The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pharmaceutical regulatory authorities have. Enforcement penalties can be severe from a business standpoint, and in extreme cases can even impact individuals who are held responsible for the occurrence of data integrity problems. In recent months the topic of data integrity has been in the forefront of concern among worldwide pharmaceutical regulatory agencies. The FDA, EMA, TGA and others have published guidelines setting forth their requirements and expectations for the maintenance of data integrity, as has at least one leading industry organization (PDA).
Disruptive activity by practitioners in the hospital takes many forms. When it happens, it is important that the hospital and/or the medical staff take appropriate steps to see that it does not affect patient care or disrupt operations.
Why should you Attend: Hospital executives, medical staff officers, and peer review committee members and support staff should attend to learn how to deal effectively with the disruptive practitioner.
You will also learn how to prepare for the day when it becomes necessary to terminate such a practitioner's privileges and medical staff membership.
You will also gain an understanding of how to develop provisions in the medical staff bylaws to deal with the disruptive practitioner and how to develop a clear and concise policy regarding disruptive behavior.
Learning how to efficiently use Excel is so critical in many of today's office jobs. Many people know the Excel basics. This webinar will show you how to use the tools sort and filter in Excel,and subtotals to really help get the most out of your data, be more efficient, and find the information that you are looking for.
Why should you Attend
Attend the webinar if you are using MS Office in a business or educational setting to create reports and presentations.
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.
Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge and understanding about how variation in process parameters explains variation in the product quality characteristics of the product.
The use of DOE methodology provides a means to identify process parameters which impact product quality (critical process parameters) and determine the functional relationship that links the process parameters to those critical quality attributes. Screening designs, such as 2k factorial and D-optimal designs, are used to determine critical process parameters.
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The Purpose of this Course is to Review ICH Q10, which is a Document developed by the 3 Countries Comprising ICH (Us, Eu, Japan). ICH Q10 is for the Development of a Pharmaceutical Quality System, In Conjunction with the Companion Documents, ICH Q8, Pharmaceutical Development and ICH Q9, Quality Risk Management. In Addition to the Members of ICH (Us, Eu And Japan), Many Other Groups were involved in the Expert Working Committees that were involved in the Development of these Documents, Etc
Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901546SEMINAR?trainingregistry-April-2018-SEO
In this session Mr. Wolfe will provide a straight-forward, practical explanation of developing concepts, including the quality and value metrics into new federal health care programs and commercial payment systems, new delivery models, what providers can be doing to develop a value-based strategy, and the application of the Stark Law and other fraud and abuse laws to new models aimed at population health, quality of care and cost control.
Mastering these concepts will be a must for health care executives looking to position their organizations for success in this new value-based world.
This session will discuss key strategies to develop a targeted regulatory strategy for managing an effective product development program. The session will provide tips on team building, creating product development plans, choosing your regulatory pathway, regulatory authority interactions, and partnership strategies, while also including case studies to illustrate how these tips can prevent common pitfalls and lead to success.
Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. A HIPAA Risk Management plan is your overall policies and procedures manual.
If audited or the subject of a compliance review you will be required to show the government you have all the necessary policy and procedure documentation in place to address all the required safeguards.
Several of the recent Stark Law cases and settlements have highlighted the risks of acquiring physician practices.
In this webinar, Mr. Wolfe will discuss why these contracts must satisfy a Stark Law exception, and why compensation paid under the acquisition and in the post-transaction services arrangement must both be at fair market value and on terms that are commercial reasonable.
He will also discuss key features of effective and defensible contracts. The webinar will include practical strategies that health care executives can use to enhance the defensibility of these arrangements, including potential features of an organizational policy.
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".
This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?
Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.
This webinar offers guidance to build and maintain a systematic, affordable marketing effort to meet the needs of your organization within budgetary restraints, Also attendees will learn how to hire the right vendors, consultants, or develop staff internally for sustainable results.
Diversity and inclusion are common buzzwords these days but few understand what they really mean or entail. In this webinar, we will explore what diversity and inclusion REALLY are as well as common myths and misconceptions.
We will discuss everything from implicit and explicit bias, diversity in areas you haven't thought of, intent vs. impact, and calling in vs. calling out and more.
This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this seminar is for you.
We'll discuss regulatory requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls. We'll discuss best practices so you can start off on the right foot and always be prepared for an inspection.
In this session Mr. Wolfe will provide practical guidance regarding physician employment contracts, including key regulatory requirements, key provisions and common compensation and common compensation models.
Drug dissolution testing is an essential and critical step for appropriate and efficient product development such as tablet and capsule. A number of approaches are used to conduct dissolution testing using different apparatuses and methods. Making a choice for an appropriate apparatus and method has always been confusing and challenging. This seminar will provide relevant pharmacokinetics and physiological background so that making this choice becomes easier and instinctive. No prior knowledge of pharmacokinetic and/or physiology is required; however, these will be explained in very simple terms to help attendees in selecting or developing a dissolution method. This seminar will describe in detail the theoretical aspect of the drug dissolution testing including method development. Pros and cons of different approaches will be explained in detail.
Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901306SEMINAR?trainingregistry-December-2017-SEO
In January 2006, FDA issued a final rule which specified that most pharmaceutical products (including biologics) produced for use in Phase I clinical trial studies were exempted from complying with GMP requirements, as defined in 21 CFR Part 211 under 21 CFR 210.2(c). Section 501(a)(2)(B) of the FD&C Act requires drugs, including IND products, to comply with cGMPs or if they are not manufactured in compliance with cGMPs, they are deemed adulterated. Based on this statutory requirement for manufacturers to follow GMPs, FDA issued cGMP regulations for drug and biological products in the Code of Federal Regulations (in 21 CFR parts 210 and 211).
Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901549SEMINAR?trainingregistry-March-2018-SEO
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.
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Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
This webinar will analyze each of these necessary elements of the batch record review process.