Biosimilars

FDA Approvals,News, Europe, EC, EMA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

06/22/2020

Short Abstract Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485.

04/15/2020

Equipment Validation, Tracking, Calibration and Preventive Maintenance
Friday, 8th May, 2020 01:00 PM EST 10:00 AM PST
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. However, there are ways to validate equipment already in use!
This webinar will discuss Equipment Calibration Requirements, Preventive Maintenance Requirements, when to use Calibration when to use Maintenance, what is Remedial Action for Out-of-Calibration Equipment, how to use of Calibration Standards to Save Cost.
Areas Covered in the Webinar:
Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification..
Equipment Preventive Maintenance Requirements.
Calibration vs. Maintenance: When to use Which One?
Remedial Action for Out-of-Calibration Equipment.
Use of Calibration Standards to Save Cost.
Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation.

02/25/2020

Best Practices for FDA's Investigating Deviations

Friday, 6th March, 2020 01:00 PM EDT 10:00 AM PDT

This webinar will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills and effective preventative action plans will also be discussed.

The presentation will cover the following areas:
Review of FDA a Regulatory Requirements for Investigations
What is the definition of a Deviation?
Types of Deviations/Identification of Deviations
Conducting the Investigation
Interviews – dos and don’ts
Source Documents/Evidence
Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
Key Elements of the Investigation Report

To participate kindly register on www.biopractice.com or email@marketing@biopractice.com

02/11/2020

A CAPA Primer - Elements of a CAPA Program

Short Abstract
A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program.

Areas Covered in the Session:
QSR and ISO 13485 requirements for CAPA
Elements of a cross-procedural CAPA program
Applications of CAPA
CAPA data and its uses Application of risk management to CAPA program

Key Speaker : Jeff Kasoff, RAC, CQM/OE Quality and Regulatory Affairs Consultant

02/03/2020

Latest Guidelines on ICH GCP R2
on 28th of February 2020 @ 5:00 PM EST .

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that involve the participation of human
subjects. Compliance with this standard provides public assurance that the rights, safety, and
well-being of trial subjects are protected, consistent with the principles that have their origin
in the Declaration of Helsinki, and that the clinical trial data are credible.

The objective of this ICH GCP guidance is to provide a unified standard for the European Union,
Japan, and the United States to facilitate the mutual acceptance of clinical data by the
regulatory authorities in these jurisdictions

02/03/2020

CAPA
Key Element of Quality Management System Compliance ON Friday 28th of Feb 2020 @4:00 PM EST

CAPA is a complete system that collects information regarding existing and potential quality problems.

It analyses and investigates the issues to identify the root cause of nonconformities. CAPA is not just a quick-fix, simple approach.
It is a process and has to be understood throughout organizations.
The CAPA system is second to none in terms of frequency and criticality of its deviations, and most of the regulatory actions taken by the FDA and foreign regulators are linked to inadequate CAPA systems.
Understanding the CAPA system is a fundamental prerequisite to improving it. Investigating and discovering the root cause of any event is just the starting point of the CAPA journey.

12/17/2019

Evaluating Biomarkers During Clinical Trials for Immunotherapies

How biomarker evaluation allows a comprehensive profiling of the tumor and is mandatory to elucidate actionable or resistance mechanisms to treatment in solid cancers. Next, Professor Fabrice Barlesi, Head of Multidisciplinary Oncology and Therapeutic Innovations at APHM, will focus on the choice of relevant immune-related biomarkers to be tested in order to predict and overcome resistance to treatments in patients suffering from lung cancer. The Pioneer Project, supported by the French Research Agency, will illustrate this topic.

How modulation of immune status of tumors during immunotherapies fights cancer cells and the associated mechanisms of action
Why gaining insights in the immune contexture of tumors at baseline and in the course of clinical trials for immunotherapies is crucial for predicting response to treatment and for deciphering mode of action of resistance to treatments
How biomarker evaluation can impact immunotherapy drug development

11/18/2019

How FDA Evaluates Your Quality Management System

Friday, 22nd November, 2019 01:00 PM EST 10:00 AM PST

Once your company has successfully navigated the U.S. device clearance process, a Quality Management System (“QMS”) needs to be implemented before you can start marketing your product. Your QMS must contain all the requirements of FDA’s Quality System Regulations (“QSR”).

QSR imposes many requirements but contain little detail in how to implement them; however, failure to appropriately interpret these requirements could result in significant impact on your company, which may include temporary or permanent removal of your device from the market.

The presentation will cover the following areas:

Introduction to FDA Regulations
Overview of Quality System Regulations (“QSR”)
How FDA Evaluates Your Quality Management System (“QMS”)
Most Inclusive Requirement: Document Control
Most Critical FDA Non-conformances
Most Common FDA Non-conformances

11/11/2019

This webinar provided an overview of biosimilar and interchangeable products and the approval process in the U.S. This webinar also explained the various scientific concepts used in the development of biosimilar products and the FDA's approval standards. In addition, we described some practical information regarding use of these products, such as labeling, terminology, and pharmacy substitution and reviewed the resources available to health care professionals about biosimilar and interchangeable products.

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