This Quality Practices for R&D CMC Laboratories training will associate with generating, reviewing, utilizing or contracting analytical studies for pharmaceutical product development.
Why Should You Attend:

During product development, many experimental CMC studies to support process development and product characterization are conducted in non-GMP laboratories, including academic and contract facilities. However, the data generated in these studies may be utilized in product regulatory filings, making them subject to concerns about traceability and reproducibility. While there are no formal compliance requirements for R&D laboratories, emerging regulatory concepts in quality systems and quality by design place greater compliance pressure on R&D labs for sound scientific practices. Additionally, early-phase quality control testing may be performed in laboratories that are not fully GMP compliant, and are in fact much closer to R&D than GMP.

• A large number of CMC studies to support product development are not required to be performed in GMP laboratories.
• Data from supportive CMC studies are typically presented in regulatory dossiers which makes them subject to later review and verification.
• Lack of adequately documented early development data often becomes a cost factor for in-licensed products.
• Quality practices at academic and contract testing laboratories can greatly impact the utility of their CMC data.
• Some analytical laboratories erroneously interpret GLP as 'GMP-light'.

Areas Covered in the Seminar:

• What is the economical impact of poor quality R&D CMC data in product development timelines and costs?
• What laboratory studies are required to be performed under GLP vs GMP?
• What quality practices are expected for non-GMP/non-GLP laboratories where the data generated are used in regulatory filings?
• What are the key-process related CMC activities.
• what are Key Analytical and QC CMC Activities.
• what is good CMC practices and how to ensure CMC quality is consistently implemented.

This 90-minute webinar will clarify your confusion about Test Article Characterization for GLP drug studies. You will learn the correct way to use GMP characterization data in a GLP study, understand how to characterize a medical device as a test article, learn the common mistakes made in test article characterization and the basic requirements for drug and device stability testing.

Why Should You Attend:

The presentation will begin with a review of GLP requirements for test and control article characterization, regardless of whether the article is a drug or device. It will address the study director's responsibilities and sponsor responsibilities in test article characterization. Attendees will learn the best practices for managing GMP characterizations, stability, and certificates of analysis. Special attention is given to the testing that must be performed to show that no test material carried over into control materials. Carryover has become one of FDA’s target areas in recent years because of the serious effect it has on drug safety results. The presentation treats carryover as a special topic in test article/control article characterization. The presenter also emphasizes the importance of control article characterization.

Areas Covered in the Seminar:

• What are the recommended procedures for chemical and physical characterization of drugs/devices in safety testing.
• What are the basic requirements of test article characterization.
• How to manage carry-over from test to control article
• How to use GMP test article characterization and the certificate of analysis for a GLP study
• How to define a device test article
• How to characterizing medical devices
• Stability testing for drugs and devices
• How to document test article usage and distribution

Event Details:

Date: September 11, 2012
Time: 10:00 AM-11:30 PM PDT
Cost: $249 per attendee per computer terminal
Registration: SIgn-Up on-line now. Add to your shopping cart.

This webinar will provide a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation. You will learn steps towards laboratory accreditation and how to prepare for an ISO 17025 audit.

Why Should You Attend:

ISO 17025 is used by laboratories as a standard to develop and establish a Quality System and for the assessment by their clients or by third parties. The standard is also being used as a criterion for laboratory accreditation. ISO 17025 is applicable to all organizations performing tests and/or calibrations, regardless of the number of personnel or the extent of the scope of testing and/or calibration.

This webinar gives a detailed information on the critical requirements of ISO 17025 and recommendations for cost effective implementation.

Hand-Outs:
For easy implementation, attendees will receive

• Laboratory Quality Manual: Template and examples
• ISO17025: Step-by-step implementation

Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.

Areas Covered in the Seminar:

• Benefits of ISO 17025.
• Management requirements.
• Technical requirements.
• Documentation requirements.
• Steps towards ISO 17025 laboratory accreditation.
• Preparation for an ISO 17025 Audit.

This 6-hr virtual seminar will review analytical procedures used in assessing quality, safety and efficacy of drug products. It will cover the ICH and USP guidelines for procedure validation and help you ensure robust validation of analytical procedures for drug substances and products.

