What Should You Expect from Drafting and the Use of Drug Master Files & Quality Agreements?

Outsourcing is a common practice in the pharma and biological industries. Manufacturers of pharmaceutical and biological products outsource many of their manufacturing processes to contractors/suppliers. This arrangement bestows many benefits for both sides. However, lack of clarity about the terms of the contract can become a cause for contention when there is a disagreement or dispute between the parties. In fact, lack of clarity can be a primary cause for disputes and disagreements.

The root of these problems lies in the inability of the concerned parties to thoroughly and properly delineate roles and responsibilities and set up proper mechanisms for the resolution of these issues when signing agreements. One of the crucial areas of the agreement pertains to the development, support and updating of confidential Technical Files (Drug Master files). Drug Master Files are documents which allow suppliers to protect their confidential product and process information from each and every customer, which they share with only the regulatory agencies.

Full understanding of Quality Agreements and DMFs 

So, a clear understanding of what the regulatory agencies around the world look for in the DMFs is imperative for suppliers to ensure that their agreements with contractors/suppliers are drafted and implemented without any misunderstanding. Quality Agreements and Drug Master Files, which are at the core of these arrangements, need to be drafted thoroughly. To do this, a complete understanding of the rationale behind the Quality Agreement and the Drug Master Files is a must. This is exactly what a seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.

Technical Writing for the Pharma, Device and Biotech Industries 3

This two-day, in person seminar will have Robert J. Russell, President/CEO of RJR Consulting, Inc., as Director. RJR Consulting specializes in helping clients navigate through global regulatory compliance requirements for pharmaceuticals, medical devices, biologics, combination products and dietary supplement/OTC products. Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization/registration preparation, and meet variations/amendment filing responsibilities and license renewal filings.

understanding of Quality Agreements and Drug Master Files

How DMFs are viewed by the different regulatory agencies

Aimed at professionals involved in the areas relating to pharmaceutical, biologic and medical device products, components, and packaging materials, such as manufacturing, Regulatory Affairs, project management, global supply chain, research and development, Quality Assurance and control, validation, and development, preparation of submission materials and General Management; this course will describe the current review and enforcement environment within FDA, as well as the manner in which Drug Master Files (DMFs) are reviewed by the agency.

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

Bob will also familiarize participants with the use of DMFs in the EU, Japan, Canada and Australia, during which he will highlight both the similarities and differences these countries’ regulatory requirements have to the U.S. system.

The important learning objective this course will impart is a grasp of how to prepare Quality Agreements and Drug Master Files (DMFs) with the FDA, with an understanding of the rationale behind doing so. Practical knowledge of what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and the strategies for avoiding the most common DMF-related errors are the other important learning outcomes of this course.

Bob will also explain how DMFs are organic by their nature, and will present strategies for establishing and maintaining effective change control programs. He will also show how to facilitate effective communications with regulatory agencies along with customers and vendors.

Of late, the FDA has been transitioning from a paper filing system to electronic submissions for initial DMF submissions, annual updates and DMF amendments. Bob will discuss this development as well.

Enhance Your global visibility with GlobalCompliancePanel Seminar Sponsorships

Process Development and Validation rest on the right Design of Experiments and Statistical Process Control

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The application of DOE and SPC to the development, design and monitoring of manufacturing and testing requires the use of procedures. Why? It is because in a recent guidance document on Process Validation, the FDA has named the Quality Unit as being responsible in the review and interpretation of DOE and SPC studies.

The Quality Unit needs to take a practical orientation when it sets out doing this work. An approach in which case studies and examples are sprinkled goes a long way in helping Process Validation professionals in their work. This is exactly what a seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will offer and help regulatory professionals in the Quality Control and Quality Assurance areas achieve their aims.

The Director of this two-day seminar is Dr. Steven Kuwahara, who Founder and Principal, GXP BioTechnology LLC. Want to understand ways by which to adapt the right approach to applying DoE and SPC to the development, design and monitoring of manufacturing and testing? Then, please register for this very useful session by logging on to Process Development and Validation rest on the right Design of Experiments and Statistical Process Control . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Completely interactive

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Dr. Kuwahara will do full justice to the role and importance of practical experiments in aiding an understanding of Design of Experiments. Theoretical information will be given only when it is needed to help gain an understanding of an experiment. At this highly interactive and practical session, Dr. Kuwahara will offer examples from real processes and testing procedures. He will intersperse these with examples that will be directly applicable to the areas of work that relate to the participants of this seminar.

An understanding of the way the process parameters relate to and work with each other is necessary for any pharmaceutical worker who is involved in performing, supervising or reviewing manufacturing or testing processes. The ability to monitor the performance of processes and test methods is also needed for such a worker. While this is true for a professional in any department of pharmaceuticals; it applies more to the worker who works in Quality Control and Quality Assurance, a requirement that has become necessary following the passage of recent FDA guidance document on Process Validation.

However, it is the development, manufacturing, or quality systems worker who carries out this work. In view of this fact, a high degree of coordination is needed between these two levels of employees. At this seminar, Dr. Kuwahara will arm these two levels of employees with the knowledge of the ways of designing the systems and studies, and then interpreting the results generated.

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Dr. Kuwahara has charted out the following agenda for this seminar:

Dietary Design of Experiments

  • Introduction
  • One Level, One Factor Designs. Simple Comparisons
  • Two-Level Multi-Factorial Design
  • Extracting Information from the Experiment

Statistical Process Control

Design of Experiments and Statistical Process Control

This seminar is designed for the benefit of professionals involved in the procedures and applications of DOE and SPC, such as Directors, Managers, Supervisors, Lead workers in Process Development, Manufacturing, Regulatory Affairs, Quality Assurance and Quality Control, and workers who participate in operations or the are involved in the supervision of the development, manufacturing, or testing of medicinal products.

To join us for more information, get in touch