2013 October New Brunswick Training2013 October New Brunswick Training2013 October New Brunswick Training

Education Details

Training Courses are two-day events that are a great place for your employees to work interactively with industry experts and peers to gain valuable skills and knowledge. Our instructors work in the industry and face the same daily challenges you do. Training Courses are:

7 – 8 October

Auditing for GMP (G07)
Instructor:Jeri Weigand, Senior Principle Quality Specialist, Medtronic

Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.

Facility Project Management (T26)
Instructor: Jeffery Odum, MS/EM, CPIP, Biotech SME, Operations Manager, Integrated Project Services – IPS

This course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits and provide tools to manage all project resources.

A Risk-Based Approach to GxP Process Control Systems: Applying the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition) (T21)
Instructor: Mike Byrd

Through interactive workshops, this course will explain and apply the science and risk-based approach to verification of systems, equipment and facilities in accordance with the ICH documents Q8, Q9, and Q10 and ASTM E-2500.

9 – 10 October

Q7A: Implementing Good Manufacturing Practices (T30)
Instructor: Jack Chu, Manager of Technical Support, EM&U-BTM Operations/Commercialization at West Point, Merck & Co., Inc.

This course reviews and interprets the key GMP requirements specific to bulk biopharmaceuticals and familiarizes participants with the USFDA's interpretation of ICH Q7, as defined in Q7A, the Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

An Overview of Biomanufacturing Processes (T24) Course includes webinar
Instructor: Mark Witcher, Principal Consultant for IPS – Integrated Project Services

This course provides an overview of biotech manufacturing processes used to make biopharmaceuticals. Discover the underlying principles of proteins and cells which will provide a basic understanding of how and why the processes manufacture therapeutic proteins.

Sterile Product Manufacturing Facilities: Applying the new ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation (T12)
Instructor: Mark von Stwolinski, Vice President Architectural Services, Clark Richardson & Biskup (CRB) Consulting Engineers

This course uses the newly published second edition of the ISPE Baseline® Guide: Sterile Product Manufacturing Facilities and the FDA's newly published Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice to provide an understanding of the key requirements and GMPs for sterile manufacturing facilities.

Course includes webinar This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course.

Continuing Education Units (CEUs)

ISPE will provide continuing education units (ISPE CEUs) for all North American courses. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials.

Certified Pharmaceutical Industry Professional™ (CPIP™)

Some courses contain knowledge related to the CPIP™ Technical Knowledge and Competency Elements. For complete information concerning the knowledge elements or the CPIP™ Credential, please visit www.ISPE-PCC.org. The ISPE Professional Certification Commission does not endorse any of these resources, products, or services offered relative to the CPIP™ certification program.

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