Advarra

SEPTEMBER 8, 2022

One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. In 1997, FDA released regulations providing guidance on the use of electronic systems. Un-specified identified Agency regulations. There are many factors in how Part 11 regulations affect software.

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XTalks

JULY 26, 2024

They ensure efficiency, compliance and profitability. Wherefour , a leader in ERP solutions, is transforming and simplifying how food and beverage companies manage production and compliance. They help manage complex operations, track inventory and ensure regulatory compliance.

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Cloudbyz

MARCH 3, 2023

Regulatory Compliance Compliance with regulatory requirements is critical for CROs. This can make it challenging to ensure compliance with the latest regulations and guidelines. To address this challenge, mid-size CROs should invest in regulatory expertise and keep abreast of the latest regulations and guidelines.

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Cloudbyz

AUGUST 19, 2024

Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?

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FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

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FDA Law Blog

MARCH 2, 2022

By Riëtte van Laack — On February 18, 2022, the US Consumer Product Safety Commission’s (CPSC) Office of Compliance and Field Operations issued a guidance for household substances not intended for household use under the Poison Prevention Packaging Act (PPPA). No, that is not a typo.

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Camargo

NOVEMBER 15, 2021

The guidance aims to address country-specific versus global continuous manufacturing (CM) requirements for any new product and to harmonize global regulations. Batch steps include filter drying, milling, and packaging. Manager, Regulatory Compliance. Co-Authors: Bill Stoltman, JD. Vice President, Regulatory Operations.

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FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.

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Pharma Packaging Solutions

NOVEMBER 11, 2024

By providing all required components in one package, medical device kitting reduces the duration of procedures and improves overall productivity. Medical device kitting promotes standardization by packaging specific components together, ensuring the same tools and supplies are used across different procedures or facilities.

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FDA Law Blog

NOVEMBER 16, 2021

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. Hyman, Phelps & McNamara, P.C. (“HP&M”)

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XTalks

JULY 19, 2024

The term “daily value” is central to understanding the Nutrition Facts label, a staple on nearly every packaged food product in the US since 1994. Packaging also plays a role. The history and implementation of the Nutrition Facts label are more complex than they appear.

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

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Clinical Trial Podcast

FEBRUARY 23, 2021

Rather than letting the clinical site continue enrollment, the PM decides to put the site enrollment on hold until the compliance issues are fully addressed and resolved. The PM anticipates the negative impact of compliance issues on the overall trial. A great project manager would drive to the airport and drop off that package.

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XTalks

JULY 26, 2024

Plastics are ubiquitous in consumer and industrial products, ranging from packaging to automotive parts. Despite concerns, current evidence does not show significant migration of these particles from plastic food packaging into foods and beverages. Understanding their presence and potential impacts is crucial for industry stakeholders.

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FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance. By John W.M. Truly, these are complex considerations.

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ACRP blog

JANUARY 11, 2024

As the saying goes, “With great power comes great responsibility,” and with so many clinical study site leaders now taking technological powers into their hands that were traditionally held by sponsors, some of them and their staff may be surprised to find the awesome responsibilities that come packaged with the deal. View complete schedule.

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XTalks

MAY 9, 2023

As the demand for clinical trials continues to grow, so does the need for skilled professionals who can manage complex trial operations and ensure that studies are conducted in compliance with regulatory requirements. Ensuring compliance with applicable regulations, guidelines and ethical principles.

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Pharma in Brief

DECEMBER 3, 2020

Health Canada has published a proposal titled “ Consultation on amending the Food and Drug Regulations ( FDR ) to expedite access to COVID-19 drugs ”. In the fall of 2021, regulatory amendments to the Medical Device Regulations ( MDR ) are expected take effect and remain in force for 2 years. .

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pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines.

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pharmaphorum

NOVEMBER 24, 2022

While many production environments across all verticals must remain hygienic for product integrity, the standards that regulate pharmaceutical cleanrooms are more stringent – with unique industry-specific standards governing their use. Meeting strict standards. Enter cleanrooms-on-demand…. Solving industry challenges. About the author.

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FDA Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. g)(4) of the California Public Resources Code; or.

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FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

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FDA Law Blog

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. Most of the compliance dates have been passed. By Philip Won & Lisa M.

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pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. Why is guidance needed? What are the rules on Social Media Influencers and Digital Opinion Leaders? About the authors.

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Pharma Marketing Network

AUGUST 9, 2023

The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products.

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Cloudbyz

JANUARY 27, 2021

Understand global regulatory implications Federal laws and regulations heavily govern clinical trials. For example, the regulations for governing trials in the US and EU allow electronic submission of clinical trial reports (with few exceptions), but this might not be the case in other countries. Package Installation.

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FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. requires generally that manufacturing of a combination product (CP) must comply with the applicable current Good Manufacturing Practice regulations (cGMPs) for all of its components ( i.e., a drug/device CP must follow the cGMPs for drugs as well as those for medical devices).

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pharmaphorum

JANUARY 4, 2022

Provided as a cloud or on-premise solution, PRISYM 360 is designed specifically to address the unique complexities of medical device, clinical trial and pharmaceutical labeling and packaging artwork. About PRISYM ID.

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Pharma Marketing Network

DECEMBER 4, 2024

Marketing pharma has become a complex and competitive field, with companies vying for the attention of healthcare providers (HCPs), patients, and regulators alike. From strict regulatory environments to growing patient expectations, the industry requires a delicate balance of innovation and compliance. The good news?

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XTalks

AUGUST 15, 2024

Despite concerns, current evidence does not show significant migration of these particles from plastic food packaging into foods and beverages. They enhance the ability to trace the history, location and application of items, which is vital for quality control and regulatory compliance.

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Cloudbyz

OCTOBER 19, 2023

Regulatory Compliance: Streamlining processes aids in meeting stringent regulatory requirements and maintaining data integrity. Conclusion A unified clinical trial management platform is no longer a luxury but a necessity for pharmaceutical companies aiming to thrive in an increasingly competitive and regulated industry.

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pharmaphorum

AUGUST 16, 2021

Compliance is key. These are now used by several regulatory bodies, including the Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for submission packages. Metadata can also be uploaded into ryze and validated against relevant CDISC standards to ensure compliance.”.

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pharmaphorum

JULY 13, 2021

The regulated content and labeling software firm has made three new customer-facing appointments and created a brand-new Customer Experience Team to provide enhanced, end-to-end customer support for medical device and clinical trial organizations.

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Pharma Business Blog

MARCH 15, 2023

The Clinical Trial Regulation (“CTR”) foresees a transition period from 2022 to 2025, during which all ongoing trials approved under the Clinical Trials Directive will be transitioned to CTIS. • Non compliance with EU/EEA regulations lead to a potential supply chain disruption as well asl re-call of clinical trials material.

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FDA Law Blog

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” See, e.g., 42 CFR § 430.0.

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FDA Law Blog

MARCH 28, 2022

Circuit held that products that simultaneously meet both the FD&C Act’s general “drug” definition and its more-restrictive “device” definition must be classified and regulated as “devices,” FDA issued an “ Immediately in Effect Guidance ” to implement the decision as applied to ophthalmic products.

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Cloudbyz

AUGUST 15, 2024

RTSM systems streamline the logistics of clinical trials by automating key processes, reducing the risk of human error, and ensuring compliance with regulatory standards. Improved Compliance: Ensures adherence to regulatory requirements and trial protocols. Can RTSM systems be used for decentralized or hybrid clinical trials?

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