WEBINARS

 

Good Laboratory Practice 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

 

Root Cause Analysis (RCA) in the Laboratory - Addressing Non-Conformances

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 704861

This RCA webinar will define a specific set of steps and associated tools that you can use to determine the primary cause of non-conformance in your laboratory. You will learn to determine what happened, why it happened and how to reduce the likelihood of that non-conformance happening again.

Recording Available

* Per Attendee $249

 

Validation of HPLC/UPLC Methodologies

webinar-speaker   John Fetzer

webinar-time   60 Min

Product Id: 705291

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Recording Available

* Per Attendee $249

 

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

 

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 $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

 

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

 

The Most Serious FDA 483s - How to Avoid Them

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 702766

This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.

Recording Available

* Per Attendee $299

 

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 702534

This 2-hr laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.

Recording Available

* Per Attendee $299

 

Assay Validation for Clinical Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 702872

This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.

Recording Available

* Per Attendee $249

 

Ensuring Integrity and Security of Laboratory Data

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 702454

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and 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

 

Laboratory Accreditation: Getting there is Just the Beginning

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 703285

This training on laboratory accreditation will focus on ISO/IEC 17025 requirements. Attendees will learn how to develop and maintain a quality management system to ensure compliance with the international laboratory accreditation standard.

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

 

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

 

Managing GLP Studies in Non-GLP Facilities

webinar-speaker   Anne E Maczulak

webinar-time   90 Min

Product Id: 702342

This 90-minute webinar will help you understand when a new product being developed begins to fall under the umbrella of a regulated study, teach you the basic principles of GLP study to better separate regulated activities from basic research, provide practical tips on how to keep GLP-related materials separate from non-GLP materials, and manage equipment designated for GLP use.

Recording Available

* Per Attendee $199

 

Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom

webinar-speaker   Jim Polarine

webinar-time   90 Min

Product Id: 705078

This 90-minute webinar will cover general considerations for microbial control for non-sterile manufacturing areas, including attributes of an effective cleaning and disinfection program. Points to consider specifically aimed at oral solid dose (OSD) manufacturers will also be presented, including cleaning and disinfection of both product contact and non-product contact surfaces.

Recording Available

 

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 705072

This webinar you will discuss how to help your organization get a better handle on what is an “objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to minimize the risk if you find one in your process or product.

Recording Available

* Per Attendee $249

 

 

 

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