The successful delivery of manufacturing facilities , including small, large, new, expansion, or renovation type projects regulated by various authorities, poses significant challenges to manufacturers, engineering professionals, and equipment suppliers. These facilities are required to meet all applicable GxP regulations, and to comply with all other relevant local and international governing codes, laws, and regulations. This classroom course is designed to improve the way in which the industry delivers regulated manufacturing capacity: improving the ability to meet documented process requirements, control risks within the manufacturing process, produce high-quality products and consistently operate to meet product and process requirements. Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory. Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach to Quality Risk Management.
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Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning and Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2 nd Edition Guide, ICH documents Q8 R2 , Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E Guidance is provided how to transition an organization's approach quality systems and establishing the appropriate of level of quality oversight for Commissioning and Qualification that incorporates a science and risk-based approach.
NOTE: It is strongly recommended that participants be familiar with basic concepts of commissioning and qualification prior to attending this course. This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course.
Access information will be provided via email one week prior to the start of the training event. Intermediate practitioners of Commissioning and Qualification who want to understand and use the Science and Risk-based approach.
Project engineers, project managers, commissioning and validation professionals, engineering service providers, and quality assurance personnel involved in qualification and validation and regulatory. Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18, pharma professionals from around the world by becoming an ISPE Member. This course is not currently scheduled, but may be offered at your company site.
Please contact ISPE for more information. Commissioning and Qualification. ISPE Membership Benefits Become a member today Gain the knowledge and competitive edge you need to succeed in the pharmaceutical and biopharmaceutical engineering industries and join more than 18, pharma professionals from around the world by becoming an ISPE Member.
Baseline Guide Volume 5: Commissioning and Qualification (Second Edition)
The guide was first issued in and reflective of that time. With emerging markets, changes in the regulatory This Guide provides practical guidance on the implementation of a science and risk-based approach for the commissioning and Baseline Guides. Good Practice Guides. Published: July Pages: Table of Contents Special Pricing for Emerging Economies Water and steam may be used in the manufacture of products, cleaning operations, and laboratory activities within pharmaceutical or biopharmaceutical operations.
Commissioning and Qualification
Recent developments, e. Adjustments to the state of the art were made in the past by means of " bridges ". The new document is very extensive with a total of pages. The Baseline itself contains "only" pages, though. The remaining pages contain 17 appendices with references to the regulations, sample documents, references and a glossary. Appendix 15 describes the handling of legacy systems or systems with inadequate qualification. The Baseline itself is divided into 14 chapters:.