Implementing an Effective Regulatory and Policy Change Management Process : 2-Day Workshop

  • Conference / Seminar in Pennsylvania, USA
  • On: 2019/10/03 8:00 To: 2019/10/04 16:00
In this two day workshop we will review regulatory compliance requirements and Policy Management. The course will focus on the design of the risk management, standard operating procedures (SOPs) and ...

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Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)

  • Conference / Seminar in Pennsylvania, USA
  • On: 2019/08/29 8:00 To: 2019/08/30 16:00
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices ...

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GMP Compliance for Quality Control and Contract Laboratories : 2-Day In-Person Seminar by Ex-FDA Director

  • Conference / Seminar in Pennsylvania, USA
  • On: 2019/08/19 8:00 To: 2019/08/20 16:00
This program will cover the requirements for laboratory controls under US GMP regulations and compare them to those applied by other international health regulatory authorities. Laboratory controls relating to equipment ...

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Quality Control Laboratory Compliance - cGMPs and GLPs : One and a Half Day In-Person Seminar

  • Conference / Seminar in Pennsylvania, USA
  • On: 2019/08/15 8:00 To: 2019/08/16 16:00
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical ...

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SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

  • Conference / Seminar in Pennsylvania, USA
  • On: 2019/07/25 8:00 To: 2019/07/26 16:00
One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure ...

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Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings

  • Conference / Seminar in Pennsylvania, USA
  • On: 2019/06/20 8:00 To: 2019/06/21 16:00
Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and ...

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21 CFR Part 11 Compliance for SaaS/Cloud Applications : 2-Day In-Person Seminar

  • Conference / Seminar in Pennsylvania, USA
  • On: 2019/06/13 8:00 To: 2019/06/14 15:00
Course Description :This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated ...

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Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

  • Conference / Seminar in Pennsylvania, USA
  • On: 2019/06/13 8:00 To: 2019/06/14 16:00
This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.It details ...

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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 ......