Jim Polarine

Current Industry Best Practices in Disinfectant Validation

Designing an effective disinfectant validation program to meet FDA, MHRA, HPRA, EMA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Current 483's, Warning Letters, European Regulations, and Field Experiences as well as case studies will be conveyed that allow end users to determine that best methods to validate their products against their environmental isolates. Current industry best practices will be covered as well as potential pitfalls that can occur during testing.

Teri C. Soli

Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems

Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.

Susan Rocca

Quality Management Systems - Creating, Implementing and Improving

Today's manufacturers face enormous challenges managing their quality and compliance initiatives. Market trends point to even greater scrutiny of these efforts as pressure mounts from both consumers and regulatory agencies for manufacturers across a broad range of industries to deliver better, safer products and services. To meet these important regulatory challenges, it is imperative that manufacturers have a quality management system to manage processes and provide timely access to relevant data, effectively and efficiently.

Kim Huynh-Ba

Impact of Good Documentation Practices on Compliance Activities

Key components of documentation and record management system will be introduced. Regulatory requirements will also be discussed as the basis of documentation standards. It will also cover different types of records and how it would affect quality systems.

John N. Zorich

Better Alternatives to Sampling Plans

The webinar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

Denise Mainquist

PCI DSS: Tips and Trends for 2010

Compliance to the PCI DSS can be an overwhelming task in the beginning. The requirements are specific and if your organization has not had an information security program in place, there may be a lot to do to meet minimum compliance requirements.

Melinda Allen

Webinar on Allergen control

Allergens under regulatory control are limited to 8. However, they take on many names and forms. Identifying and avoiding these allergens are an important strategy for manufacturers as well as consumers.

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