WEBINARS

 

Compliance Training Webinars for Regulated Industries

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US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702029

This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it’s goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.

25 / Oct / 2024 - Friday

* Per Attendee $199

 

Conducting an effective Regulatory Examination

webinar-speaker   Justin Muscolino

webinar-time   60 Min

Product Id: 706983

Are regulatory examinations keeping you up at night? In the world of financial institutions, staying ahead of the regulatory curve is more critical than ever.

28 / Oct / 2024 - Monday

* Per Attendee $199

 

IRB Submissions Reviews and Approvals

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706992

To establish that a drug or device is safe and effective, tests are required. There are many preliminary tests, including lab tests, standards, guidances, etc. Finally the product must be tried out on humans / patients in a tightly controlled environment. The clinical site(s) IRB Review is and FDA requirement and crucial to obtaining a site(s).

5 / Nov / 2024 - Tuesday

* Per Attendee $199

 

Analytical Method Validation and Transfer

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 706186

This course will provide a thorough review of regulatory guidelines on method validation and transfer. It provides guidance on how to perform QC analytical test method validations and transfers.

5 / Nov / 2024 - Tuesday

* Per Attendee $229

 

FDA Bioresearch Monitoring Inspection Program 2024

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 706994

This webinar presents a survey of the FDA’s Bioresearch Monitoring Program, a series of FDA inspection programs covering regulatory inspections by the FDA of clinical trial sites, sponsors and Clinical Research Organizations, nonclinical testing laboratories, Institutional Review Boards (IRBs) and post marketing adverse event reporting requirements.

6 / Nov / 2024 - 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).

6 / Nov / 2024 - Wednesday

* Per Attendee $249

 

China Regulatory Compliance for Life Sciences

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702037

China’s Life Sciences Compliance webinar will discuss the regulatory structure and requirements for compliance against China’s NMPA regulations for Pharmaceuticals, Medical Devices, Biologics and Combination Products.

8 / Nov / 2024 - Friday

* Per Attendee $199

 

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703590

This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.

11 / Nov / 2024 - Monday

* Per Attendee $199

 

Conducting an ACH Risk Assessment and Developing an Effective Risk Management Program

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 706995

According to the Nacha Operating Rules, financial institutions are required to assess and manage all ACH risks, which includes developing a Risk Management program. Most ACH risk can be mitigated through proper due diligence for all originating customers (KYC) and strict adherence to ACH origination and credit policies, which includes monitoring ACH activity.

12 / Nov / 2024 - Tuesday

* Per Attendee $199

 

Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705130

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

13 / Nov / 2024 - Wednesday

* Per Attendee $199

 

Operational Risk Management Principles

webinar-speaker   Stanley Epstein

webinar-time   90 Min

Product Id: 706024

This webinar provides participants with practical guidance in implementing an effective operational risk management system. It will also bring you up to speed on current best practice in the field of managing operational risk in financial institutions. Not only will we examine the details of each of these principles, as well as taking an all-inclusive look and what needs to happen to implement them; we will complete our journey by examining the principles under the harsh light of an actual Case Study in the banking industry.

19 / Nov / 2024 - Tuesday

* Per Attendee $199

 

Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability

webinar-speaker   Dr. Susan Strauss

webinar-time   75 Min

Product Id: 704699

This training program will list and enumerate relevant laws, regulations and standards required for health equity and patient-centered care of LGBT patients. It will discuss opportunities to collect LGBT–relevant data and information during the healthcare encounter and help chart strategic community outreach efforts to the LGBT population.

19 / Nov / 2024 - Tuesday

* Per Attendee $199

 

Predicting Product Life Using Reliability Analysis Methods

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 702096

Achieving high product reliability has become increasingly vital for manufacturers in order to meet customer expectations amid the threat of strong global competition. Poor reliability can doom a product and jeopardize the reputation of a brand or company. Inadequate reliability also presents financial risks from warranty, product recalls, and potential litigation. When developing new products, it is imperative that manufacturers develop reliability specifications and utilize methods to predict and verify that those reliability specifications will be met. This presents a difficult challenge in many industries with short product cycles and compressed product development time frames. This webinar provides an overview of quantitative methods for predicting product reliability from data gathered from physical testing or from field data.

20 / Nov / 2024 - Wednesday

* Per Attendee $199

 

Terminally Sterilized Pharmaceutical Products – Parametric Release ( New USP<1222>, November 2019) and its Relationship to the new British Terminal Steriliation Methodology (March 2019)

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706908

This General Information Chapter (USP<1222>) will first cover the general issues related to parametric release, regardless of the modes of sterilization, and then discuss some specific modes of sterilization. It will also include information on USP<55> Biological Indicators as well as EU “Guideline on the Sterilization of Medicinal Products…” (March 2019). The webinar will discuss why it provides more accurate information than the sterility test regarding the release of terminally sterilized product to the marketplace.

20 / Nov / 2024 - Wednesday

* Per Attendee $199

 

Decision-Making and Human Error Prevention

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706986

Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention." In today's complex and fast-paced world, the ability to make sound decisions and minimize the risk of human error is crucial across various professional domains.

3 / Dec / 2024 - Tuesday

* Per Attendee $199

 

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

3 / Dec / 2024 - Tuesday

* 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.

3 / Dec / 2024 - Tuesday

* Per Attendee $249

 

Establishing a Robust Supplier Management Program

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 706055

This course will review regulatory guidance governing Suppliers and the elements of a robust supplier management program including, initial qualification, supplier performance monitoring, and scorecards, supplier audit options, and quality agreement requirements. It will discuss how to utilize risk-based quality tools to determine supplier classification with a risk assessment example. Recent FDA audit findings will also be reviewed.

4 / Dec / 2024 - Wednesday

* Per Attendee $229

 

Fundamentals of Good Clinical Practice

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 706997

This webinar introduces the concept of Good Clinical Practice (GCP), primarily from a US perspective. The webinar presents an overview of the FDA’s GCP regulations for drugs and medical devices. It also summarizes the key objectives of GCP and the responsibilities of Sponsors of clinical trials and site level clinical investigators.

5 / Dec / 2024 - Thursday

* Per Attendee $199

 

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703831

Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.

10 / Dec / 2024 - Tuesday

* Per Attendee $199

 

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