Drawing from over 20 years of industry experience, gain valuable insights and expert perspectives from a trusted microbiology quality assurance leader and internal auditor.
“What should be the temperature for Purified water used for Equipment washing and Manufacturing of Oral solids? Should it be 60-80C or it can be used at 22C with circulation of water? Need references“
“Dear Experts, What are the guidelines that clarify the frequency and number of cycles required for re-Validation of equipment? For example, during re-qualification of the autoclave should each cycle be repeated 3 times (empty, minimum and maximum loads)? Or is it based on risk assessment by choosing the maximum loads only? (On initial qualification each cycle was performed 3 times consecutively). Also for depyrogenation tunnels, should the runs be repeated 3 times? Thank you“
“Can we provide the grades of pass box and lafs in on critical area with respect to material movement ? For example if a pass box installed between grade c and grade d environment can be designated as grade b? Similarly laf installed in grade c area can be designated as grade c? If yes what woukd be the viable and non viable limits to be applied?“
“I have been working with an academic team of global R & D partners on TECH DOC, Product Support, Training, and Learning/Development solutions. One item on the hot list is the ability to manage the release of the software/device exactly with the support mechanisms such as the KB, the release notes, and the manual/quick start guide. Across several sectors, this issue seems to exist. How do I save the most time, yet not overwork the team, and remain as precise as possible without creating confusion for the internal teams/external teams? Any product manager, project managers, or other TECH DOC specialists care to share how to provide precision across the different LOBs in a global environment where time zones matter?“