Why Should You Attend:

This 6-hr training will examine the analytical tools used throughout a drug product life cycle. There is a broad range of assays and techniques used to measure the quality, safety and efficacy of a drug substance or a drug product. The training will challenge attendees to give thoughtful evaluation of their current strategies or to develop strategies from the ground up. The CFR regulations and guidance from the USP and ICH will be used as references and in support of creating a sound approach to the validation of analytical procedures for drug substances and products.

In this 2-hr webinar you will learn how to differentiate and draw boundaries for GMP and GLP practices if done in same laboratory and how to transition a procedure in development to one used routinely.

Why Should You Attend:

If a laboratory is dedicated either to GMP testing and validation activities or to method and procedure development and validation, then the laboratory is responsible for following the appropriate CFRs. GMP guidance’s for the pharmaceutical industry are included in 21 CFR, and for GLP guidance’s can be found in 58 CFR. However, if both types of work are being done in the same laboratory and even by the same analysts, it is critical to define boundaries. This involves not only the analysts and the laboratory management but extends to reviewers of critical documents and client education regarding the practices and policies.

Attend this 2-hr presentation webinar with your team to understand the pitfalls and risks of having GMP and GLP practices occurring in one location and strengthen the understanding of the lifecycle of a method or procedure.

Why Should You Attend:
In this seminar, the application of the terms GLP and GMP will be explored, as there is often confusion in their application during development. This seminar will define the terms and their application in the development environment.

During product development within an organization that has yet to commercialize a product, the use of the terms GLP and GMP are often confused and may be used incorrectly. Doing so can result in reducing credibility by regulatory health authorities. The objective of this seminar is to define the terms, how they are.

Areas Covered in the Seminar:

• Nomenclature.
• How the GLPs and GMPs came to be an their evolution.
• The major sections of GMPs.
• When to apply GMPs.
• The major sections of GLPs.
• When to apply the GLPs.
• A comparison of the two.
• Avoiding confusion.

Why Should You Attend:

China has been improving its regulatory regime governing the food and pharmaceutical industry in recent years. In 2010, by promulgating the amended GMP and amending GLP, GCP, GSP and other regulations, China will further align the country with international standards of practice. For manufacturers and distributors of drugs and medical devices in China, it is important to pay close attention to the pace at which SFDA implements these changes and to make changes to their standard operating procedures when necessary to ensure compliance with the evolving regime.

This 6-hr course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in China. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in China. Content will also include descriptions of the methods by which regulators in the SFDA process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

Why Should You Attend:

In this seminar, the application of the terms GLP and GMP will be explored, as there is often confusion in their application during development. This seminar will define the terms and their application in the development environment.

During product development within an organization that has yet to commercialize a product, the use of the terms GLP and GMP are often confused and may be used incorrectly. Doing so can result in reducing credibility by regulatory health authorities. The objective of this seminar is to define the terms, how they are.

Areas Covered in the Seminar:

Nomenclature.
How the GLPs and GMPs came to be an their evolution.
The major sections of GMPs.
When to apply GMPs.
The major sections of GLPs.
When to apply the GLPs.
A comparison of the two.
Avoiding confusion.

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.

Why Should You Attend:
We saw a significant increase in the number of warning letters in 2009 and 2010 and 2011 is expected to bring in an even larger set of changes as FDA continues to cope with the huge increase in the number of overseas drug manufacturers. This comprehensive webinar will begin with a review of recent warning letters related to the GLPs and a discussion of the focus areas of the inspectors. The discussion will be followed by a review of each of the key GLP systems with an emphasis on the Analytical Laboratory Systems. Common pitfalls in the implementation of the GLPs will be addressed during the discussion related to each area.

This highly interactive course will include detailed discussions of current regulatory expectations and is therefore suitable for individuals new to the pharmaceutical industry and also serves as a refresher course for others. It also has an emphasis on recent inspection trends and will therefore be of interest to the experienced pharmaceutical laboratory professional.

Why Should You Attend:

If a laboratory is dedicated either to GMP testing and validation activities or to method and procedure development and validation, then the laboratory is responsible for following the appropriate CFRs. GMP guidance’s for the pharmaceutical industry are included in 21 CFR, and for GLP guidance’s can be found in 58 CFR. However, if both types of work are being done in the same laboratory and even by the same analysts, it is critical to define boundaries. This involves not only the analysts and the laboratory management but extends to reviewers of critical documents and client education regarding the practices and policies.