…process. It’s a case where the customers ideal was an integrated component and the solution was a custom built injection unit to make it happen. Case 3: Here’s an example…
…process. It’s a case where the customers ideal was an integrated component and the solution was a custom built injection unit to make it happen. Case 3: Here’s an example…
…self-training is always a viable option, providing the training is documented, in writing! Furthermore, training of contractors and consultants is also a salient requirement. For example, if you decide to…
…self-training is always a viable option, providing the training is documented, in writing! Furthermore, training of contractors and consultants is also a salient requirement. For example, if you decide to…
Medical device companies must balance a drive for innovation and new product features with an equally intense focus on thorough verification and validation. Hunting a haystack of operating conditions for…
Medical device companies must balance a drive for innovation and new product features with an equally intense focus on thorough verification and validation. Hunting a haystack of operating conditions for…
…and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall: Evaluate and select potential suppliers, contractors, and consultants on the basis…
…and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall: Evaluate and select potential suppliers, contractors, and consultants on the basis…
We continue our discussion on the five key components of micro-molding, with a focus on Prototyping this week (read more articles on Micro-molding here). Here again is another potential barrier…
We continue our discussion on the five key components of micro-molding, with a focus on Prototyping this week (read more articles on Micro-molding here). Here again is another potential barrier…
…complaints. To verify we’ll need to see the complaint data from both facilities. We can analyze that data using a check sheet. Additionally, in the last article we also learned…
…complaints. To verify we’ll need to see the complaint data from both facilities. We can analyze that data using a check sheet. Additionally, in the last article we also learned…
…ensure that: All complaints are processed in a uniform and timely manner; Oral complaints are documented upon receipt; and Complaints are evaluated to determine whether the complaint represents an event…
…ensure that: All complaints are processed in a uniform and timely manner; Oral complaints are documented upon receipt; and Complaints are evaluated to determine whether the complaint represents an event…
We continue our discussion on the five key components of micro-molding, with a focus on Material Selection this week. According to IDES.com Prospector, there are around 86,000 data sheets from…
We continue our discussion on the five key components of micro-molding, with a focus on Material Selection this week. According to IDES.com Prospector, there are around 86,000 data sheets from…
…and specifically, Management Review. Frequently, the doctor likes to throw around one of his favorite terms, the Chief Jailable Officer (CJO), typically the most senior quality/regulatory person at a company….
…and specifically, Management Review. Frequently, the doctor likes to throw around one of his favorite terms, the Chief Jailable Officer (CJO), typically the most senior quality/regulatory person at a company….
…for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Investigations operations manual. (2013). Chapter 5 Establishment Inspections. Retrieved September 8, 2013, from http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf….
…for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Investigations operations manual. (2013). Chapter 5 Establishment Inspections. Retrieved September 8, 2013, from http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf….
