WEBINARS

 

Compliance Training Webinars for Regulated Industries

Troubleshooting Dissolution Methods for Solid Oral Dosage Forms

webinar-speaker   Mark Powell

webinar-time   60 Min

Product Id: 706599

The root cause of variable or inconsistent data from compendial dissolution tests can be difficult to identify. Formulation, equipment, operator error and incorrect calculation may be factors. This webinar presents a systematic, logical approach to investigating anomalous dissolution results.

18 / Oct / 2021 - Monday

* Per Attendee $229

 

Medical Device Software Development Under IEC 62304

webinar-speaker   Don Hurd

webinar-time   60 Min

Product Id: 706744

ANSI/AAMI/IEC 62304 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance to it provides a presumption of conformity to the requirements within those jurisdictions. Not complying with the standard has shown to lead to longer regulatory review times and frequent rejections.

19 / Oct / 2021 - Tuesday

* Per Attendee $199

 

Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do

webinar-speaker   William Mack Copeland

webinar-time   60 Min

Product Id: 705230

This webinar will review not only the Anti-Kickback Statute and its safe harbors, but will provide an in-depth overview of OIG guidance and advisory opinions dealing with marketing activities, as well as a review of case law regarding marketing behavior.

20 / Oct / 2021 - Wednesday

* Per Attendee $199

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

20 / Oct / 2021 - Wednesday

* Per Attendee $199

 

Best Practices in Preparation for an FDA Computer System Audit

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706354

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit. It will also consider areas where FDA will likely focus their effort, including on the higher-risk systems. It will cover areas that will help you to plan for an on-site inspection.

20 / Oct / 2021 - Wednesday

* Per Attendee $249

 

The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?

webinar-speaker   Dr. Susan Strauss

webinar-time   90 Min

Product Id: 704959

The webinar training will address ADAAA, FMLA, and Worker’s Comp laws that HR is responsible for upholding. When the laws are not followed, it increases the liability for the organization and interferes with a fair and equitable work environment for employees.

20 / Oct / 2021 - Wednesday

* Per Attendee $199

 

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

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).

20 / Oct / 2021 - Wednesday

* Per Attendee $249

 

Reviewing Drug Product Batch Records

webinar-speaker   Mark Powell

webinar-time   60 Min

Product Id: 706287

Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.

21 / Oct / 2021 - Thursday

* Per Attendee $199

 

Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706751

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the essentials of design controls for medical devices.

22 / Oct / 2021 - Friday

* Per Attendee $249

 

Implementing Operational Risk Management in Foreign Exchange Activities

webinar-speaker   Stanley Epstein

webinar-time   90 Min

Product Id: 704115

This webinar seeks to provide a solid foundation to all parties involved in foreign exchange activities whether at executive, marketing, audit or operational levels into how the actual trading processes work, what the risks are and how these can be mitigated by using clearly defined standards of best practice.

26 / Oct / 2021 - Tuesday

* Per Attendee $199

 

How to Survive a DEA Inspection - Veterinary Medicine and Controlled Substances

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 704885

This webinar will discuss federal laws on administering and dispensing veterinary medicine, penalties for non-compliance, DEA required records and effective methods to prevent unauthorized use of controlled substances.

27 / Oct / 2021 - Wednesday

* Per Attendee $229

 

21 CFR Part 111 - FDA Inspections for Dietary Supplements - How to Prepare

webinar-speaker   Andy Swenson

webinar-time   60 Min

Product Id: 706752

cGMP compliance for dietary supplements is mandated by FDA regulation 21 CFR part 111, which stipulates that anybody who produces, packages, labels, or holds a dietary supplement must create and implement current Good Manufacturing Practices (cGMPs) to ensure the supplement's quality. An FDA inspection is always imminent in a regulated industry. Their causes vary from receiving unknown SAERs to a scheduled visit. Regardless of the cause, the result is the same: THE FDA IS COMING.

27 / Oct / 2021 - Wednesday

* Per Attendee $199

 

Implementing a Quality Management System

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 705971

This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.

27 / Oct / 2021 - Wednesday

* Per Attendee $249

 

Project Management for FDA-Regulated Companies

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 701758

This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.

27 / Oct / 2021 - Wednesday

* Per Attendee $199

 

Access Point Case Management: Managing the Two-Midnight Rule via Your Routes of Entry

webinar-speaker   Toni Cesta

webinar-time   60 Min

Product Id: 706045

This case management webinar will explore how an initial assessment and clinical review can better ensure that patient is placed in the correct setting right from the get-go which is a very unique role played by ED and admitting office, transfer center case managers and social workers. The 2 midnight rule and the part that case management plays in managing it will also be reviewed. It will give idea about reducing the use of Condition Code 44 or self-denials when patients get admitted to the incorrect level.

28 / Oct / 2021 - Thursday

* Per Attendee $199

 

"Front-End, Middle, and Back-End" Approach to Credit Management

webinar-speaker   David L Osburn

webinar-time   60 Min

Product Id: 705808

This credit management webinar will discuss the credit analysis process, how to do financial statement analysis and how to do effective cash management using various tools and techniques and how to use various collection techniques (manage legal issues and using negotiation skills) and overall how to manage the collection process.

Recording Available

* Per Attendee $299

 

How to Conduct Successful Supplier Audits

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704499

This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.

Recording Available

* Per Attendee $249

 

Basic and Meaningful Human Resource Metrics

webinar-speaker   Greg Chartier

webinar-time   70 Min

Product Id: 701696

Learn different HR metrics which can be used across organization to improve performance of human resources

Recording Available

* Per Attendee $229

 

Tax Evasion and Tax Fraud - What it means to you when monitoring BSA and filing SARs

webinar-speaker   Doug Keipper

webinar-time   60 Min

Product Id: 703110

This training on BSA compliance will help you understand the concept of tax evasion and tax fraud and the difference between the two. Learn the best practices to identify tax fraud and how to report suspicious activity.

Recording Available

* Per Attendee $249

 

The New OSHA Recordkeeping and Reporting Requirements-300, 300A, 301

webinar-speaker   Michael Aust

webinar-time   60 Min

Product Id: 704465

This webinar training will discuss the recent updates in OSHA Recordkeeping and Reporting Requirements. Speaker will explain the major regulatory changes that went into effect January 1, 2015 Participants will gain valuable understanding of 300, 300A and 301 log, new reporting timeline requirements and exemptions.

Recording Available

* Per Attendee $249

 

 

 

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