
Analytical Method Development, and Method Transfer
John E Lincoln
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.

How to conduct an effective BSA Audit
Justin Muscolino
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.
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
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).

US Market Access & Reimbursement : Medical Devices
Robert J Russell
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

Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Michael Esposito
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.

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.
The 6 Most Common Problems in FDA Software Validation and Verification
David Nettleton
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.

Toxic Substance Control Act (TSCA) Awareness Training 101
Joe Keenan
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.

You have a BI Positive or Product Sterility Positive - Now What?
Gerry O Dell
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.

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
Roger Cowan
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.

Conducting Effective Quality Audits: Beyond Audit Checklists
Michael Ferrante
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.

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Joy McElroy
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.

Trial Master File and Clinical Data Management Regulated by FDA
Carolyn Troiano
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.

Installation and Qualification of the Packaging Lines
John E Lincoln
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

EPA Tier II Reporting
Joe Keenan
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.

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

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

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals
Kelly Eisenhardt
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.

Preapproval Inspection and Submission to the FDA
John E Lincoln
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.

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