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[…]
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)[…]
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)[…]
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[…]
March 4 2013, The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance, the FDA specified new rules for identifying, testing and assuring safety for the systems. The new document overrides the Read more about Guidance on pulse oximeter applications[…]
The FDA’s QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. QSR allocated the information into four documents. The Design History File (DHF) gives a history of device design. One of the design outputs is the Device Master Record (DMR). The Device Master Record (DMR) Read more about Records FDA inspectors look for – related to Quality system[…]
Be specific, truthful, unbiased and scientific Avoid Public responses Keep private response specific to the question Make sure the persons responding on behalf of you are medical or scientific personnel Make sure sales and marketing personnel are not involved at all even in training and awareness Makes sure you are keeping record of all the Read more about Dos and Don’ts of responding to Unsoliciated offlabel requests[…]
One after other drug manufacturing units of India getting warning letters or getting banned to manufacture licenses getting cancelled. Is this a systematic fight back (to the set back of patent disputes in favor of local generic manufacturers) by big pharma by their arm twisting techniques or is it real the plants are not following procedures. Today Hospira’s manufacturing unit in Read more about FDA warning Indian drug manufacturing units – Is it a retaliation to court ruling against Novartis[…]