BioPractice

05/14/2020

Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

Friday, 22nd May, 2020 01:00 PM EST 10:00 AM PST

As regulations change and become more stringent, one aspect of compliance has not changed, and that is ensuring changes, deviations, validations and risk assessments are done properly and have a proper justification and rationale. It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result.

In this webcast, you will learn efficient and complaint ways to justify the validations, changes or deviations in a manner that will explicitly demonstrate to the reader why the process was performed the way it was.

Areas Covered in the Session:

How to propose a solution to the problem related to the deviation, change control, risk assessment or validation study
Determine alternatives or options to the proposed solution
Analyze costs, benefits, impacts, and risks of the proposed solution
Validate the solution, assess product impact to the market
Determine impact to the patient, system or firm as a result of your findings

02/04/2020

E6 R2 ICH GCP GUIDELINES LATEST VERSION

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

12/18/2019

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

12/17/2019

Risk Management in Medical Device Manufacturing

Having an effective risk management process adds value by decreasing the project risks and avoiding costly late-stage changes. Furthermore, a risk management process is also mandated by regulatory authorities in the US through the FDA CFR 21 Part 820, the updated European EU MDR/EU IVDR and the MDSAP, which covers markets such as Canada, Brazil, Australia and Japan.

There are several aspects of implementing an effective risk management process. A recommended first step would be to establish a risk management process including usable and operational templates so that the process complies with ISO 14971:2012 for the European market and ISO 14971:2007 for the rest of the world.

How to improve efficiency in controlling and managing complex data structures
How to secure and improve traceability
How to improve visibility and processes
How to secure a complete audit trail in one system

12/09/2019

Real-Time Premarket Approval Application (PMA) Supplements
Friday, 15th November, 2019 01:00 PM IST 10:00 AM PST

An approved Premarket Approval Application (PMA) -- like an approved New Drug Application (NDA) -- is, in effect, a private license granted to the applicant for marketing a particular medical device. Premarket approval requirements apply differently to preamendments devices, postamendments devices.

• History of PMA regulations.
• When to file a PMA.
• Who must file a PMA .
• Preamendments devices and PMA requirements.
• Types of PMA submissions.
• Contents of a PMA.
• PMA review process.
• PMA user fees, review times, review trends
• Pitfalls and common mistakes
• Resources for more information

For More Information Kindly visit www.biopractice.com.
Write to us at marketing@biopractice.com
We are available 24x7 at 1- 646-216-8860

11/07/2019

Live Session on Friday, 15th November, 2019 01:00 PM IST 10:00 AM PST

Real-Time Premarket Approval Application (PMA) Supplements
Friday, 15th November, 2019 01:00 PM IST 10:00 AM PST

An approved Premarket Approval Application (PMA) -- like an approved New Drug Application (NDA) -- is, in effect, a private license granted to the applicant for marketing a particular medical device. Premarket approval requirements apply differently to preamendments devices, postamendments devices.

• History of PMA regulations.
• When to file a PMA.
• Who must file a PMA .
• Preamendments devices and PMA requirements.
• Types of PMA submissions.
• Contents of a PMA.
• PMA review process.
• PMA user fees, review times, review trends
• Pitfalls and common mistakes
• Resources for more information

For More Information Kindly visit www.biopractice.com.
Write to us at marketing@biopractice.com
We are available 24x7 at 1- 646-216-8860

08/14/2018

21CFR Records # FDA regulation # QUALITY #

21 CFR Part 11 Conformance for Medical Devices

Friday, 17th August, 2018 01:00 PM EST 10:00 AM PST

Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will explain what all this means. A 21CFR checklist and a Test protocol form will be given as handouts

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained.

The presentation will cover the following areas:

Patient Safety

How to Prevent Electronic Records

How 21 CFR part 11 considers both data security and patient safety.

The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained.

Our Objective is to leverage Knowledge & Expertise of highly skilled professionals in the field of B

05/21/2017

05/18/2017

Clinical Development Plans and Target Product Profiles, including: assisting with selection of --cli

05/15/2017

FDA Import Requirements

11/10/2016

Navigating FDA Import Requirements for Food, Devices, Drugs and other FDA Regulated Products
Short Abstract
Navigating FDA’s requirements in order to successfully import FDA regulated products is important for any company that relies on sales revenue from foreign made products regulated by FDA. In order to assure that the imported product does not get detained or refused entry the importer should be fully informed of FDA requirements for foods, medicines, medical devices, cosmetics, and radiation emitting devices. In addition there are requirements for general importation enforced by the Customs and Border Protection (CPB) section of the Department of Homeland Security.

During this course we will provide information on FDA’s authority and the requirements for FDA regulated products.

What can happen if you are not familiar with FDA and/or CPB requirements? You may find that you have purchased a large amount of a foreign made FDA product, which do not meet FDA’s requirements. FDA may refuse entry, or you may incur a long delay in the importation, both of which can be very costly for the importer.

Key goals of the Webinar will include:

Become familiar with the product categories regulated by FDA.
Know how to select foreign suppliers that can provide products that meet FDA requirements
Know the requirements for specific types of FDA regulated products
Become familiar with the procedures FDA follows to process an import entry
Know how to file FDA and CPB entries that will meet the requirements
Know who to negotiate with FDA when an import problem occurs
Know how to train your own employees in FDA/CPB requirements
Attain the ability to have a high level (100%) of success on each import entry.