WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Critical Role of Quality Audit in GxP Compliance & Improvement

webinar-speaker   David Dills

webinar-time   62 Min

Product Id: 700982

This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Learn the basic skills required and how to apply them and the knowledge in becoming more effective.

Recording Available

* Per Attendee $299

 

Managing Corporate Risks with ISO 31000

webinar-speaker   Kelly Eisenhardt

webinar-time   60 Min

Product Id: 705083

ISO 31000 is a standard developed by the International Organization for Standardization (ISO) which provides a basic guideline and principles for the application of risk management. Companies that use risk management processes vary across industries in scope and magnitude and address a wide variety of challenges. This training program will offer an in depth look into the key components of the ISO 31000 guideline and best practices to implement and support a corporate risk management strategy or program.

Recording Available

 

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.

Recording Available

* Per Attendee $249

 

Social Media Compliance for Fair Lending: What to post and what not to

webinar-speaker   Justin Muscolino

webinar-time   60 Min

Product Id: 706987

Ensure compliance in your social media marketing efforts with our "Social Media Compliance for Fair Lending" training. Learn what content is permissible and what's not to avoid potential regulatory issues. This course covers guidelines for posting on various social media platforms while adhering to fair lending laws. Gain insights into creating compliant content that promotes transparency and fairness in your lending practices. Equip your team with the knowledge needed to navigate the complexities of social media compliance, mitigate risks, and maintain regulatory adherence in your digital marketing strategies.

Recording Available

* Per Attendee $249

 

How to Manage a Medical Device Recall Efficiently and Effectively

webinar-speaker   David Dills

webinar-time   64 min

Product Id: 700911

This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. Attend this webinar to know what happens in a recall and what are the strategies and operational procedures in a recall.

Recording Available

* Per Attendee $50

 

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.

Recording Available

* Per Attendee $249

 

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.

Recording Available

* Per Attendee $249

 

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.

Recording Available

 

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

webinar-speaker   Steven Wachs

webinar-time   75 Mins

Product Id: 705020

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.

Recording Available

 

Mapping a Pharmaceutical Ingredient Bulk Manufacturing Workflow

webinar-speaker   Michael Esposito

webinar-time   90 Mins

Product Id: 707020

Mapping and evaluating all the steps in a current pharmaceutical ingredient bulk manufacturing workflow can lead to valuable process improvements. In this webinar, we discuss how this review can be accomplished and the possible benefits that can result.

Recording Available

 

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

 

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.

Recording Available

* Per Attendee $249

 

Clinical Trial Systems: The Trial Master File (TMF) and Electronic Trial Master File (eTMF)

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706938

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle. Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.

Recording Available

* Per Attendee $229

 

Proposed NACHA Operating Rules - Hear the Latest NEWS in the Rules Space

webinar-speaker   Donna K Olheiser

webinar-time   60 Min

Product Id: 705835

This NACHA Operating Rules training session will provide the details on the proposed changes that potentially may be happening in the future. How it is going to impact you and what can you do about it.

Recording Available

 

Preparing for Pre-Approval Inspections

webinar-speaker   Joy McElroy

webinar-time   90 Mins

Product Id: 707019

A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug application is capable of consistently manufacturing a safe drug product, and that the submitted data is accurate and complete against what was filed in their application. This training will provide guidance on when the FDA performs pre-approval inspections. It will describe how to prepare for a PAI, and the outcomes of pre-approval inspections.

Recording Available

* Per Attendee $249

 

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.

Recording Available

* Per Attendee $249

 

US FDA Requirements for Medical Products Labeling / UDI

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706969

The U.S. FDA has several requirement for the labeling of medical products. The key requirements are in 21 CFR 801.

Recording Available

* Per Attendee $249

 

How to Address ISO's New Climate Change Requirements

webinar-speaker   William Levinson

webinar-time   60 Min

Product Id: 706977

New ISO standards, including ISO 9001, will include additional requirements related to climate change. These fortunately do not involve carbon neutrality goals, but do require organizations to consider climate change and also potential requirements of relevant interested parties.

Recording Available

* Per Attendee $249

 

The GLPs and Analytical Test Methods Validation

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706978

Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al

Recording Available

* Per Attendee $249

 

 

 

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