Why is FDA at my facility, and what do I do during an inspection? : 2-Day In-Person Seminar

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/09/26 8:00 To: 2019/09/27 16:00
This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare ...

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Analytical Instrument Qualification and System Validation : 2-Day In-Person Seminar

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/09/19 8:00 To: 2019/09/20 16:00
Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 ...

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Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/09/16 8:00 To: 2019/09/17 16:00
Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in ...

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Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2018/2019)

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/09/09 8:00 To: 2019/09/10 16:00
Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide ...

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Biostatistics for the Non-Statistician : 2-Day In-Person Seminar

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/09/05 8:00 To: 2019/09/06 16:00
Statistics is a useful decision-making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or ...

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Human Error Reduction Program: How to investigate, predict, prevent, correct & recover from Human Error in the manufacturing floor and GMP environments

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/08/01 8:00 To: 2019/08/02 16:00
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires ...

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Packaging and Labeling in Pharmaceutical Production : 2-Day In-Person Seminar

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/07/22 8:00 To: 2019/07/23 16:00
Seminar to help you understand compliant packaging and labeling process in the larger product development from conception of a product to its realization and distribution. Get equipped to reduce cycle ...

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Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/07/11 8:00 To: 2019/07/12 16:00
Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to ...

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Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/07/08 8:00 To: 2019/07/09 16:00
The objective of this two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn which are available and to confirm that those ...

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Biocompatibility Testing for Medical Devices : One and a Half Day In-Person Seminar

  • Conference / Seminar in Massachusetts, USA
  • On: 2019/06/27 8:00 To: 2019/06/28 16:00
The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. ...

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Navratri Festival 2018

The Navaratri festival celebrated in the months of September thru November is a festival of worship, dance and music celebrated over a period of nine nights. The Dandiya is the traditional, folk dance performed with great fervor and enthusiasm. Young ......