How To Create an Effective Export Control Compliance Program under the Export Administration Regulations in 2023
Douglas Cohen
60 Min
Product Id: 703983
This training program will assist attendees in establishing and enhancing an export compliance program and offer best practices for export compliance given under the Export Administration Regulations (EARs).
Useful Statistical Methods for Defining Product and Process Specifications - Part II
Steven Wachs
75 Min
Product Id: 706898
This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.
How to Prepare an Effective Audit Manual for an Internal Audit Department
Marna Steuart
60 Min
Product Id: 703684
This webinar will instruct attendees on how to develop an internal audit manual and offer start to finish instructions and templates on how to perform different types of audits given the project description. Audit fieldwork, audit reporting and follow-up, work-paper filing, and project closure are some of the other areas the webinar will cover.
How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV
Frank Stein
75 Min
Product Id: 706887
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system and your technical documentation. Your implementation needs smart ideas to reach the right level to pass the quality management audits and technical documentation audits and review by your notified body.
Monitoring High Risk Transactions
Doug Keipper
60 Min
Product Id: 703001
This BSA/AML (Bank Secrecy Act/ Anti Money Laundering) compliance training will help attendees understand, identify and mitigate the risks associated with high risk transactions.
Cybersecurity and US FDA Requirements
John E Lincoln
90 Min
Product Id: 706716
Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information.
Workplace Violence Prevention
Joe Keenan
60 Min
Product Id: 705522
This webinar will teach you how to get proactive and put programs in place to prevent a workplace violence episode and how to respond to an active shooter scenario. This training will discuss in detail the Do's and Don'ts in reference to workplace violence prevention.
Knowing your Post-Market Clinical Follow-up (PMCF)
Frank Stein
60 Min
Product Id: 706888
Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in clinical post market surveillance into your current quality management system according to ISO 13485:2021. Your implementation needs smart ideas to reach the right level to pass the quality management audit by your notified body or authority inspection.
Useful Statistical Methods for Defining Product and Process Specifications - Part I
Steven Wachs
75 Min
Product Id: 706897
This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.
Managing Risks in Combination Products and Drug Delivery Systems
John E Lincoln
90 Min
Product Id: 706878
This webinar will provide valuable guidance to regulated companies in development and implementation of Product Risk Management Planning, Implementation, and Use. There will be added focus on the special needs of combination products. Also increased focus on the often high risk considerations of drug delivery systems, with the recent increased concern posed by potential cybersecurity vulnerabilities. This webinar will expand this tool into R&D design control, training, marketing, validtion, root cause analysis, CAPA / fralure investigations, GMP auditing, and liability reduction. Regular use of a few simple but powerful tools in a Product Risk Management File and Review template can contribute greatly to reduction of product liability, company-wide cost reduction efforts, less chance of recalls, and an improved bottom line.
Writing an Effective SAR Narrative
Doug Keipper
60 Min
Product Id: 702993
This BSA compliance training on Suspicious Activity Reporting (SAR) will provide details on how to prepare a SAR (Suspicious Activity Reporting) narrative that meets examiner scrutiny and provides necessary detail for law enforcement.
Inspection and Audit Readiness Training for Medical Device Manufacturers
John E Lincoln
90 Min
Product Id: 706877
This webinar will focus on how to prepare domestic and foreign medical device manufacturers selling to the U.S. to recognize and prepare for FDA pre- and post-market inspections.
Bloodborne Pathogens
Joe Keenan
60 Min
Product Id: 706902
This course will teach you what the OSHA Bloodborne Pathogens Program requires to protect you and your Employees against obtaining a life-threatening disease.
ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course
Barry A Friedman
90 Min
Product Id: 706881
This live, interactive training webinar will examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2 and 3. It will cover testing requirements as part of “Laboratory Controls” during each Phase and what laboratory testing may be optional until the ingredient moves to its next Phase. It will determine what options exist — even within a Phase 2 or Phase 3 testing framework. It will discuss compendial vs. non-compendial testing and how to respond when no method is available. Within the past several years the FDA has also issued a significant number of Warning Letters pertaining to 21 CFR 211.84 which involve management of raw/in-coming materials and which correspond to various sections within ICH Q7A. Please plan to attend the upcoming 90-minute Compliance OnLine webinar to learn how to avoid receiving this common citation and maintaining compliance with ICH Q7A. Please plan to bring an interdisciplinary group to obtain the most from this webinar.
Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs
Barry A Friedman
90 Min
Product Id: 706882
The objective of this live, interactive training webinar is to explore the role of media fills in assuring that manufactured product will retain the sterility assurance level prescribed by GMPs. It will review the issues regarding preparing media and setting up the “filtration train”, environmental monitoring, interruptions that may occur during the operation of the Clean Room (planned and unplanned) and the cleaning of the room and its equipment. Equipment used to monitor the equipment and personnel will also be reviewed along with gowning issues that periodically arise. The webinar will also discuss media failures and how to “work through” them. Because of the sensitivity and importance of media fills, this live, interactive training webinar is a MUST for anyone in your organization that is involved in aseptic filling in general and media fills, in particular.
Business Writing for Financial Professionals
Phil Vassallo
90 Min
Product Id: 703262
This training on business writing will provide attendees tools and tips for effectively writing financial documents for diverse audiences. Learn best practices for getting an immediate response to any written document.
Combination Product Device Supplier Management Training
John E Lincoln
90 Min
Product Id: 706876
The U.S. FDA continues to increase its requirements for tighter control and management of vendors / suppliers / outsourcing. Combination products doubles the problems. And Covid 19 has compounded supply chain issues.
Stop Payments vs Unauthorized Entries – Compliance with the Nacha Operating Rules
Donna K Olheiser
90 Min
Product Id: 704319
This training program will help find answers to many struggles with Stop Payments and Unauthorized Entries. These are still the number one issues in the exception processing of ACH transactions on a daily basis. This 90-minute session will definitely help clear things up on processing unauthorized, authorization revoked and stop payments!
Writing High-Impact Executive Summaries
Phil Vassallo
90 Min
Product Id: 704127
This training program will help attendees approach the writing situation with a clear and useful strategy. It will include strategies to fuse the purpose of the summary with the issues that matter to your audience. Attendees will also learn to sort ideas to clarify key points and craft paragraphs that reinforce the intent of the executive summary.
Conducting Remote Medical Device QMS Audits Training
John E Lincoln
90 Min
Product Id: 706875
Remote QMS-CGMP compliance inspections are here to stay. Add it to your toolbox for vendor and remote site audits, especially for low to moderate risk companies.