This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend. Regardless of job titles, risk management is a shared responsibility by all managers. Compared to accounting, risk is an immature discipline with a variety of risk frameworks competing to dominate. Based on the new Wiley and Sons book, Essentials of Risk Management, due for publication at the end of 2010, this webinar is designed to provide a non-math introduction to an area and discipline that is changing rapidly, especially in the light of the risk management failures that have…

As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not Followed" (PNF), that could result in a failure to determine safety and effectiveness. That is why eligibility criteria are so strict, and why any PNF or unexpected events need to be reported immediately. Principal investigators in clinical trials are expected to adhere to the study protocol. Instances of “Protocol Not Followed” (PNF) are not addressed in the CFR or other regulatory rules. The various terms…

Cell banking assures that an adequate supply of equivalent well-characterized cells exist for production over the expected lifetime of the biopharmaceutical. Cell line development followed by preparation of the master/working cell banks is an expensive process and needs to be done right the first time. Cell banks acceptable for early clinical trial material production have been found not to be adequate and appropriate for commercial production, causing product approval delays and rejections. Why should you attend: 'Secret', according to Merriam-Webster's dictionary, is 'something kept hidden or unexplained.' A variety of reasons why an effective Chemistry Manufacturing & Controls (CMC) regulatory…

This course will describe how to assess and optimize pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include recognizing the need to conduct process analysis, developing and prioritizing project portfolio, performing the analysis, and finally implementing the findings. The methodology has helped companies increase compliance at reduced cost. The scope covers all pharmacovigilance activities: case processing activities such as case intake, data entry, assessment and reporting and signaling activities such as signal detection, evaluation and risk management. Why should you attend: Cost Issues: * Blockbuster drugs…

This training entitled "How to Survive a DEA Audi or FIND=FINE" will cover all the record-keeping and security requirements that a DEA registered pharmacy must comply with when handling controlled substances and regulated chemicals. It covers all elements of what occurs during an unannounced DEA Diversion inspection and the auditing of all controlled substances and regulated chemicals. Why should you attend: When DEA Diversion personnel conducts an unannounced inspection of a pharmacy to perform an audit, they generally do not inform the DEA registrant on what steps will be taken during the inspection. In some cases, the pharmacist is not…

The FDA regulations contain a vast quantity of requirements, which govern tasks performed by your company’s personnel every day. Are there going to be noncompliance? You bet. Are you going to correct these noncompliances? Only if you identify them. To ensure substantial compliance, your company needs an effective audit program for both internal and external processes. To have an effective audit program, your company needs an effective audit team. This session will detail the best methods or training auditors, and include the best methods for performing internal audits as well as audits of suppliers and subcontractors. Areas Covered in the…

Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes…

This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining ongoing compliance will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for their clinical studies. Areas Covered in the Session: * Discuss the FDA's role…

The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control. However, the arrival of an investigator for an inspection can still be an intimidating experience. The inspection can be less traumatic if the site and its personnel are properly prepared for the inspection and the investigator. During this hour presentation,…

One of the most common reasons noted by the FDA for recalls of medical device is improper validation. It is also one of the most common reasons companies receive 483s and warning letters. Conversely, successful validations not only satisfy compliance and regulatory requirements, they also provide for robust manufacturing processes satisfying the needs of many individual functions within your organization How do we get there? After we have a clear understanding of the regulatory intent of validation, the key for a robust process validation is the use of six sigma techniques and risk management. The rigor of a validation should…

In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn't introduce any new requirements but only clarifications to the existing requirements. One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization's responsibility for conformity to all customer, regulatory, and statutory requirements. The changes reinforce the need for control over outsourced processes and recommend using the methods found in the ISO 9001 Purchasing clause. These changes also include suppliers who are part of the same parent organization, such as a separate department or…

Many leading organizations have recognized the need to manage environmental risks and demonstrate a commitment to sustainability and related environmental compliance. The pressure to do so is unrelenting in the United States and European Union where children and young adults are committed to the green/sustainable revolution. This mindset is bound to expand to the rest of the world. In the West, there is no going back to the times of industrialization without regard to environmental issues. Countries like China that have been obsessed with industrial expansion regardless of the environmental consequences are likely to modify their behavior to support sustainably…

A good specification not only defines the product and process being purchased by the customer, but also serves as an extension of the purchasing contract. Specifications are customers greatest tool for ensuring products received meet the quality and safety standards expected. Good specifications must be complete and accurate. All requirements must be contained within the specification. Shipping, receiving expectations, prerequisite quality programs, packaging guidelines and any other requirements should be detailed in the specification. Accuracy is the second attribute critical to a product specification. The supplier must have processes, programs and materials capable of meeting the specification and the resultant…

Ready for Inspection by Hamburg's FDA? Under Commissioner Hamburg's new enforcement policy, FDA has issued more warning letters more quickly than it has in years. In some cases, the agency has even skipped warnings and gone straight from inspectional observations to injunctions and seizures. Clearly, the stakes will be higher at your next inspection. The question is: What steps should you take now to be ready for it? The key to effective management of regulatory inspections is effective preparation. Being well organized and confident during the inspection means that your firm gives it's best possible performance which in turn gives…

This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented. Major modules of a DHF SOP and a TF / DD SOP will be presented and discussed -- the webinar will address the development of a new, or revision of an existing DHF SOP and TF / DD to ensure they meet regulatory expectations and assist those charged with compiling, updating…

Drafting claims where you "walk the line" between cosmetic and drug claims is an art with little existing practical guidance. Although different experts can disagree about a particular claim, the labeling regulations are based on a strong regulatory foundation. After a discussion of pertinent U.S. laws and regulations, we extensively examine actual claims and determine whether they cross the line We will each examine claims to better understand the cosmetic/cosmeceutical interface. It will be fast paced but fun! Then, you will have a chance to ask questions about the presentation and related issues. By the end of the presentation, you…

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. An approved…

This presentation will provide auditors who are not knowledgeable about computer system validation with a basic understanding of the requirements and expectations for validation documentation. We will address the basic components of computer system validation, the importance of assessing the quality of such validations performed by vendors, suggested procedures for reviewing validation documentation to ensure a meaningful review in a limited period of time, and how to establish reasonable remedial actions in the case of inadequate validation documentation. Auditing CSV materials is an important element in most audits of CROs, technical service providers (TSPs), and application hosting organizations. Attendees should…

As the industry is moving towards applying Quality by Design (QbD) to process development, the question must be asked: Is this also the way forward to revolutionise, improve and standardise our approach to method development and qualification? The pharmaceutical industry has traditionally controlled analytical methods via a well defined sequence of development, validation and transfer exercises in line with agreed standards such as the quality guidelines ICH Q2. Such an approach limits the scope for technological innovation or improvements in quality or efficiency of methods for established products. Applying QbD would enable enhanced method understanding, and a more systematic and…

The Commissioner of the US FDA has stated the agency will be more enforcement oriented and quicker to issue Warning Letters. This presentation will review current enforcement practices of the US FDA with actual Warning Letters recently issued to medical device companies. We will explore how the company failed to meet FDA expectations in response to inspection and other violations. In the presentation we will attempt to determine what response by the manufacturer may have prevented the issuance of the Warning Letter. We will look at improvements to the Quality System as well as responses to the FDA-483 that was…