Pack of FIVE: Best Selling Lab Related Webinars by GlobalCompliancePanel

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Pack of FIVE: Best Selling Lab Related Webinars by GlobalCompliancePanel

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Webinar Packs	:	Pack of FIVE: Best Selling Lab Related Webinars by GlobalCompliancePanel
Product Id	:	30121PACK

Modules:

GMP Expectations for Products Used in Early Phase IND Studies
Understanding Analytical Test Results: Comparing Two Sets of
Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation
Validation of Analytical Methods and Procedures
Risk-Based Validation of cGMP Systems

Instructor : Steven S Kuwahara

Product Id : 30121PACK

Webinar# 1

GMP Expectations for Products Used in Early Phase IND Studies

Overview: FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned. This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements.

Areas Covered in the Session:

Discussion of the elements found in the guidance document for Phase 1 material.
What to do at really early stages.
What about special IND studies?
What about preclinical studies?
Varying GMP activities that depend upon the nature of the IND product.
What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
What to do about QC activities such as instrument qualification, method validation, and process validation.

Who Will Benefit: This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying types of GMP activities that accompany early stages of Product development.

Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions.
QA/QC personnel who need to plan work on early stage material
R & D personnel who will contribute data to CMC sections.
Project managers for product development studies.
Quality systems auditors
Consultants

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

Instructor : Steven S Kuwahara

Product Id : 30121PACK

Webinar# 2

Understanding Analytical Test Results: Comparing Two Sets of

Overview: The class will cover the understanding the properties of single test results and how they may be compared.

There are many problems that arise from a misunderstanding of the properties of single data sets and the problems are compounded when data sets are compared. The discussion will cover the misconceptions and present methods to allow proper comparisons, while considering the risks inherent in decisions based on analytical data.

Areas Covered in the Session:

Averages and their properties that affect decision making.
The proper way to compare averages.
The selection of sample sizes with the attendant risks.
The interaction of variation and sample sizes.
How to compare the variation observed in two different data sets.
How to make predictions of intervals for future data, and the use of these predictions for setting specifications.

Who Will Benefit:

Workers in Quality Control Laboratories.
Supervisors of workers who perform analytical testing.
Managers who must make decisions based on analytical data.
Planners who must make predictions of future performance based on current test data.
Reviewers who must understand the relationships among analytical data.

Instructor : Dr. Ludwig Huber

Product Id : 30121PACK

Webinar# 3

Transfer of Analytical Methods and Procedures: FDA Requirements and Strategies and Tools for Implementation

Overview: When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

So far there have not been official guidance on what exactly is expected to maintain 'the validated state'. Now the USP is preparing for a general chapter and the FDA has released an official guidance on how to conduct and document method transfer. The guide has been developed for medicated feed assays but the principles can be applied to other methods. Now it is a good time to learn how to conduct and document method transfer for FDA compliance.

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

Instructor : Dr. Ludwig Huber

Product Id : 30121PACK

Webinar# 4

Validation of Analytical Methods and Procedures

Overview: 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. This seminar will provide a good understanding on how to effectively prepare, conducts and document method validation experiments for FDA and ISO 17025 compliance.

Reference material for easy implementation:

SOP: Validation of Analytical Methods
Checklist: Validation of Analytical Methods
65-page Primer: Validation of Analytical Methods

Instructor : Richard Poser

Product Id : 30121PACK

Webinar# 5

Risk-Based Validation of cGMP Systems

Overview: This presentation will review a methodology for implementing Risk-Based Validation of test equipment, facilities and analytical instruments used in GLP, cGMP and GCP facilities.

A case study is presented for the construction qualification, relocation and new equipment installation for a cGMP facility. The cost and time savings associated with using risk-based validation will be presented. Over 3,000 systems or pieces of equipment were installed or relocated in a short time frame at a substantially reduced cost. A risk-based approach to validation was employed, dramatically reducing the cost and time for facility qualification. Comments by regulatory inspectors will be discussed.

Why should you attend:
How much validation is enough? How much is too much? When should you validate what system? Risk-based validation is the new and FDA-preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.

Richard Poser, PhD is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers, contract manufacturing sites and software developers that support these highly regulated industries. Following an academic career in drug metabolism and chemotherapy, Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. He joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. Following acquisition of Dura by Elan, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team. Now in private practice as a quality consultant, he also lectures at UCSD Extension in validation and has presented or chaired public seminars on cGMP Requirements, Computer System Validation, Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification.

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