WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Analytical Method Development, and Method Transfer

webinar-speaker   John E Lincoln

webinar-time   90 mins

Product Id: 707009

The U.S. FDA and EU's MDR require specific steps to be fulfilled to develop and/or transfer analytical methods to maintain accuracy.

6 / May / 2025 - Tuesday

* Per Attendee $199

 

How to conduct an effective BSA Audit

webinar-speaker   Justin Muscolino

webinar-time   60 min

Product Id: 706979

BSA rules and regulations must be followed by financial institutions. Although financial institutions have been managing BSA operations in accordance with regulatory requirements, the shift to BSA audits has become increasingly important. Regulators look to the financial institution for confirmation and proof that BSA operations are being audited properly to ensure that BSA efforts are implemented and managed properly.

7 / May / 2025 - Wednesday

* 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).

7 / May / 2025 - Wednesday

* Per Attendee $229

 

US Market Access & Reimbursement : Medical Devices

webinar-speaker   Robert J Russell

webinar-time   60 Min

Product Id: 706989

This targeted 60-minute U.S. Reimbursement training/webinar will help you understand and navigate the complex U.S. system for understanding product reimbursement status and potential for your Medical Device

9 / May / 2025 - Friday

* Per Attendee $199

 

Strategies To Prevent Manufacture And Distribution Of Substandard Medications

webinar-speaker   Michael Esposito

webinar-time   90 Min

Product Id: 706104

Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of these problems.

13 / May / 2025 - Tuesday

* Per Attendee $199

 

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.

14 / May / 2025 - Wednesday

* Per Attendee $199

 

The 6 Most Common Problems in FDA Software Validation and Verification

webinar-speaker   David Nettleton

webinar-time   120 Min

Product Id: 705582

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

4 / Jun / 2025 - Wednesday

* Per Attendee $249

 

Toxic Substance Control Act (TSCA) Awareness Training 101

webinar-speaker   Joe Keenan

webinar-time   90 mins

Product Id: 706205

Attend this training to understand all the requirements of the Toxic Substance Control Act (TSCA), its revisions, and how to develop a written plan, TSCA Training Plan. Get answers to your TSCA questions.

5 / Jun / 2025 - Thursday

* Per Attendee $199

 

You have a BI Positive or Product Sterility Positive - Now What?

webinar-speaker   Gerry O Dell

webinar-time   75 Min

Product Id: 703288

This webinar explains what actions should be taken following an unexpected positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It also addresses the actions to take when a test of sterility demonstrates unexpected growth during validation or routine dose audits. The various items that should be investigated to determine the root cause and the follow up to the investigation will be covered.

Recording Available

* Per Attendee $249

 

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703727

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

Recording Available

* Per Attendee $249

 

Conducting Effective Quality Audits: Beyond Audit Checklists

webinar-speaker   Michael Ferrante

webinar-time   60 Min

Product Id: 703539

This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.

Recording Available

* Per Attendee $249

 

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704531

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the 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.

Recording Available

* Per Attendee $249

 

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.

Recording Available

* Per Attendee $249

 

Installation and Qualification of the Packaging Lines

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706996

Both the U.S. FDA and EU's MDR expect documented risk-based IQ, OQ, an PQs of medical packaging lines under U.S. FDA cGMP, EU MRD, ICH Q7 and Q9 and ISO 14971

Recording Available

* Per Attendee $249

 

EPA Tier II Reporting

webinar-speaker   Joe Keenan

webinar-time   60 Min

Product Id: 705125

This training program will enumerate the requirements of the Emergency Planning and Community Right-to-Know Act (EPCRA) as it applies to your organization. It will also help attendees understand the threshold trigger for reporting a hazardous chemical on the Tier II forms and learn how to accurately calculate chemical mixtures as it applies to the Tier II forms. Further, attendees will learn to navigate the complexities of online Tier II reporting.

Recording Available

* Per Attendee $249

 

Process for Performing a Vendor/Contract Audit: What Should be Considered and How to Plan, Perform and Report Results of a Vendor Audit

webinar-speaker   Marna Steuart

webinar-time   75 min

Product Id: 706219

Attend this webinar to learn about the different contract terms, different ways to determine the scope of the audit given contract terms and conditions, how to plan, perform and report results of a vendor audit.

Recording Available

* Per Attendee $249

 

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

webinar-speaker   Roger Cowan

webinar-time   60 min

Product Id: 703476

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

Recording Available

* Per Attendee $249

 

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

webinar-speaker   Kelly Eisenhardt

webinar-time   60 Min

Product Id: 703871

This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.

Recording Available

* Per Attendee $249

 

Preapproval Inspection and Submission to the FDA

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706998

This webinar is intended to provide guidance regarding the FDA program to approve an NDA or an ANDA or PMA only if the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug or Class III device are found adequate to ensure and preserve the drug's identity, strength, quality, and purity, or the device's safety and performance.

Recording Available

* Per Attendee $249

 

Supplier Management with the new Medical Device Regulation EU MDR 745/2017

webinar-speaker   Frank Stein

webinar-time   60 Min

Product Id: 706068

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.

Recording Available

* Per Attendee $229

 

 

 

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