Extractables and Leachables Requirements in Pharmaceutical Development

About this course

This course will provide an overview of E&L with regard to pharmaceutical packaging/container closure systems, processing equipment and devices for drug products including biologics. We will review the regulatory framework and explain why this area is getting so much attention. You will learn about material selection and the risks certain materials present from an E&L standpoint. You will also gain insight into the best practices for E&L testing.

The PQRI Working Group best practices for ‘Orally Inhaled and Nasal Drug Products’ was published in 2006. A similar process is being conducted by PQRI for ‘Parenteral and Ophthalmic Drug Products’ and preliminary approaches were presented in an open forum in February 2011. The course will compare and contrast elements of these best practices.

E&L studies generally apply to the selection of components and evaluating changes in components or in their use. This course will also illustrate the importance of routine E&L control.

The course format will be lecture and casework to involve the participants in tackling real E&L issues and discussing solutions.

The course will be of value to development scientists, development engineers, validation scientists, quality control analysts and individuals with quality control and quality assurance responsibilities. Suppliers of components for device manufacturers and disposable biological systems will gain valuable insight. Both N1 and N2 suppliers will benefit. Anyone with E&L project oversight and questions on best practices will benefit by attending this course.

Course outline

• Materials overview
• Where is the E&L risk considered to be highest?
• Regulatory and industry guidelines
• Limitations and challenges of analytical methods
• Timelines required for E&L analysis
• Strategies employed by companies
• Analytical methods and protocols
• Best practices employed for E&L study

Discussion and Working Groups

A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.

Additionally, discussion periods, provide delegates with an opportunity to obtain answers to their specific questions and concerns.

Venue

San Mateo Marriott San Francisco Airport, San Mateo, CA, USA

The San Mateo Marriott San Francisco Airport Hotel is is located just 10 minutes from San Francisco International Airport and offer complimentary shuttle service. It has convenient access to San Jose and San Francisco and is also less than 30 minutes from the Golden Gate Bridge.

Hotel Accommodation

NSF-DBA has negotiated a preferred rate with the San Mateo Marriott San Francisco Airport Hotel. A limited number of rooms are available at this rate. Hotel
reservations and payment are the responsibility of each delegate.
We will be happy to help but final confirmation and bill settlement
is the delegate’s responsibility.

Venue Address and Contact Details

San Mateo Marriott San Francisco Airport Hotel,
1770 South Amphlett Blvd,
San Mateo,
California 94402,
USA,

Tel: 1-650-653-6000~

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our expert for this course is:

• Dr Michael Ruberto

Dr Michael Ruberto is the President of Material Needs Consulting, LLC and a retained consultant of NSF Pharmalytica. He provides consulting services to manage the development and commercialization of medical devices and packaging, with a special emphasis on material selection, extractables and leachables, and supply chain management. He has been an active member of various pharmaceutical working groups that have developed ‘best practices’ for characterizing and evaluating the safety of container closure systems and packaging for several different drug dosage forms.

Dr Ruberto was formerly the Head of Regulatory Services for North America at Ciba Specialty Chemicals where he was responsible for worldwide notifications of new products, food contact notifications and regulatory compliance of Ciba chemicals. He was also the Director of Analytical Research for Ciba where he designed leachable and extractable studies for the FDA approval of medical devices, packaging and labels used on drug containers.

What you've said

“Mike is very knowledgeable in the subject matter. I learned a great deal.”

Staci Gilchrist, Smiths Medical, USA

“It was a lot of information in one day, but it was summarized in an organized and concise manner.”

Kristin Wall, Cubist Pharmaceuticals, USA

“This programming with the information I will get from my vendors, I feel confident that I can now conduct an adequate E/L program for our NOA.”

Jacqueline Walsh, Cubist Pharmaceuticals, USA