Requirements for Electronic submission of Drug Master Files-Online Webinar

Tuesday, Apr 11, 2017 at 11:30AM - 2:30PM
Fremont, CA
Item Name Price Each Fee Each Items Left Qty to Buy
Live Session
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$250.00 $8.62 23

Super Combo Offer
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$500.00 $16.34 22

Special Offer
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$625.00 $20.20 10

Corporate Live Session
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$1,250.00 $39.52 20

Event Details

Description
In this webinar, you will learn the required contents of Module 3 as well as the appropriate formatting. Lifecycle management and updating requirements will be discussed, including appropriate change control and sponsor notifications. You will also gain an understanding of contact points with the FDA throughout the lifecycle of the DMF, including information requests and inspections.

Objectives Of The Presentation
  • Manufacturing process development
  • Process controls
  • Selection of starting materials
  • Control strategy
  • Process validation evaluation
  • Submission of information into the DMF, content & format
  • Providing letters of reference to support a sponsor CTD
  • Life cycle management of the DMF
  • Interactions with the FDA throughout the DMF lifecycle
Why Should you Attend
Type 2 DMFs for Active Pharmaceutical Ingredients (APIs) are needed in order to protect confidential information and allow the ability for API manufacturers to sell to multiple customers, while providing and updating their information in only one submission and one format.

Information provided in the DMF must cover all required sections of the International Conference on Harmonization (ICH) CTD guidance document covering the Module 3 drug substance section. This section requires details about the development of the API, raw materials, equipment, formulation, critical attributes, manufacturing process and controls, analytical methods, specifications and stability.

Who will Benefit
This presentation is targeted toward the following organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to manufacturing:
  • Regulatory Affairs
  • Quality Assurance
  • Pharmacovigilance
  • Project Management
  • Regulatory Operations
  • Process Automation Manufacturing Operations
  • Process and Design Engineering
  • Quality Control (Chem and Micro)
  • Utility Operations & Anyone responsible for providing content for the CTD.


For Registration

http://onlinecompliancepanel.com/webinar/DRUG-MASTER-FILES-DMFs-509436/FEBRUARY-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.

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Venue Map (from Google Maps)

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

Starts April 11, 2017 at 11:30AM - 2:30PM

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Contact Information

Organization: Online Compliance Panel LLC

Event Contact: OCP Panel

Phone: 15108575896