Tag Archives: start

  • Should we be using iPhone video procedures?

    … without it becoming a regulatory limitation. The time is right to be bold and start to employ modern ideas for a 21st century business!   Let’s keep the conversation going. What are your thoughts on this issue? Does the pharmaceutical industry need to “join the 21st century”? We would love to hear from you! Comment below or visit our social media networks to keep talking about this topic.  …

  • Fall Networking Event, a Success!

    On October 9th, SCG proudly kicked off a new networking event series with our friends from Walnut St. Labs. The event took place at Teca restaurant, right in the heart of the borough of West Chester, Pa. Smart Consulting Group’s president, Denise Smart, hosted events of this nature several years back, so the time had come to start off this tradition once again. SCG invited local professionals in the life sciences industries, while Walnut St. Labs opened it up to many other local business …

  • Waste Removal

    … as “low hanging fruit” components. Before going ahead and investing major time and effort into complex waste removal practices start with the materials that can most obviously be considered waste. Although this seems logical, many would be surprised at how many researchers overlook this step in lean biomanufacturing and instead strategize complex methods for removing harder to eliminate waste. Don’t fall victim to this practice. Don’t overlook the obvious. The effort to remove the most …

  • Do Start up Life Science Companies need Quality Management Systems?

    So you may be a start-up or virtual life sciences company, but you still have a requirement to have a Quality System to develop your pharmaceutical/life sciences products. That’s true if you are a company that is regulated by the FDA and major international regulatory agencies that conform to ICH guidelines. Although you’re not likely to be inspected as an early stage company, regulators still expect that developers of human products must be stage appropriate managed in terms of compliance …

  • The Right Sequence for Lean Manufacturing Implementation

    For a pharmaceutical manufacturer, implementing lean manufacturing can be a fairly seamless and efficient process.  It can also be fraught with resistance, incorrect perceptions and end up only a partial implementation.  The negative perceptions and attitudes that impede a successful, effective implementation of lean manufacturing solutions generally start at the top, and is where lean manufacturing consultants can provide the most effective assistance and guidance. The manufacturing arena is …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    … understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason. This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the blood cell system, …

  • How to Perform a Mock Audit

    … regulatory knowledge, data validation, observance of SOPs, and compliance documentation. Even more so, include an educational program into the mock audit process.  Define how and when the participants will be “debriefed”, and how you will follow up on the lessons learned from the exercise. Once you start the mock audit, make it as real as possible.  Follow a clear plan and treat the mock inspector exactly as you would treat the real one.  Everyone must remain “in …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    … If scientists understand what is going on when tissues are regenerated under normal circumstances, they can start working on how to replace damaged or sick organs, tissues, and cells in an organized and safe way after an injury has happened for any reason. This kind of knowledge would be very helpful for treating Alzheimer’s, for example, and scientists would also be able to measure the consequences of what happens when stem cells go wrong during the normal renewal processes, like in the …

  • Management Responsibilities and Automation Techniques in Regulated Pharma Environments as Per a Suggested Quality System Model

    … regulations, the FDA’s Critical Path Initiative, ISO 9000 standards, and/or the requisites of foreign regulatory bodies. However, in the ‘Quality Systems Approach to Pharmaceutical cGMP Regulations’ support document, the FDA introduces a potential Quality Systems model that could offer the elements that pharmaceutical companies require to start, or keep on, growing a top-functioning Quality System capable of meeting the institution’s regulations and requisites. The quality …

  • What You Need to Know About Vendor Audits

    … provide a great value to your company and organization, especially, in the system implementation and validation process.  It allows for vendors and buyers to quickly establish relationships that will not only increase product quality, but reduce duplicated testing efforts, and start a new and constructive dialogue between buyer and vendor.  To learn more about how to properly administer vendor audits in your company, contact a leading pharmaceutical consultant in your area. If you liked this …

  • How to Get Through a Successful Pre-Approval Inspection

    … its pre-inspection test.  For your company to prepare itself sufficiently, many pharmaceutical experts recommend that your company start preparing itself at least 12 months prior to the inspection date.  One of the best things your company can do to ensure maximum preparation, is to hire an outside pharmaceutical consulting firm, or life sciences consulting firm, that specializes in pre-inspection audits, and can help your company to prepare itself the best way you can for your pre-approval …