Dot Compliance

JULY 12, 2024

Implementing an electronic quality management system (eQMS) is crucial for organizations in the pharmaceutical industry. Below are ten of the reasons why an eQMS is critical for pharmaceutical companies: 1. Regulatory Compliance The eQMS helps ensure compliance with regulatory standards.

Pharmaceutical Industry 52

Pharmaceutical Industry Regulatory Compliance Compliance FDA 52

Healthcare IT Today

JANUARY 8, 2024

It is key for pharmaceutical companies to recognize that efficiency does not override compliance, patient safety or regulatory standards. While each company successfully gained FDA approvals, the current market acceptance for prescription digital therapeutics is low and improvements will take years.

Pharmaceutical Industry 91

Pharmaceutical Industry Due Diligence Compliance Regulatory Compliance 91

HIT Consultant

AUGUST 16, 2023

Accelerating the Adoption of IDMP-O to Simplify and Standardise data Assets “Fluree is a perfect fit for pharmaceutical organizations seeking to balance regulatory compliance with innovation and accelerate drug discovery, efficacy and efficiency,” said Eliud Polanco, Fluree president. years, with only a 7.9% years, with only a 7.9%

Pharmaceutical Industry 52

Pharmaceutical Industry Regulatory Compliance FDA Compliance 52

Dot Compliance

SEPTEMBER 30, 2022

The Pharmaceutical Quality Management System (QMS) is a collection of activities and processes that improve the quality of the pharmaceutical product. It focuses on specific persons and processes involved in the production of goods and stops them from straying from quality standards like FDA 21 CFR Part 11, ISO and ICH Q10.

FDA 52

FDA Pharmaceutical Industry Compliance 52

HIT Consultant

NOVEMBER 17, 2021

Recent statements by the FDA and EMA support this emphasis, calling out the need for education and training of all constituents in a clinical trial to reduce unwanted protocol deviations and improve overall quality in clinical trial operations. Improving Protocol Compliance. About Robert Geckeler.

COVID-19 97

COVID-19 Pharmaceutical Industry Informed Consent Compliance 97

HIT Consultant

MAY 31, 2023

The pharmaceutical industry has experienced a wave of accelerated consolidation since 2010. In 2019, the industry saw a record-breaking 1,276 pharmaceutical M&A’s , representing a total value surpassing $411 billion. In 2017, only four companies were responsible for 50% of generic pharmaceutical drug production.

Pharmaceutical Industry 96

Pharmaceutical Industry Hospitals Telemedicine FDA 96

Dot Compliance

SEPTEMBER 11, 2022

The following is a list of some of the most prevalent rules and regulations that apply to the Pharmaceutical Quality Management System (QMS). Organization for International Standardization (ISO): ISO is a global organization that creates standards for a variety of sectors, including the pharmaceutical industry.

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance FDA Regulatory Compliance 52

HIT Consultant

MAY 30, 2024

With more than a decade of effort, the pharmaceutical industry has established agreed-upon methods and technologies to exchange transaction information, verify product information, and track products throughout the supply chain, thus improving the security of the U.S. drug supply chain. .”

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance FDA Hospitals 52

HIT Consultant

AUGUST 18, 2021

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA. The pandemic has given rise to new norms in drug development that will influence the future of the industry as we know it. Food and Drug Administration (FDA), along with greater flexibility around mandates on alternatives to traditional clinical information.

COVID-19 52

COVID-19 COVID-19 Vaccine Pharmaceutical Industry FDA 52

Dot Compliance

FEBRUARY 1, 2022

The global pharmaceutical industry has seen its share of challenges in recent years, from manufacturing and supply chain bottlenecks to growing demand for faster delivery of drugs to the marketplace. The post Future Trends and Regulatory Challenges in Pharma appeared first on Dot Compliance. Data in the regulatory spotlight.

COVID-19 Vaccine 52

COVID-19 Vaccine FDA Pharmaceutical Industry COVID-19 52

SQA

AUGUST 2, 2021

This technical report focuses on the challenges facing the pharmaceutical industry that use complex packaging systems for sterile drugs and biologics (e.g., Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

APRIL 12, 2023

The ISPE APQ Guide: Cultural Excellence is the fifth and final guide in the series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance. United States Food and Drug Administration (FDA) – Recalls Hospira, Inc. It is a valuable companion to this APQ Guide. and 225.165).

FDA 40

FDA Compliance Pharmaceutical Industry 40

Hall Render

FEBRUARY 18, 2022

Meet new FDA chief Dr. Robert Califf: 5 things to know. Only 14% of Hospitals Met Price Transparency Rule Compliance. Outpatient push being felt in architecture industry. Bill on prescription drug pricing inspires support from Maine residents, opposition from pharmaceutical industry.

COVID-19 40

COVID-19 Nursing Homes Nurses COVID-19 Vaccine 40

SQA

JULY 8, 2022

88, Microbial Data Deviation Investigations in the Pharmaceutical Industry, January 2022. Food and Drug Administration (FDA) and product manufacturers are aware that it may be present in food and drug products at trace levels, and those very low levels do not pose a safety concern for consumers. PDA Technical Report No.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies.

FDA 52

FDA Compliance COVID-19 Public Health 52