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How the Medical Industry Can Help Combat the Current Coronavirus Crisis

Exeed Regulatory Compliance

Travel is being restricted, large scale public events are likely to be cancelled, and schools and businesses may be closed to contain the spread of the virus. Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. There is now an FDA policy released on 29 Feb.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – May And June

SQA

Additional concerns were noted with respect to: Temperature/humidity controls Calibration inspection and/or qualification of equipment, including computerized systems Equipment usage logs Release of finished products Change Control Records Quality Agreement(s) Specifications for finished products Retention samples Bausch Health, Canada Inc.

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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – July and August 2023

SQA

In addition, it contains essential recommendations to avoid complications and protect public health. While preparing the patient’s compliance pack, the pharmacy misinterpreted the product to contain 500 mg of Calcium Carbonate when each tablet actually contained 500 mg of elemental Calcium. As a result, the patient received 2.5

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