WEBINARS

 

Laboratory Documentation and Data Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

7 / Dec / 2021 - Tuesday

* 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   90 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

 

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

 

Measurement Uncertainty in Microbiology

webinar-speaker   Michael Brodsky

webinar-time   60 Min

Product Id: 703902

This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.

Recording Available

* Per Attendee $249

 

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Recording Available

* Per Attendee $299

 

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

 

Where FDA Is Heading in Regulating Laboratory-Developed Tests

webinar-speaker   Dennis Weissman

webinar-time   60 Min

Product Id: 705335

The webinar will cover the federal regulatory approach to regulating laboratory-developed tests including the role of CLIA, the rationale for and opposition to direct FDA oversight, the goal of possible federal legislation and the prospects for future action by the FDA and/or Congress.

Recording Available

* Per Attendee $249

 

Software Validation and its 11 Key Documents

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 703097

This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.

Recording Available

* Per Attendee $299

 

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation and Transfer

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 703644

This training on using the QbD approach to analytical method lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements. The webinar presenter will use case studies to illustrate each stage in the process.

Recording Available

* Per Attendee $299

 

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

 

Current Concepts and Challenges in Cloud Compliance

webinar-speaker   Angela Bazigos

webinar-time   90 Min

Product Id: 703739

Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.

Recording Available

* Per Attendee $299

 

Data Governance for Computer Systems Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 704745

In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.

Recording Available

* Per Attendee $249

 

Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration

webinar-speaker   Jose Mora

webinar-time   90 Min

Product Id: 703396

This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to controlled document system for a life sciences manufacturing plant.

Recording Available

* Per Attendee $249

 

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

 

Validation and Use of Cloud Computing in FDA Regulated Environments

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 703423

This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.

Recording Available

* Per Attendee $249

 

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

 

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

 

System Suitability Testing (SST) for USP and FDA Compliance

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 702512

Amid several other critical discussions, this training program will detail FDA and international requirements for system suitability testing; SST in comparison with equipment qualification and quality control sample analysis; critical parameters for SST in EP and USP; recommendations for implementing the updated <621>; and developing an SOP for system testing.

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

 

 

 

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