Drugs / Biologics

Teri C. Soli

Water System Biofilm Control and Microbial Monitoring Myths
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
Live Tuesday, May 22, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Jeff Schwegman

Lyophilization Process Development and Cycle Design with a Case Study
This webinar will cover the process and benefits of using an empirical approach to design an optimized lyophilization cycle. In the past, a "trial and error" approach was routinely used as the means of cycle design, often resulting in products that were substandard or cycles that were prohibitively long and expensive.
Live Thursday, May 24, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Dr. Ludwig Huber

Validation of Analytical Methods for FDA Compliance: Step-by-Step
Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
Live Thursday, May 24, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes

$245.00

Steven Walfish

Using Statistics to Determine Sample Size
This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.
Live Tuesday, May 29, 2012 12:00 PM PDT | 03:00 PM EDT, Duration:60 Minutes

$245.00

Joy Frestedt

Risk-Based Monitoring of Clinical Trials: Say Goodbye to 100% Source Document Verify
The presentation reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
Live Tuesday, May 29, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

David Nettleton

Computer System Validation: Step-by-Step
This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project.
Live Thursday, May 31, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes

$245.00

David Nettleton

Excel Spreadsheet Validation to Eliminate 483s
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
Live Tuesday, June 5, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes

$245.00

Teri C. Soli

Leadership in Manufacturing Contamination Control
The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise.
Live Tuesday, June 5, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Jasmin NUHIC

Effective Corrective and Preventive Actions (CAPA): 10 Steps
This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success.
Live Thursday, June 7, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Jeff Schwegman

Residual Moisture Testing of Lyophilized Products
This webinar will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods. Understanding the different techniques, their limitations, and proper execution will result in more accurate and precise moisture results, which translates into better quality products with longer shelf lives.
Live Tuesday, June 12, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Dr. Efrem H. Zaret

GMP Compliance for Dietary Supplements
The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements.
Live Wednesday, June 13, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

Angela Bazigos

Excel Spreadsheet Validation for FDA 21 CFR Part 11
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Live Thursday, June 14, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

John G. Lanese

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations
Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations.
Live Tuesday, June 19, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Jose Mora

Design Inputs - Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
Design Inputs, Design Outputs, and Traceability matrices present a challenge to almost all industries that apply design controls. Typically, these cause the creation and maintenance of duplicate information across various documents - a major source of errors. This webinar applies the Theory of Lean Documents and the corresponding Theory of Lean Configuration to avoiding these errors, while presenting a fresh new approach to these key and related documents.
Live Tuesday, June 19, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

David Nettleton

Risk Assessment - Compliance Using Easy To Fill Out Documentation
This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance.
Live Wednesday, June 20, 2012 10:00 AM PST | 01:00 PM EST, Duration:75 Minutes

$245.00

Dr. Ludwig Huber

IT Infrastructure and Network Qualification: Step-by-Step
Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With this legislation IT infrastructure and network qualification and compliance become a much more recognizable issue at higher levels of management.
Live Thursday, June 21, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes

$245.00

Jeff Schwegman

Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products
Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing. Cycles that have been designed on development-scale equipment, and are producing acceptable product, can suddenly start suffering from both physical and chemical instability when scaled-up to a larger freeze-dryer, or transferred between production freeze-dryers.
Live Tuesday, June 26, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Kerry Paul Potter

FDA Inspections - Do's & Don'ts
The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that your products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful inspection is being prepared to communicate how your quality systems assure this state of control.
Live Wednesday, June 27, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

David Nettleton

GxP Computer System Validation, The investigator's Point of View
The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors.
Live Tuesday, July 10, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes

$245.00

Kerry Paul Potter

Good Documentation Practices for GMP Operations
Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance. To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory employees must follow good documentation practices.
Live Wednesday, July 11, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:60 Minutes

$245.00

Dr. Ludwig Huber

Effective Training Practices for FDA Compliance
No or inadequate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations are, their interpretations and expectations of inspectors.
Live Thursday, July 12, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:75 Minutes

$245.00

Jeff Schwegman

Container Closure Systems and Bulk Freeze-Drying
This webinar will start by covering ways to understand the physical properties of our formulated products through the use of very specialized analytical techniques.
Live Tuesday, July 17, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Steven S Kuwahara

GMP for Phase 1 Products
This presentation will cover the contents of the guidance that was given. FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP.
Live Tuesday, August 7, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

Steven S Kuwahara

Statistical Procedures Needed for Compliance with the Guidance on Process Validation
This guidance document contains several statements that make it clear that statistical procedures will be expected. Recently, FDA issued new draft guidance on process validation. When finalized, it will supersede the previously issued guidance documents on process validation. It is expected that the final guidance will not be much different from the draft.
Live Thursday, September 6, 2012 10:00 AM PDT | 01:00 PM EDT, Duration:90 Minutes

$245.00

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