Strategic portfolio planning is crucial for developing long-term company strategy. The goal is to meet strategic objectives selecting the "best" portfolio of internal and external drug development programs for funding and balance company resources including money, manpower and manufacturing capacity. Projects could be interdependent, have multiple development scenarios, and are subject to multiple business rules specific for the company environment. Value of each project depends on multiple factors, and could be quantitative or qualitative. Strategic portfolio planning should be based on robust data collection processes. During the webinar we will discuss what data we need, and how to derive them.…

This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. It will examine the broad range of issues to be considered by a company when reviewing 1) A series of minor changes or 2) One major change to an existing product having an existing 510(k), for the need for a new 510(k). Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations…

This webinar will examine the FDA's recently instituted annual "Strategic Priorities" initiative, with emphasis on 2012. Such a review will focus on the broad range of issues a company's senior management and QA/RA need to consider in their annual Management Review of their existing quality management system. This review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what the FDA and industry need to do internally. An additional review of recent information from the Agency, other goals of the Agency…

Statistical Applications includes topics related to basic statistical applications and advanced statistical applications such as statistical process controls (SPC). Includes elements of central tendency, dispersion, proportions and percentages, probability, capability, control limits, specifications limits and more. Why you should attend: To learn of many different areas of basic and statistical process controls applications such as central tendency, dispersion, proportions and percentages, graphical and normal distributions, control limits, specification limits, process capability and more. Areas Covered in the Session: Basic Statistics - Central tendency Basic Statistics - Dispersion Basic Statistics - Proportions and Percentages Basic Statistics - Graphical displays and Normal…

There is a need to implement an adequate formal level of change control during engineering projects (referred to as an Engineering Change Control) after the approval of the equipment/systems specifications in addition to the more formal change control after the qualification of these systems. The Engineering change control process will apply through design, construction and qualification up to the point that the system is considered installed/operational. The new Quality Systems guideline from the FDA states that the Quality function must be involved in the review of the design and subsequent changes to the design of facilities, equipment and systems that…

IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology. This new philosophy has been difficult for test houses and compliance bodies to absorb and develop test strategies. Currently, the EU and Canada have announced May 31-June 1, 2012 as the date when the Second Edition will be withdrawn. Devices that will be released after that date must meet the requirements of the Third Edition. Manufacturers with products under development must start now to develop compliance strategies. The first step will be understanding the…

In order to proactively address areas of concern to the FDA and other regulators, All units within each pharmaceutical firm should review recent regulatory observations and proactively establish programs or systems to address the regulatory concerns. In this webinar we will focus on the laboratory and recent FDA laboratory based operations. We will review observations, identify the real issue and suggest actions to prevent similar observations in other laboratories. Why you should attend: An FDA 483 observation can have an impact on any unit within a firm and laboratories have received more than their share. Since the early 1990s, the…

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs. Areas Covered in the Session: Develop spreadsheet applications that are GxP compliant. Avoid 483s and warning letters. What does and does not need to be validated. Learn how to use Excel’s…

The markedly increased risk of diabetes and cardiovascular disease (CVD) underlines the importance of this metabolic syndrome congress. Discover pioneering research and explore the latest issues from gut hormones in obesity; GLP-1 mimetics and DPP-4 inhibitors in early diabetes and the metabolic syndrome; the role of the GLP-1 axis in prevention, cardiovascular health and cognition; and lessons from bariatric surgery and interventional diabetology. Learn from world leaders, network with fellow specialist, and enjoy the beautiful, historic setting of Vienna.

The British Gynaecological Cancer Society Meeting 2012 (BGCS 2012) is being held in London in conjunction with the National Cancer Research Institute and takes place in London on the 5th and 6th of July, 2012. This is the only BGCS Scientific Meeting for 2012. The programme includes challenging topics for surgeons, oncologists, pathologists, radiologists and nurses. Joining with the NCRI means we have the pick of the top scientists from the UK to present at the meeting. We also have top International speakers from Europe and North America.

Why you should attend: The world is experiencing increasingly dysfunctional outcomes within end-to-end supply chains for pharmaceutical products. In response, FDA and regulators globally have placed improvement in supply chain integrity and product quality as an urgent priority. Key to meeting the rapidly escalating regulatory expectations is effective management of uncertainty and the associated risk of supply chain failure. Risk offers itself in many guises, for example, quality issues with a raw material that lead to product shortages, theft or counterfeiting of high value products and economically motivated adulteration of materials leading to patient death (eg Heparin, 2008). The over-riding…

This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process Qualification and the Continued Process Verification. For each stage, the discussion will focus on the procedures, documentation and statistical tools that should be used to effectively complete each task. In particular, the new definition requires the collection and evaluation of data to demonstrate that the process is capable to consistently meet the pre-defined specifications. For that purpose, the tools selected to evaluate the collected data are key elements in complying with…

Why you should attend: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses adequate investigation of deviations. Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. The investigation of deviations is clearly a US FDA expectation. The international regulatory expectation for a structured approach to investigations…

This webinar will provide valuable guidance to personnel in regulated companies who are in roles viewed as merely support to those in formal leadership positions. Keys to develop credibility. Become a "go to" resource. Break out of the typical staff support mind set and reduce frustration. Play a more proactive role in product development, process implementation, project management planning, and corporate culture change. Enhance existing responsibilities in regulatory compliance, audit response, proof of cGMP "progress against plan", and other regulated activities requiring a planned documented rationale. Common tools for increased credibility will be discussed. Simple approaches using common Excel- or…

Much attention has been paid to the regulatory requirements of reprocessing SINGLE use devices. However, there is increasing attention being directed towards reprocessing REUSABLE medical devices and regulatory requirements. The purpose of this seminar is to explain the rationale, the legal requirements and some methods commonly used for reprocessing & validating reusable medical devices. Why should you attend: Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility in almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you…

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lies in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files) which allow suppliers to protect their confidential product and process information from each and every…

This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice is, what needs to be documented, why it is documented, and FDA expectations for documentation. The webinar explores what the GxP regulations and guidance's say about Good Documentation Practice. Examples of both good and poor documentation are given and exercises demonstrate both good and poor practices. Why you should attend: In today's strict regulatory environment it is more important than ever for companies and individuals to understand and practice good documentation…

Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. These actions may be as simple as a rationale for release to as complicated as the need for the qualification of a new sterilization process. How to decide the course to take will be addressed along with the reasons behind the decisions so that an accurate and complete justification of your decision can be made for both management and regulatory agencies. The…

This webinar will use many graphics to explain its important points. Why should you attend: This course will help you understand your responsibilities when outsourcing so that the product maintains its integrity and quality and satisfies customer and user requirements. The FDA is closely scrutinizing these activities to assure that responsibilities outlined in the regulations and guidance is clearly defined between the contractor and its client. These industry requirements are given in CFR Part 211.22(a), ICH Q7A 2.22-8, ICH Q7A 16, ICH-Q10 and Part 820, Subpart E. The FDA has begun to more closely scrutinize the control of outsourcing because…

This presentation will help you to understand the last changes that occurred in Canadian ethics regulations. The presentation will clarify for sites and sponsors how to easy the ethics process and how to get more quicker the ethics approval. Also after the presentation the participant will understand how to apply the last changes in ethics regulation in the day-to-day work. Every member of the study team and site staff participating in the clinical trial plays an important key role. Knowledge of ethics regulations will ensure quicker ethics approval, no audit findings, speeds up the process for new drugs approval and…