EVENT IS OVER

Contract Manufacturing Organizations Quality Agreements-Online Webinar

Tuesday, Apr 11, 2017 at 10:00AM - 1:00PM
Fremont, CA

Event Details

Description
This Webinar presentation will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective.

Control of suppliers such as Contract Manufacturing Organizations has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents; the expectation is that there will be a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO.

Each proposed section of a Quality Agreement is fully analyzed and suggested content is written with the new guidelines taken into consideration. Comparison of the two regulatory documents is presented with differences highlighted and discussed. Detailed discussion of Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. is covered. The new finalized FDA guidance (Nov 2016) is discussed and a review of comments from industry is included.

Objectives of the Presentation
  • The Who and What of a good Quality Agreement
  • What a Quality Agreement is - and is not
  • Responsibilities of the owner vs. contract facility
  • GMP responsibilities
  • A comparison of the new guidelines from the FDA and the EU
Why Should you Attend
In 2010, the global CMO market was estimated at $26 billion dollars. Year on year growth has been 10.7% since 2008. The increasing use of outsourcing in the pharmaceutical industry along with recent well publicized quality issues with CMOs, make it a necessity to have excellent quality oversight of external manufacturers to provide assurance of GMP compliance. A Quality Agreement is one tool used to accomplish this objective.

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.

Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:
    - EU GMP Chapter 7 "Outsourced Activities" (Revised)
    - Guidance for Industry - "Contract Manufacturing Arrangements for Drugs: Quality Agreements" Nov 2016
Who will Benefit
This webinar will provide valuable assistance to all personnel in:
  • Quality Assurance
  • External Manufacturing / Outsourcing
  • Quality Auditing
  • Technology Transfer
  • Regulatory Affairs / Compliance
  • Supply Chain
  • Purchasing & Risk Management.


For Registration
http://onlinecompliancepanel.com/webinar/CMO-SUPPLIER-QUALITY-AGREEMENTS-503052/APRIL-2017-ES-EZEVENT

Note: Use Promo code DE5YU and get 10% off on registration (Valid till APRIL 30th 2017)

Organization Details

Online Compliance Panel (OCP) creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. OCP largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. OCP believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. OCP closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

Online Event
38780 Tyson Lane, Apt 210
Fremont, CA 94536

Starts April 11, 2017 at 10:00AM - 1:00PM

Add to my calendar  

Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896