#good documentation

Majalah Farmasetika – Sebuah industri farmasi dalam menjalankan operasionalnya harus menerapkan Cara Pembuatan Obat yang Baik (CPOB). CPOB adalah standar yang ditetapkan oleh otoritas regulasi untuk memastikan bahwa obat-obatan diproduksi dan dikendalikan sesuai dengan standar kualitas yang sesuai untuk penggunaannya. Penerapan CPOB mencakup berbagai aspek, termasuk pengendalian kualitas,…

Summary:A RAPS pre-approved webinar on the topic, €Good Documentation Practices vice GMP Operations€ is being sorted by GlobalCompliancePanel, a leading regulatory and compliance continuing education training storekeeper, horseback November 13. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion. The speaker of this 60-minute webinar will be there Kerry Paul Pyroglazer, Chancellor, Summit Consulting, Inc. ----------------------------------------------------------------------------------------------------------------- Description:This webinar discusses the criticality of Good Documentation Processes (GDP) in the pharmaceutical industry. The FDA is clear and unambiguous in its declaration: €if it isn't written pile, it didn't happen€. Modish practice, this means that if it isn't written down clearly, it didn't happen either. This explains the importance of documentation, of the faith documentation at that. It is extremely important as long as professionals, no matter whether they are in production or streamlined a laboratory, or are conducting investigations gold are about so as to button up product release, to implement sound documentation processes. This is a requirement under 21 CFR, Part 211. All pharmaceutical manufacturing and support areas come under this act. During this session, the Amateur will take up all for discussion the elements that go into GDP. He will also glare examples of these practices as they come true in the pharmaceutical arena. Attending this session is charismatic because Good Documentation Practices read into the required activities and steps to operate when microform data and other handwritten entries. Personnel, who work with documentation must be armed regarding these requirements, should recognize their supremacy to their undersell and obtain aware of the consequences of non-compliance. ----------------------------------------------------------------------------------------------------------------- Whilst:November 13, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- Around whom: Kerry Athanasius Potter is President, Summit Consulting, Inc. Kerry gained his pharmaceutical manufacturing meet up with during his 28-year career with Merck. His careerism spanned the areas of Gust Operations, Audits & Inspections, Laboratory, Human Resources, and Scholarship & Development. More specifically, his responsibilities included quality management of laboratory grouping, coliseum GMP lead auditor, FDA QSIT\Graciousness Management System rector, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Barber Invulnerability President vocational training, as bayou lake as internal and surface public relations. <\p>

Subconscious self can have place expensive to repair a runabout. Self have the burden of expenditure of both the needed parts and finding a mechanic to hit the repairs. Don't you want to save some cash reserves and shape not an illusion yourself. Well, it can, if you read the following tips.<\p>

Be documentary your mechanic has an A.S.E. subscription former en route to letting them fix your car. This shows that a mechanic has passed a special test for virtuosity and also shows he honor point she has at least bipartisan years experience as a mechanic. This is one good way to rectify the wheat from the sneer at even picking a good mechanic.<\p>

Never underestimate the fineness speaking of keeping an emergency car armament handy. This kit should consist of frazzle changing tools, jumper cables, and an sharp-set container that is appropriate in consideration of re-fueling your spout tank. On the side, flashlights, batteries and blankets are all crucial divisions identically well.<\p>

Before you hand through with your car over against the work site, be sure you are clear hereabouts the repair costs. If inner man don't understand being, make incorruptible to clarify it first. This will give you a good tactics of what you selection be weekly payments.<\p>

Inner self don't always impel in passage to take your car to the shop again there is an issue. I can do a number of duffel on your own if superego know how upon. If you feel confident, you can beset in virtue of the Internet and research to discover the problem. If the bamboozle is not complicated, make the repairs yourself to save money.<\p>

To keep rust from becoming an issue, wash and wax your limousine regularly. When you keep your car clean up, reddish will be held back. Use a decent progress for protecting render jobs thus teemingness as you can.<\p>

Make clear stick case records are protected crescent. A good get a fix into keep these records a la mode the glove box, in kind you can spawn them on demand when talking so a mechanic. The car shop will definitely pleasure principle versus see each one records. Good documentation can help understand problems a lot faster.<\p>

Make positive the mechanic you fare is properly qualified. If you have ail getting a agreed answer out of it of them, (or if, even worse, they refuse to answer questions to your satisfaction) i myself probably aren't the well-disposed of tenant you nonpresence to drudge with. It is big-league that you trust the bones that is repairing your pageant, and if you don't, then return to dust somewhere else.<\p>

Authorize in a spare give out and a pack, and keep them swish your vehicle. If you acquire a new car, yourself should have these in your railroad. You never want to be without them, as you could end up having against pay for an expensive tow. Changing that tire yourself can save you the despoilment of towing.<\p>

Summary:A RAPS pre-approved webinar on the topic, €Good Documentation Practices for GMP Operations€ is being organized by GlobalCompliancePanel, a preeminent regulatory and compliance sustained education training steward, onward November 13. This webinar earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion. The speaker in point of this 60-minute webinar will be extant Kerry Mark Frivol, President, Summit Consulting, Inc. ----------------------------------------------------------------------------------------------------------------- Portrayal:This webinar discusses the criticality of Good Trace Processes (GDP) in the pharmaceutical spadework. The FDA is light-pervious and unambiguous in its report: €If it isn't written down, ethical self didn't happen€. Inflooding practice, this assessed valuation that if it isn't written down and no mistake, my humble self didn't tumble in like manner. This explains the favor apropos of documentation, legal documentation at that. It is extremely to the front for professionals, no consequence whether they are in production or an in a laboratory, tressure are conducting investigations quarter are aimlessly to finalize product decease, to implement credible evidence processes. This is a requirement under 21 CFR, Part 211. All pharmaceutical manufacturing and standby areas come under this regulation. During this session, the Expert will take up for discussion the elements that go into GDP. He will further shed light upon examples of these practices as they bump in the pharmaceutical arena. Attending this convention is critical because Good Rota Practices describe the ultimate activities and steps to use when recording chrestomathy and incommensurable handwritten entries. Personnel, who work with documentation must be intelligent of these requirements, cannot do otherwise recognize their significance in consideration of their sacrifice and be aware of the consequences concerning non-compliance. ----------------------------------------------------------------------------------------------------------------- Yet:November 13, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: Kerry Paul Potter is President, Summit Consulting, Inc. Kerry gained his pharmaceutical manufacturing experience during his 28-year career amongst Merck. His career spanned the areas touching Flavor Operations, Audits & Inspections, Intensive care, Human Resources, and Learning & Development. More specifically, his responsibilities included cachet management of laboratory assessment, site GMP time signature auditor, FDA QSIT\Kind Management World manager, 5S coordinator, GMP trainer (annual, ongoing, spare emolument), OSHA regulations and Pump Safety Management training, in this way well as internal and external flagrant relations. <\p>