatedSite is in compliance. No actions or response from site necessaryVAI – Voluntary Action IndicatedViolative practices noted that do not immediately jeopardize subject safety, but require correction action. Response necessary; follow-up inspection possibleOAI – Official Action IndicatedViolations severe enough to warrant immediate administrative actions. Reinspection likely Other InspectionsRoutine GMP auditsDirected audit Read more about FDA inspection & Top Reasons for FDA inspection[…]

Dos and Don’t during and after FDA inspections

Posted on July 30, 2020July 30, 2020 by admin

This is a collection of facts from different experts and not the whole thing, there might be other dos and don’ts other than these applicable as per particular situation. Dos Present business card Be prepared Be organized Be calm Be professional Be confident Have Scribe present at all times during the interview Leave as soon Read more about Dos and Don’t during and after FDA inspections[…]

Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)

Posted on July 30, 2020July 30, 2020 by admin

see that corrective action taken to correct existing product nonconformity or quality problems and Prevent recurrence of the problem The corrective action should Include explanations for how the firm will meet the requirements for all elements of the CAPA subsystem Gain working knowledge of the firm’s CAPA procedure before beginning evaluation of this subsystem Have Read more about Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)[…]

FDA Validation compliance

Posted on July 30, 2020July 30, 2020 by admin

Q – difference between GMP & cGMP ? Ans -Essentially GMP and cGMP are one and the same with one significant distinction; the “c” denotes current. It is my understanding that the FDA (Food and Drug Administration) included the word “current” to ensure that regulated firms use the most current Good Manufacturing Practices (I believe that Read more about FDA Validation compliance[…]

FDA Documentation Compliance

Posted on July 30, 2020July 30, 2020 by admin

Q – What would the FDA think about test documents with actual results typed in instead of being handwritten? Details – With global teams we have to do a lot of scanning of documents for pre and post execution review, some would like to type the results and signatures so they can be reviewed more easily Read more about FDA Documentation Compliance[…]

FDA Compliance General (Med device, Pharma, Biotech)

Posted on July 30, 2020July 30, 2020 by admin

Q – How can you define a varying load in sterilant? Answer -Usually the load selection is done by reviewing all the products in the sterile family and making a judgement. It may be helpful to get a bunch of product samples on a table in the conference room, and have a meeting with the Read more about FDA Compliance General (Med device, Pharma, Biotech)[…]

Guidance document on the management of design and process changes

Posted on July 29, 2020July 29, 2020 by admin

To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of the Read more about Guidance document on the management of design and process changes[…]

California Hazardous Waste Regulations

Posted on July 19, 2020 by admin

California has unique hazardous waste regulations that include, but substantially exceed requirements of the federal Resource Conservation and Recovery Act (RCRA) regulations generally in effect in other states. It is also hard to navigate California’s hazardous waste requirements because of the dramatic differences in substantive requirements, enforced by pervasive local city and county agencies deputized Read more about California Hazardous Waste Regulations[…]

EBA Guidelines on Internal Governance

Posted on July 19, 2020July 19, 2020 by admin

In the European Banking Authority’s (EBA) new Guidelines on Internal Governance the aim is to enhance and consolidate supervisory expectations and improve the implementation of internal governance arrangements for individual institutions and the banking system as a whole It has 6 key sections . 1 -Corporate Structure and Organization The management body should ensure that Read more about EBA Guidelines on Internal Governance[…]