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John Robinson's Blog – June 2017 Archive (9)

Safety Management and OSHA Compliance

Safety Management and OSHA Compliance 1

Why is Occupational Safety and Health Administration (OSHA) compliance necessary? For a simple reason: OSHA compliance is the surest legal way of ensuring safety at the workplace. Safety management and OSHA compliance go hand in hand and are deeply connected to and intertwined with each…

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Added by John Robinson on June 28, 2017 at 6:15am — No Comments

Documenting Software for FDA Submissions

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The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing.…

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Added by John Robinson on June 27, 2017 at 6:15am — No Comments

All about biosimilars –from development to registration

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Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.

There is a misconception that they are similar to or are the same as generics, but this is not so in…

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Added by John Robinson on June 27, 2017 at 6:01am — No Comments

HIPAA compliance expectations from Small Healthcare Providers

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Added by John Robinson on June 14, 2017 at 6:28am — No Comments

Change Control is at the core of GMP Compliance

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Added by John Robinson on June 13, 2017 at 6:46am — No Comments

Quality by Design using Design of Experiments

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Added by John Robinson on June 8, 2017 at 6:48am — No Comments

Writing and implementing effective SOP’s

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Added by John Robinson on June 6, 2017 at 6:36am — No Comments

Validation the complies with ICH guidelines



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Added by John Robinson on June 5, 2017 at 7:26am — No Comments

Four years of the EU’s Cosmetics Product Regulation

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Added by John Robinson on June 2, 2017 at 6:18am — No Comments

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