WEBINARS

 

Compliance Training Webinars for Regulated Industries

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How To Create an Effective Export Control Compliance Program under the Export Administration Regulations in 2023

webinar-speaker   Douglas Cohen

webinar-time   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).

Recording Available

* Per Attendee $149

 

Useful Statistical Methods for Defining Product and Process Specifications - Part II

webinar-speaker   Steven Wachs

webinar-time   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.

Recording Available

* Per Attendee $249

 

How to Prepare an Effective Audit Manual for an Internal Audit Department

webinar-speaker   Marna Steuart

webinar-time   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.

Recording Available

* Per Attendee $249

 

How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV

webinar-speaker   Frank Stein

webinar-time   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.

Recording Available

* Per Attendee $249

 

Monitoring High Risk Transactions

webinar-speaker   Doug Keipper

webinar-time   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.

Recording Available

* Per Attendee $249

 

Cybersecurity and US FDA Requirements

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $229

 

Workplace Violence Prevention

webinar-speaker   Joe Keenan

webinar-time   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.

Recording Available

* Per Attendee $179

 

Knowing your Post-Market Clinical Follow-up (PMCF)

webinar-speaker   Frank Stein

webinar-time   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.

Recording Available

* Per Attendee $249

 

Useful Statistical Methods for Defining Product and Process Specifications - Part I

webinar-speaker   Steven Wachs

webinar-time   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.

Recording Available

* Per Attendee $249

 

Managing Risks in Combination Products and Drug Delivery Systems

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $249

 

Writing an Effective SAR Narrative

webinar-speaker   Doug Keipper

webinar-time   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.

Recording Available

* Per Attendee $199

 

Inspection and Audit Readiness Training for Medical Device Manufacturers

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $249

 

Bloodborne Pathogens

webinar-speaker   Joe Keenan

webinar-time   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.

Recording Available

* Per Attendee $199

 

ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course

webinar-speaker   Barry A Friedman

webinar-time   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.

Recording Available

* Per Attendee $249

 

Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs

webinar-speaker   Barry A Friedman

webinar-time   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.

Recording Available

* Per Attendee $249

 

Business Writing for Financial Professionals

webinar-speaker   Phil Vassallo

webinar-time   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.

Recording Available

* Per Attendee $249

 

Combination Product Device Supplier Management Training

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $249

 

Stop Payments vs Unauthorized Entries – Compliance with the Nacha Operating Rules

webinar-speaker   Donna K Olheiser

webinar-time   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!

Recording Available

* Per Attendee $249

 

Writing High-Impact Executive Summaries

webinar-speaker   Phil Vassallo

webinar-time   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.

Recording Available

* Per Attendee $249

 

Conducting Remote Medical Device QMS Audits Training

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $249

 

 

 

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