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

Healthcare Compliance Professional Courses @ 10$ from GlobalCompliancePanel

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Healthcare professionals now have a stronger reason than ever before to enroll for professional learning courses and upgrade their knowledge. GlobalCompliancePanel, a highly reputable provider of professional trainings for all the areas of regulatory compliance, will offer a pick of their healthcare compliance courses for just $10.

Healthcare professionals have always been flocking to GlobalCompliancePanel to partake of professional trainings courses that are valuable, relevant and highly interesting. They will now have more reasons for doing so and join thousands of healthcare regulatory professionals who have already benefited from GlobalCompliancePanel’s professional trainings, because it is not every day that one comes across an offer in which the professional gets to pay a mere 5% of the original price of the webinars!

These recorded webinars are on a number of topics concerning healthcare. Healthcare professionals can use these courses to augment the learning they have gained over the years and climb up in their professions with even greater ease. What’s more; healthcare professionals have such a huge number and variety of courses to choose from that they can opt for several courses of relevance to them without burning a hole in the pocket.

Why is GlobalCompliancePanel doing this? Simple: It wants more and more healthcare professionals to take up courses that are relevant and valuable to them, so that the knowledge needed for becoming successful in their careers spreads wider and goes deeper. After all, meeting regulatory compliance requirements is the number one challenge for any healthcare professional, who sees no way out of the regulatory maze without the professional trainings needed to understand them. When such a course is available at a throwaway price of $10, isn’t that a delightful thing to have?

Let us feature a couple of the topics on which GlobalCompliancePanel is offering these courses to healthcare regulatory professionals:

The HITECH Acts Impact on HIPAA

HIPAA enforcement is a matter of serious concern to many healthcare professionals. Many of them, even highly experienced ones, are clueless about some of the aspects of this enigmatic law. When HITECH combines with HIPAA; the confusion is doubled. The two laws intersect at many places, thus compounding the complexity of enforcement. This webinar from GlobalCompliancePanel offers clarity and helps them ease the confusion about this law.

Further, the nature and roles of a host of HIPAA-related items such as breach notification, business associate contracts, training of staff and security of PHI for Business Associates can be daunting to understand and implement. Webinars such as this are designed to help healthcare professionals steer clear of the stumbling blocks that they could encounter in implementing these.

Preparing a Medical Product Regulatory Requirement Plan

What happens when healthcare companies fail to meet regulatory requirements set out by the FDA and other regulatory agencies? The consequences are disastrous, and can range from penalties to having their business shut down. One of the foundations to avoiding this sort of situation is to develop a medical product regulatory requirement plan.

A medical product regulatory requirement plan charts out the regulatory requirements  that need to be met from step one, which is quite literally Day One of the start of the process of making healthcare products. A detailed and organized medical product regulatory requirement plan is indispensable to ensuring in the end that the healthcare product meets the regulatory requirements.

It is this priceless learning that this webinar from GlobalCompliancePanel imparts. And yes, at $10!

Drug Safety and Pharmacovigilance

Pharmacovigilance, a crucial area of healthcare, needs to be implemented in full according to the requirements set out in regulations from the FDA, EMA and other regulatory agencies. Drug safety being deeply tied to PV; the proper implementation of the latter is needed to ensure the former.

PV is essentially about ensuring drug safety by implementing measures throughout the process of production. A healthcare company has to comply with directions from a number of regulatory agencies in order to have its products passed by them and to gain permission to enter different markets. They cannot afford to take one wrong step in the whole process. A number of areas such as clinical trials, marketing, disease management and government are just some of the areas in which pharmacovigilance is indispensable.

This webinar from GlobalCompliancePanel is a great means to getting a complete understanding of this intricate topic. The topic is of great relevance to healthcare professionals, but what’s more; it comes at this unbelievable price tag of just $10!

Contact Details:

http://www.globalcompliancepanel.com/webinars_home

John.robinson@globalcompliancepanel.com

Support@globalcompliancepanel.com

+1-800-447-9407

 

Applied Statistics for product and process evaluation in design and manufacturing

Evaluating product and processes is an imperative for almost all design and/or manufacturing companies. These are the reasons for which this evaluation needs to be made:

  • Managing risks
  • Validation of processes
  • Establishing product/process specifications to QC to such specifications
  • Monitoring compliance to such specifications

risk

Lack of proper and thorough grasp of and correct implementation of statistical methods leads a company to having to face significant increases in its complaint rates, scrap rates, and time-to-market. As a result, such companies churn out poor quality in their products, leading to lowered customer satisfaction levels, severely impacting their bottom line.

A learning session to help understand statistical methods

In order to help professionals in process and manufacturing meet challenges associated with statistical methods with greater confidence, GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance areas, is organizing a highly educative two-day seminar on the topic, “Applied Statistics, with Emphasis on Verification, Validation, and Risk Management, in R&D, Manufacturing, and QA/QC”.

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John N. Zorich, Statistical Consultant & Trainer, Ohlone College & SV Polytechnic, will be the Director at this seminar, which has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

To enroll for this seminar, participants can log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900537SEMINAR.

Hands on approach to statistical methods toolbox

The aim of this seminar is to offer a hands-on approach by which the participants could comprehend the ways to interpret and use a standard tool-box of statistical methods that consist of confidence intervals, t-tests, Normal K-tables, Normality tests, confidence/reliability calculations, AQL sampling plans, measurement equipment analysis, and Statistical Process Control.

The Director will equip the seminar delegates with clarity on how to accurately employ and administer statistical methods, which can be used as a launchpad for introducing new products.

medical-device

This two-day session will help participants understand the proper way of avoiding issues relating to these aspects of statistical methods. John will explain how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing by giving real life examples derived mainly from the medical device design/manufacturing industry.

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John will cover the following areas at this seminar:

  • FDA, ISO 9001/13485, and MDD requirements related to statistical methods
  • How to apply statistical methods to manage product-related risks to patient, doctor, and the designing/manufacturing company
  • Design Control processes (verification, validation, risk management, design input)
  • QA/QC processes (sampling plans, monitoring of validated processes, setting of QC specifications, evaluation of measurement equipment)
  • Manufacturing processes (process validation, equipment qualification).