Pretreatment technology is quite diverse with many tried-and-true options. This seminar describes and identifies new and innovative technology which can eliminate many traditional pretreatment modules. The new ISO-22519 elucidates on many pretreatment issues which will be discussed. ISO is a voluntary standard which may be instituted by a company and is often quoted or cited by a regulatory agency. This presentation offers ideas, physical modules, and descriptions of alternative pretreatment options.
Attend this webinar to learn how to be fully compliant with the USDA Final Rule on Bioengineered Food Disclosure, disclosure requirements in product labeling; disclosure options available to food manufacturers and distributors; symbols to be used and graphic requirements; and the timelines for compliance.
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
In this training program, attendees will understand when and why to apply DOE (design of experiments). They will also learn to identify and interpret significant factor effects and 2-factor interactions and develop predictive models to explain and optimize process/product behavior. Applying efficient fractional factorial designs in screening experiments will also be discussed.
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
This webinar provides some practical and useful answers to the question: “How Large a Sample Do I Need?” Methods for determining appropriate sample sizes in raw materials acceptance, finished product release, process and product development experimentation and process monitoring for process stability and capability is discussed. A comparison is made of the square root (n)+1 sampling rule with the ANSI Z1.4 sampling system for process monitoring including incoming raw materials, in-process manufacturing and finished product. The value of a systems approach to sampling and practical tips, traps and guideline for sampling is discussed. The presentation includes portable methods for making power calculations for experimental design. The concepts and methods involved are introduced and illustrated with pharmaceutical and biotech case studies and examples.
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
FDA regulates how firms advertise and promote their products in social media. It creates a regulatory risk for enforcement action when firm’s step over FDA’s somewhat mysterious advertising and promotion boundaries. What you or someone else says about your product, whether true, false or misleading, becomes a target for FDA’s legal hammer. FDA can levy fines or issue Warning Letters. Even an injunction or prosecution may end up creating a corporate crisis and confusing your customers and drive them away.
This webinar will discuss how to use tiered approaches to evaluate the benefits and risks of novel nanomaterials and product formulations containing nanomaterials, as well as common risk mitigation approaches.
This webinar will help you understand the requirements of the new medical device regulation EU MDR 745/2017 and teach you how to create the reports. The understanding of the changes and how to implement last-minute changes until May 2020 is essential to keep your certificates and to sell your products after May 2020 to the European Union.
This webinar will review the global regulations pertaining to spices, herbs and their extracts used for flavors as well as an overview of all flavor regulations. It will also go into detail about spice/herb as well as flavor guidance documents from trade organizations, international & regional regulatory bodies and specific country regulations.
This process capability analysis webinar will discuss the relationship between variation and accuracy, and process yield, short term versus long term variation, non-normal distributions and how to perform a process capability study.
Attend this webinar to explore some of the common sponsor errors. Become aware of the risk and liability of these decisions. Learn how to get approvals of submission, prevent enforcement actions, and loss.
This webinar is intended for the pharmaceutical industry and associated service providers. It will provide pharmacovigilance and quality assurance departments with an overview of regulatory requirements and expectations for Good Pharmacovigilance Practice audit programmes, with a focus on auditing of activities internal to an organisation as well as those contracted out to service providers and commercial partners, such as distributors and licence partners.
So, we perform Management Reviews because FDA regulations require it? In fact, if you are performing management reviews only to satisfy FDA, you may be complying but you are probably wasting your time. Effective management reviews should have tangible value to the senior executives performing the review. In this online training, we will review how to perform effective management reviews that will assist in the effective management of the company.
Discharge planning has become more than just the movement of the patient out of the hospital. It is a “process” that starts at the point of admission and follows the patient beyond discharge. The Centers for Medicare and Medicaid Services (CMS) have recently added more “teeth” to the process as it is outlined in the Conditions of Participation for Discharge Planning. Discharge planning is no longer a destination but a process that starts before the patient is admitted to the hospital and continues after they are discharged.
CMS has changes to evaluation management coding for 2020 and 2021. The 2020 changes are significant and include new services and expansion of existing services. The changes finalized for 2021 include major changes to the physician requirements for documentation related to evaluation management coding.
This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-of-the-Art Library for your medical device portfolio.
This training program will list and enumerate relevant laws, regulations and standards required for health equity and patient-centered care of LGBT patients. It will discuss opportunities to collect LGBT–relevant data and information during the healthcare encounter and help chart strategic community outreach efforts to the LGBT population.
This course will describe the Medicare Coverage Analysis (MCA) process and the revenue cycle’s uses for this document. The course will describe the creation of the MCA and the multiple uses for this document.