WEBINARS

 

Analytical Laboratory Regulatory Compliance Training - Live Webinars, Recordings & CDs

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

Recording Available

* Per Attendee $299

 

The Use of Monitoring and Statistics to Prevent Non-Compliance in the Laboratory

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 705292

This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation in the laboratory.

Recording Available

* Per Attendee $249

 

Laboratory Accreditation (ISO/IEC 17025): Everything Old is New Again

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 705272

This training program will discuss in details the new requirements of ISO/IEC 17015:2017 laboratory accreditation standard and their impact on quality management system. It will provide you with an overview of the salient differences and similarities between the old and the new standard and provide advice on what you must do to meet the requirements each of the elements.

Recording Available

* Per Attendee $229

 

How to Survive a DEA Inspection Series: For DEA Registered Analytical Labs and Research Facilities

webinar-speaker   Carlos M Aquino

webinar-time   60 Min

Product Id: 704617

The training program will cover DEA record-keeping requirements and effective security that a DEA registrant must comply with when handling controlled substances. It covers elements of what occurs during an unannounced inspection and the auditing methods.

Recording Available

* Per Attendee $299

 

SOP's for Bioanalytical Methods Validation

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 704916

This webinar will help you learn how to validate bioanalytical methods. This session will teach you the pitfalls behind bioanalytical methods validation, allowing one to transition between assays with ease.

Recording Available

 

Data Integrity in the Pharmaceutical Laboratory: Practical Steps to Identify and Avoid Data Integrity Issues

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 705347

This webinar will discuss in detail the fundamentals of data integrity including the FDA guidance document. It will teach attendees practical steps to identify and avoid data integrity issues in pharmaceutical laboratory.

Recording Available

* Per Attendee $249

 

Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 705325

This webinar provides understanding of the requirements for residual solvents addressed in ICH, USP, EP and JP and focus on the recent changes to USP <467>. It will also help attendees utilize strategies to minimize the testing and resources required to meet the requirements.

Recording Available

* Per Attendee $249

 

Gaining and Re-establishing Control of Your Cleanroom

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705317

This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.

Recording Available

* Per Attendee $249

 

Transfer of Analytical Methods According to the USP Chapter <1224>

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 701971

This webinar will explain the final version of USP Chapter <1224> and FDA guidance for conducting and documenting method transfer between laboratories and sites, and provide tools for effective implementation.

Recording Available

* Per Attendee $249

 

How to undergo an FDA Inspection Successfully

webinar-speaker   Marie Morin

webinar-time   90 Min

Product Id: 705170

This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.

Recording Available

* Per Attendee $249

 

Ensure successful FDA/Global Site Inspections and Maximize Potential Regulatory Opportunities by establishing effective Pharmaceutical Quality System (per ICH Q10 guidance document)

webinar-speaker   Stephanie Cooke

webinar-time   90 Min

Product Id: 705477

This webinar will discuss the requirements for handling deviation based on GMPs, ICH guidance documents and other relevant guidance. It will also explain ICH Q8, Q9, and Q10 guidance documents and will provide best practices to ensure compliance with these documents in regards to handling deviations and nonconforming products.

Recording Available

 

Selection and Auditing of Analytical Contract Laboratories: Best Practices for Pharmaceutical Scientists

webinar-speaker   Daniel Norwood

webinar-time   90 Min

Product Id: 705169

This webinar on selection and auditing of analytical contract laboratories will guide the participants to understand the process of CRO selection for analytical testing. Attendees will gain knowledge on the basic principles of quality auditing of a CRO; including audit planning, scheduling, conducting an audit, and the audit report process.

Recording Available

* Per Attendee $249

 

Laboratory Accreditation and Quality Management Systems Part 2: Technical Concerns

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 705299

This laboratory accreditation training program will focus on technical components of Quality Management System (QMS) including accommodation and environmental conditions, test and calibration methods, equipment, measurement traceability, sampling and much more.

Recording Available

 

Method Validation: Yesterday, Today and Tomorrow

webinar-speaker   Steven Walfish

webinar-time   60 Min

Product Id: 705439

This webinar will focus on analytical method validation and its evolution to be a risk based process using statistical concepts. The idea of an Analytical Target Profile (ATP) in the context of target measurement uncertainty (TMU) will be explored.

Recording Available

* Per Attendee $279

 

Using Records to Identify Root Causes of Non-Compliance

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 705345

This webinar will discuss the use of records to identify root causes of non-compliance in GLP or ISO 17025 compliant laboratory.

Recording Available

 

Laboratory Accreditation and Quality Management Systems Part 1: Management Concerns

webinar-speaker   Michael Brodsky

webinar-time   90 Min

Product Id: 705298

This training program will cover the requirements of ISO/IEC 17025 laboratory accreditation standard. It will focus on management components of QMS including document control, quality system, service to customer, internal audits and much more.

Recording Available

 

FDA Inspections: What Regulations Expect

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705346

Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.

Recording Available

* Per Attendee $249

 

Do you use Ion Chromatography?

webinar-speaker   John Fetzer

webinar-time   90 Min

Product Id: 705290

This webinar will cover in detail the various ion separation methods, their strengths, weaknesses, and applicability to various analytical problems and sample types. It will also include a discussion on ion detection and especially the area of ion suppression for electrical-conductance detection.

Recording Available

 

Calibration and Qualification in Analytical Laboratories

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 701548

This webinar will provide a detailed understanding about calibration and qualification of laboratory equipments, development of a qualification master plan, allocation of equipments to qualification categories A, B, C, and the approach for qualifying existing systems.

Recording Available

* Per Attendee $279

 

How to Transfer Non-Compendial and Developed QC Procedures - ICH and USP Guidelines

webinar-speaker   Barbara Berglund

webinar-time   90 Min

Product Id: 701845

This webinar will explain ICH and USP guidelines for validation and how to apply ICH guidelines for method transfer and how to establish boundaries.

Recording Available

* Per Attendee $249

 

 

 

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