WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Equipment Qualification and Process Validation

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705853

This equipment qualification and validation webinar will help you to understand the various processes of equipment qualifications (IQ, OQ & PQ) and process validation steps (when, what and how to tests) in a manufacturing process. It will also highlight all the requirements of FDA cGMP regulations that all equipment to be qualified and all manufacturing processes to be validated if problems are encountered changes have to made and periodically as necessary.

Recording Available

* Per Attendee $229

 

Regulatory Interactions with Health Authorities

webinar-speaker   Martin Lessem

webinar-time   90 Min

Product Id: 706330

This course will focus on Regulatory Interactions with Health Authorities. It will go over the basic types of meetings, correspondence, and committees which companies may use to interact with Health Authorities.

Recording Available

 

Bullet-Proof CAPA

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 700818

In this CAPA training program attendees will learn how compliant CAPA require specific failure investigations, and are dependent upon timely and accurate determination of root cause(s) such as Correction, Corrective Action, Impact Analysis, and Preventive Actions required to meet regulatory expectations.

Recording Available

* Per Attendee $299

 

How to Create a Drama Free Workplace

webinar-speaker   Michael Healey

webinar-time   90 Min

Product Id: 706376

This program details a comprehensive, field tested, step-by-step plan for eliminating drama in the workplace. The primary goal of this webinar is to equip attendees to recognize drama, even in its subtle forms, understand the impact and give them tips, tools and techniques to remove themselves from the person, professional and organizational consequences unchecked drama can have. To move from Despair to Empowerment.

Recording Available

* Per Attendee $249

 

E/M Coding: Finalized Changes for 2020 and 2021

webinar-speaker   Michael Stearns

webinar-time   60 Min

Product Id: 706328

CMS has changes to evaluation management coding for 2020 and 2021. The 2020 changes are significant and include new services and expansion of existing services. The changes finalized for 2021 include major changes to the physician requirements for documentation related to evaluation management coding.

Recording Available

* Per Attendee $249

 

State of the Art: Recommendations for writing a thorough SOA and build SOA Libraries for your CERs

webinar-speaker   Maria Sanchez

webinar-time   90 Min

Product Id: 706081

This webinar will showcase the importance of State of the Art in Clinical Evaluation Reports for Medical Devices and provide tools and recommendations for writing a well-structured SOA setting the stage for the entire CER. The webinar will also provide recommendations to build a State-of-the-Art Library for your medical device portfolio.

Recording Available

* Per Attendee $299

 

FDA Compliance and Mobile Applications

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706318

Attend this webinar to learn how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

Recording Available

 

Introduction to Medicare Coverage Analysis - Impact on Revenue Cycle

webinar-speaker   Mary Veazie

webinar-time   90 Min

Product Id: 706361

This course will describe the Medicare Coverage Analysis (MCA) process and the revenue cycle’s uses for this document. The course will describe the creation of the MCA and the multiple uses for this document.

Recording Available

 

Use Narrow Limit Gauging to Reduce Inspection Costs

webinar-speaker   William Levinson

webinar-time   60 Min

Product Id: 706311

In this Quality Management webinar attendees will learn the traditional attribute sampling plans required for very large samples & narrow limit gauging for smaller samples that relies on tightened acceptance limits to assess the quality of a sample which can reduce the required sample size and cost of inspection.

Recording Available

 

Objectionable Microorganisms in Biopharmaceutical Manufacturing

webinar-speaker   Carl Patterson

webinar-time   60 Min

Product Id: 705319

This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.

Recording Available

* Per Attendee $249

 

Red Hot Regulatory Issues: Status of President Trump's legislation, regulation and executive orders at the start of his re-election bid

webinar-speaker   Jim Castagnera

webinar-time   60 Min

Product Id: 706308

What has been the sum impact of this dizzying array of action for U.S. businesses and the American economy? What can corporate America expect in the final 18 months of his first Administration? What are his chances for re-election? And If he wins again, what can we anticipate in term two? In this webinar, get perspectives about these and more.

Recording Available

 

6-hr Virtual Seminar: Project Management for Human Resources

webinar-speaker   Rebecca Staton Reinstein

webinar-time   6 Hrs

Product Id: 706294

Attend this seminar to learn how to get the results your organization expects applying fundamental approaches to tackle special assignments and integrate your work into a large project, you manage productively and systematically.

Recording Available

 

Technical and Strategic Considerations in Performing Food Safety Management Systems Implementations (Session II)

webinar-speaker   Mike Weber

webinar-time   60 Min

Product Id: 706299

This Webinar, the second in a three-part series, focuses on the methodology behind performing Implementations of Food Safety Management Systems. This includes GFSI standards, USDA-FSIS, FDA Food Code 2017, HACCP, Preventative Controls, and FSMA under the broad umbrella of Food Safety Management Systems. Impacted individuals include those looking to implement new programs and systems or upgrade existing systems against these requirements.

Recording Available

 

Improving GLP QA in the coming Decade

webinar-speaker   Richard L Streeton

webinar-time   60 Min

Product Id: 706355

QA groups in the pre-clinical space need to be the driver of change and improvement in their organization. In the coming decade the reliance on management to be a driver of change is no longer a held value. Senior management is looking to QA to be to set the tone for the organization and be the champion of the changing regulatory environment.

Recording Available

 

Surviving an FDA Sponsor Inspection - Training for Success

webinar-speaker   Stephen Schwartz

webinar-time   105 Min

Product Id: 704516

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.

Recording Available

* Per Attendee $299

 

Employee Fraud Detection and Prevention

webinar-speaker   Peter Goldmann

webinar-time   90 Min

Product Id: 704040

This fraud training program will focus on understanding the fraud problem and what propels employees to commit fraud. The course will also offer essential fraud detection tools and techniques and highlight best practices for developing and implementing anti-fraud controls.

Recording Available

* Per Attendee $149

 

Critical Anti-Fraud Audits under Procurement and Accounts Payable

webinar-speaker   Marna Steuart

webinar-time   60 Min

Product Id: 703533

This webinar will explain how to perform anti-fraud audits in the purchasing/accounts payable cycle. It will discuss the use of Audit Control Language (ACL) and how this tool and other tools like it (IDEA) are helpful in the analysis of accounts payable and purchasing data.

Recording Available

* Per Attendee $249

 

How to Write Technical Papers

webinar-speaker   Gholamreza Zahedi

webinar-time   60 Min

Product Id: 706335

This webinar will cover how to write a paper. Guidelines on framing a paper, journal selection and tips for publishable paper will be provided.

Recording Available

 

Validation of GC / GC-MS Methodologies

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 705259

This training program will cover in detail the method validation of gas chromatography (GC) and gas chromatography mass spectrometry (GC-MS). It will focus on key elements of validation including injector, column, detection system, data system and much more.

Recording Available

* Per Attendee $199

 

Effective (FDA Accepted) Responses to FDA-483's and Warning Letters

webinar-speaker   Larry Stevens

webinar-time   60 Min

Product Id: 705629

This webinar will provide an overview of how to prepare effective responses to warning letters that FDA will consider acceptable. It will help you know how to negotiate with FDA to effectively close Warning Letters.

Recording Available

* Per Attendee $199

 

 

 

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