May 16-17, 2012 - New Jersey, USA

About this Conference:

Stability requirements for the worldwide registration of pharmaceutical and biopharmaceutical products have changed dramatically in the last few years. A series of guidelines on the design, conduct, and data analysis of stability studies of pharmaceuticals have been published by the International Conference on Harmonization (ICH); however, the statistical discussion on study design is limited.

This event covers stability designs including full, bracketing, and matrixing. The statistical aspects of these stability designs will be discussed in relation to the recent ICH guidelines. The statistical and regulatory considerations on the selection of stability design will also be presented. The stability study should be well designed so the shelf life of the drug product can be estimated with a high degree of accuracy and precision. Several commonly used criteria for design comparison will be presented. Finally, a case study is presented to illustrate the potential problems of an over- reduced design from the statistical and regulatory perspectives.

This event covers advanced characterization technologies for a range of complex therapeutic proteins to provide a fuller understanding of the product, to ensure safety and efficacy, and to facilitate smooth and efficient interaction with the regulatory authorities. It focuses on assay methodology and validation, identification of hot spots for liability, post-translational modifications, impurities, critical quality attributes formulation and stability. There will be a strong emphasis on case studies and practical application.

June 6-7, 2012 | Boston, MA

This seminar presents the FDA Medical Device process including FDA’s three new guidelines on 510(k) submissions. Changes to FDA regulations and guidelines will be reviewed as well as the preparation and processing of 510(k), IDE and PMA submissions. Participants will gain an understanding of the FDA Medical Device process and the underlying scientific and regulatory principles involved. The entire FDA Medical Device process is reviewed from research, to submission to market. Structuring of FDA Medical Device submissions and post approval documents are covered. Information on maintaining FDA relationships is also covered. This seminar enables the participant to provide FDA with the necessary submission information to obtain product approval.

THE PRESENTATION WILL COVER

•Learn about the FDA Medical Device Approval Process
•Preparation of the four types of 510(k)s
•Preparation of an IDE
•Preparation of a PMA

Global Perspectives for Pharmaceutical, Biopharmaceutical and Allied Industries

September 25–26, 2012 - Montréal, QC, Canada

A dynamic two-day of learning, networking, and valuable insight to take back to your organization.

This global themed event has continuously left a lasting impression on its audiences whom have continued to show their support at each conference. This year, we pledge to provide you with an unforgettable experience at the greatest GMP event of the year!

IPA’s 8th Annual GMP Update Conference with a theme “What’s New?”, will provide a platform for you to gain and share valuable information and insight into the major developments in the quality, compliance, validation, and regulatory areas affecting the pharmaceutical, nutraceutical, biotechnology, medical device and allied industries. Whatever, your role and experience, our unparalleled lively presentations will allow for discussions and intimate interactions with top officials from the regulatory agencies and senior industry professionals to address your unique needs? Our diverse panel of experts has delivered, each year, the hottest topics, trends and issues surrounding good manufacturing practices.

Don’t miss your chance to attend this outstanding conference which was “sold out” last year. By securing your seat now with early registration, also receive a complimentary gift from IPA as well as being put into our grand prize draws!

We look forward to seeing you in beautiful Montreal this September

June 4-5, 2012 - Montreal, Quebec, Canada

This two day workshop covers practical examples of using established analytical techniques for protein structural analysis in the areas of biotherapeutics product and process development. We will review the post-translational modifications commonly observed on recombinant proteins produced from manufacturing cells lines and discuss the potential impact of the structural heterogeneities on biological activity. In addition, characterization of higher order structures, aggregates and particulates, binding and cell-based potency assays will be discussed. The impact of bioprocess parameters, including cell line selection, on product quality profile will be reviewed. Examples on characterization of different recombinant proteins including monoclonal antibodies using key orthogonal techniques will be highlighted. The objective is to provide participants with key technical information along with perspectives to enable them to apply the technologies to their own projects and evolve their own analytical strategy to support the various stages of product development.

COURSE OUTLINE:

• Introduction to protein structure and post-translational modifications
• Protein Chemistry Techniques: capillary electrophoresis and HPLC, enzymatic
  methods and peptide mapping, mass spectrometry, amino acid analysis, top-down and 
  bottom-up protein sequence analysis , sample treatment, preparation & work flow
• Biophysical Characterization: spectral methods including vibrational spectroscopy, fluorescence and circular dichroism. Light scattering, calorimetry, analytical ultracentrifugation, atomic force microscopy, and field flow fractionation techniques. Aggregation, subvisible and visible particles analysis
• Characterization of recombinant protein products: glycosylation analysis; monoclonal antibody structure and subclasses, additional recombinant proteins, product heterogeneity analysis
• Bioprocess impact on product quality: cell line selection, upstream process variables, downstream process impact, formulation/fill/finish and storage
• Quality control of biotechnology products: guidance documents
• Process control strategies: Quality by Design and process development, process transfer, comparability considerations. Selecting characterization methods to support early vs. late stage product development

June 5-6, 2012 - Toronto, Canada

The usage of utilities, equipment, systems and processes within a GXP environment require the documented evidence that these items operate according to their design criteria, within defined acceptance criteria and achieve them on a consistent basis. The use of qualification protocols is the method of verifying and documenting these requirements and this course will look at what they should include, how to properly document results obtained, the final reports used to summarize the results and how to address any deviations incurred. While the level of detail associated within these documents can vary significantly between companies, this course will present a general template that can be used to help companies develop their own based on corporate expectations and current industry practices. This class will cover the life cycle approach to qualification including the various topics:

• Review of regulatory requirements for qualification practices
• Development of a validation master plan to help set corporate expectations with regards to the approach used, typical acceptance criteria, testing procedures, etc.  
• Review of the typical contents for each protocol type
• Discuss common regulatory deficiencies cited for each of the various protocol types
• Review the requirements for change control and what should be covered in both a procedure and forms used to document changes.
• Discuss the topic of re-qualification in terms of what should be done, how often and other approaches used by industry.
• Review regulatory expectations for deviations and their impact on qualification testing

Participants will be given an actual IQ/OQ template to review for a piece of equipment and discuss questions related to the contents. Participants will also be given an example of an item to qualify and will openly discuss what topics and test challenges would be expected. The course will be a combination of lectures, questions, open discussions and class exercises where everyone will be given a chance to address any specific concerns they may have to their own qualification approach.