WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Gaining and Re-establishing Control of Your Cleanroom

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705317

This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.

15 / Jul / 2024 - Monday

* Per Attendee $199

 

FFIEC BSA/AML Examination Manual: What Compliance Officers Really Need to Know?

webinar-speaker   Doug Keipper

webinar-time   60 Min

Product Id: 703792

This webinar will go through every section of the revised FFIEC Bank Secrecy Act/Anti-Money Laundering Examination Manual to highlight changes and areas where banks should review their internal policies, processes and procedures for compliance. Understanding these changes will keep you prepared and updated for your next BSA/AML examination.

17 / Jul / 2024 - Wednesday

* Per Attendee $199

 

The Evolving Landscape for Management of Third Party Service Providers

webinar-speaker   Daniel Clark

webinar-time   60 Min

Product Id: 706980

Third Party Risk Management is all about managing service providers. For several years, businesses have been increasing reliance on third parties. While this reliance has many upsides, there are risks that should be recognized and managed. This session highlights those risks and provides alternatives to best manage them.

17 / Jul / 2024 - Wednesday

* Per Attendee $199

 

NEW Nacha Operating Rules Changes for 2024 PLUS Changes Coming in 2026 – Part 2

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 706981

Part 2 – Effective March 20, 2026, two Rule amendments (Fraud Monitoring – Phase 1) – monitoring for Faud (as part of a larger Risk Management package) intended to reduce the incidence of successful fraud attempts and improve the recovery of funds after frauds have occurred.

24 / Jul / 2024 - Wednesday

* Per Attendee $199

 

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 705783

This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning techniques and aseptic practices), ongoing monitoring practices with reference to sampling frequency, sampling locations and investigation of action level excursions and monitoring data.

24 / Jul / 2024 - Wednesday

* Per Attendee $199

 

Trial Master File and Clinical Data Management Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 705360

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

25 / Jul / 2024 - Thursday

* Per Attendee $199

 

FLSA White Collar Exemptions

webinar-speaker   Patrick A Haggerty

webinar-time   90 Min

Product Id: 706792

This session will review the current Department of Labor regulations as they apply to the white collar exemptions to the minimum wage and overtime requirement of the Fair Labor Standards Act (FLSA). The tests for exemption are the salary basis test, minimum salary requirement, and the duties tests. These tests have changed over the years and are complex and can be confusing. In addition, there are strict record keeping requirements and salary integrity requirements to prevent disqualification of the exemption. The webinar will also describe proposed changes to the rules and how employers can prepare for the changes.

29 / Jul / 2024 - Monday

* Per Attendee $199

 

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

webinar-speaker   David Nettleton

webinar-time   90 Min

Product Id: 701687

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

6 / Aug / 2024 - Tuesday

* Per Attendee $249

 

The 510(k) Mod Program, Breakthrough Technologies, and STeP

webinar-speaker   John E Lincoln

webinar-time   90 min

Product Id: 706976

What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.

7 / Aug / 2024 - Wednesday

* Per Attendee $199

 

Terminally Sterilized Pharmaceutical Products – Parametric Release ( New USP<1222>, November 2019) and its Relationship to the new British Terminal Steriliation Methodology (March 2019)

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706908

This General Information Chapter (USP<1222>) will first cover the general issues related to parametric release, regardless of the modes of sterilization, and then discuss some specific modes of sterilization. It will also include information on USP<55> Biological Indicators as well as EU “Guideline on the Sterilization of Medicinal Products…” (March 2019). The webinar will discuss why it provides more accurate information than the sterility test regarding the release of terminally sterilized product to the marketplace.

8 / Aug / 2024 - Thursday

* Per Attendee $199

 

Technical Writing for Medical Devices

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 706379

This technical writing training program will offer attendees an understanding of how the reporting process supports products in the medical device industry. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

9 / Aug / 2024 - Friday

* Per Attendee $249

 

Process Validation Requirements & Compliance Strategies

webinar-speaker   Jose Mora

webinar-time   60 Min

Product Id: 700162

This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.

14 / Aug / 2024 - Wednesday

* Per Attendee $199

 

Conducting an effective Regulatory Examination

webinar-speaker   Justin Muscolino

webinar-time   60 Min

Product Id: 706983

Are regulatory examinations keeping you up at night? In the world of financial institutions, staying ahead of the regulatory curve is more critical than ever.

15 / Aug / 2024 - Thursday

* Per Attendee $199

 

Essentials of Successful Fraud Risk Management

webinar-speaker   Daniel Clark

webinar-time   60 Min

Product Id: 706984

"Essentials of Successful Fraud Risk Management" is a session all about fraud. We begin by defining exactly what fraud looks like and provide a brief history of frauds impact to financial services.

20 / Aug / 2024 - Tuesday

* Per Attendee $199

 

Dietary Supplements' CGMPs, 21 CFR 111

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706360

What are the U.S. FDA's requirements for marketing and selling dietary supplements / nutraceuticals in the US, including their QMS per 21 CFR 111.

27 / Aug / 2024 - Tuesday

* Per Attendee $199

 

Decision-Making and Human Error Prevention

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706986

Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention." In today's complex and fast-paced world, the ability to make sound decisions and minimize the risk of human error is crucial across various professional domains.

28 / Aug / 2024 - Wednesday

* Per Attendee $199

 

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

webinar-speaker   David Nettleton

webinar-time   75 Min

Product Id: 701582

Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.

10 / Sep / 2024 - Tuesday

* Per Attendee $229

 

Document the Clinical Evaluation Report (CER) for the EU MDR and CE Mark

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706985

To document the clinical evaluation of a medical device and its output, a Clinical Evaluation Report or CER has to be compiled. The CER is an ongoing compilation of the generation, appraisal, and analysis of clinical data related to a device. It is one of the major components of the Technical Documentation File.

20 / Sep / 2024 - Friday

* Per Attendee $199

 

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 704315

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

Recording Available

 

Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences

webinar-speaker   Charles H Paul

webinar-time   90 Min

Product Id: 706939

The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.

Recording Available

 

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