PAT (Process Analytical Technology): An FDA and Industry Effort
Nissan Cohen
90 Min
Product Id: 706370
Process Analytical Technology was released by the FDA as a 21st century guideline in September 2004. This guidance was released to help the pharmaceutical industry with real-time release, process understanding, and using the process to ensure all CPPs and CQAs meet compliance, URS, and SOPs. The use of PAT can alleviate strenuous validation procedures by using the process as the function of validation.
Basic Laboratory Skills
Mark Powell
60 Min
Product Id: 706286
Accurate measurement of weight and correct use of volumetric apparatus are prerequisites for valid analytical measurement. This webinar covers the quality-critical aspects of both. It is intended for new starters in industrial analytical laboratories or for other staff who would benefit from refresher training.
Human Centric Change Management
Madonna Swanson
60 Min
Product Id: 706388
Change is difficult. At the core of all change is human nature and human nature is as diverse as each individual. Learn proven techniques that enable your transformation to not only be effective, but embraced by the diverse individuals in your organization.
Food Safety Compliance: Safe Food, Bioengineered Food, Prop 65, Food Microbiology Training Kit
Michael Brodsky,Gina Reo
5 Hrs
Product Id: 706462
Excel Training Kit: 6 Excellent Crash Courses on Microsoft Excel Available in USBs and CDs
Joe Weil,Mike Thomas
8 Hrs
Product Id: 706463
Handling a Chaotic Work Environment: How to Prioritize Work and Make Good Decisions Under Pressure
Christopher R DeVany
90 Min
Product Id: 706342
This highly interactive Webinar offers you and your team an array of practical tools to help you get things done in today's chaotic and constantly changing work environment. You’ll learn practical techniques for making structured decisions—even under pressure—to earn buy-in from bosses, coworkers and customers. In a workshop environment, you will participate in valuable exercises utilizing real-world case studies. You'll emerge with an action plan you can use right away to master expanding workloads and complex decisions.
Effective Vendor Risk Management
Mario Mosse
90 Min
Product Id: 705193
Vendor risk management is an important component of a financial institution’s operational risk management program. This training program will examine how a sound vendor risk management program, including careful planning, due diligence and selection, and close oversight and monitoring during the life of the contract, is necessary to reduce the risks posed by the outsourcing of critical functions.
Cleaning Validation Made Easy : Basic Concepts of Cleaning Validation
Victor Olatundun
60 Min
Product Id: 706346
This webinar will discuss the basic concepts associated with cleaning validation to facilitate the construction of robust cleaning validation program as well as provide a cost-effective approach on conducting cleaning validation.
FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products
Carolyn Troiano
90 Min
Product Id: 705097
This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.
Preventing Harassment, Abusive Behavior, Bullying and Discrimination in the workplace (for staff)
ArLyne Diamond
120 Min
Product Id: 706319
It only takes two people to have a behavior reported as either sexual harassment, bullying, or discrimination. Thus, we strongly recommend that you provide training to all employees at least annually no matter how many you consider your head count. This course is mandatory for managers and supervisors in companies having 50 or 15 or more employees. In California it has now changed to five (5) or more and other states will follow.
Overview of IVD Regulations in the US, EU and Canada
Josh Levin
90 Min
Product Id: 706382
This webinar will present an overview of the regulation of in vitro diagnostic (IVD) devices in the United States, European Union and Canada. With a primary focus on IVD regulation by the US FDA, the webinar will cover the classification of IVD devices, an overview of data required for different submission types, and special topics. The webinar will also cover the changes in regulatory oversight in the European Union, and will briefly touch on the regulation of devices in Canada, including recent changes related to oversight of the quality system in that country.
Sterilization of Pharmaceutical Products and Medical Devices
Carl Patterson
90 Min
Product Id: 705310
This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
Claims Processing: Appropriate Segregation of Charges & Medical Documentation for Clinical Research Studies
Mary Veazie
90 Min
Product Id: 706386
Participation in clinical research activities presents challenges for an already complex revenue cycle and insurance system. The medical documentation needed to ensure reimbursement from third party payors is an essential part of this process. This course will review the segregation process and medical documentation needed to ensure reimbursement is sufficient to obtain reimbursement from third party payors.
Technical and Strategic Considerations in Performing Food Safety Management Systems Sustainment (Session III)
Mike Weber
60 Min
Product Id: 706300
This Webinar, the last in a three-part series, focuses on the methodology behind managing sustainment of Food Safety Management Systems. This includes GFSI standards, USDA-FSIS, FDA Food Code 2017, HACCP, Preventative Controls, and FSMA under the broad umbrella of Food Safety Management Systems. Impacted individuals include those looking to implement new programs and systems or upgrade existing systems against these requirements and how to sustain and continual improve results.
How to Detect Lack of Data Integrity
Ron Snee
90 Min
Product Id: 706369
This webinar provides some practical and useful answers to the question: “How to Detect Lack of Data Integrity?” Humans, equipment or both can be the source of lack of data integrity. This session discusses both types of data integrity sources and introduces the assessment of “data pedigree” as a concept that puts focus on the types of data integrity issues and analytical and statistical methods for detecting data problems. Pharma and biotech case studies are used throughout the presentation to illustrate how the various approaches fit together.
5 Tips to Engage Your Associates In Your Safety Program
Michael Aust
60 Min
Product Id: 706163
This webinar will focus on evolving a zero-incident workplace culture within any organization; rather an existing or not. We will discuss the pro’s and con’s of a implementing a zero incident workplace culture and describe how to determine if you are doing it right.
Healthcare Systems Engineering to Solve Tough Patient Care Solutions
Dev Raheja
60 Min
Product Id: 706273
This webinar will cover the new paradigms for designing safe patient care in hospitals using healthcare systems engineering methodology such as the one used at Mayo Clinic. It will discuss how to predict harm to patients proactively and how to plan for Zero Harm at little or no cost resulting in high return on investment. It will cover real healthcare examples from the instructor’s experience based on his book Safer Hospital Care.
Managing Faculty & Staff Performance & Rewards in the 21st Century
Jim Castagnera
60 Min
Product Id: 706314
Attend this webinar to learn how to develop key performance indicators to implement a culture of engagement and accountability in the workplace. Typical performance reviews can be ineffective in the 21st century workplace environment, and too often, these cookie cutter types of evaluations are conducted without the benefits of a good understanding of the fundamental egalitarian nature of the environment.
Top 10 Training Programs - US Export and Import Requirements
Donna L Shira,Charles Jacque,Jan Seal
12 Hrs
Product Id: 706443
How To Deal with Toxic People
Michael Healey
90 Min
Product Id: 706397
Energy vampiring (people who suck all the energy out of situations and other people) and toxicity typically start out very subtle and nuanced. When left unchecked, the behaviors will metabolize into all aspects of interactions, eventually impacting everyone even close to the situation. Once a pattern has been established dealing with the discord can seem intractable. There is hope - the key to protecting yourself and the organizational, team or groups culture, is to recognize early on before the pattern becomes established, and take specific and intentional counter measures.