Effective Commissioning supports engineering and Qualification success. This webinar addresses the basics of Commissioning and Qualification for the Pharmaceutical and Biotechnology industries and discusses efficient Commissioning techniques and synergizing with Qualification. The presenter has been a leader in the Pharmaceutical industry in the application of documented Commissioning to minimize the regulated paperwork required for Validation/Qualification. He shares his learned experiences in this course in the practical application of commissioning as it specifically relates to Pharmaceutical projects.
Commissioning as it relates to the Pharmaceutical industry is examined. Include are discussions on the following:
Commissioning streamlines Qualification
Validation/Commissioning: the Distinctions
The "W" Model
Establishing Commissioning and Documentation Requirements
Commissioning Test Plans
SMART Commissioning and Qualification Acceptance Criteria/Ranges and
The textbook definitions of this effort are fairly easy to understand. However, knowledge and application are often very hard to align. This course is an introduction to the "Real World of Project Management" as it relates to Commissioning and Qualification, and focuses primarily on lessons learned by an experienced project manager in the successful (and sometimes not so successful) completion of capital projects in the regulated industries of pharmaceutical and biotech manufacturing.
Why should you Attend: Application of project management knowledge is often difficult for young or inexperienced project managers. The "Real World of Project Management" series of webinars presents the information in a unique structure of its application to real projects. Anyone involved in capital project delivery, and especially those that have the additional constraints of quality and safety on their projects, will find this webinar valuable. This webinar is beneficial to anyone who needs exposure to Commissioning and Qualification for the first time, anyone who needs a refresher on the basics or anyone who needs real world knowledge on managing this type of work.
Areas Covered in the Session:
What is Commissioning and how does that definition apply to regulated industry
What is Qualification, and how does that differ from Verification or Validation
What are the benefits of a structured C&Q campaign
When do you apply these types of programs
Who should do the work
Where industry was before ASTM e2500
Where is industry going
Why bother in the first place?
Who Will Benefit:
Keith Gibbs is the Corporate Manager of Technical Services, Commissioning and
Qualification for Yonkers Industries, Inc. In addition, he serves as Chairman of the ISPE Project
Management Community of Practice and served as a Core Team Member and Author of the ISPE
Project Management Good Practice Guide. Mr. Gibbs is also an Instructor for the North Carolina
BTEC Validation Academy, teaching Project Execution Planning for Commissioning and
Qualification and Introduction to Maintenance Management. Mr. Gibbs is a highly-motivated leader with a proven project management track record. Able to interface with and motivate people at all levels of an organization or project and across all business units, he works diligently on the application of best practices. He possesses an extensive experience organizing and supervising the business activities of project teams, within budget and to tight timetables. An innovative thought leader who is well respected by industry peers for creative and applicable solutions to complex problems, he has proven planning and brainstorming expertise that has established a framework for successful projects and business practices. Mr. Gibbs is a sought-after trainer and educator who has a gift for motivating fellow professionals to reach their peak performance. Through many years of in the field experience, he possesses a full and applied understanding of the business of consultancy support to industry.
As the owner of Ninja Project Management, Mr. Gibbs relies on his eighteen (18) years of experience in Project Management, Engineering, Construction Management, Commissioning & Qualification (Verification), Validation, Quality Assurance, and Pre-Operations Management Support for the pharmaceutical, biotechnology, semiconductor and utility generation and transmission industries, to help clients succeed. Typically, responsible for the management of cGMP or specialty projects that involve start-up, commissioning, qualification and validation, he is best utilized for short-term, fast track, complex projects. His greatest strength is applying his expertise to projects that need to be brought back on track, and he is a recognized leader for project salvage and restoration planning. To support these tasks, he is involved in the preliminary design review, constructability review and master planning activities to ensure the integration of all phases of a project in the support of turnover, start-up, Quality Assurance and Validation requirements. In his career, he has managed the design, installation, start-up and qualification of utility, facility, control and process systems for laboratories and pharmaceutical manufacturing facilities. A leader in the integrated approach to commissioning and qualification, he has extensive experience in authoring and executing test plans and protocols. A unique specialty is the development of leveraged Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) plans as part of integrated Commissioning/Validation efforts. Another hard-earned specialty is the extensive experience in deviation resolution.
Mr. Gibbs has managed teams from 2 to 40 direct reports on projects from $50,000 to $50,000,000. He has supported innovative projects with full life-cycle involvement, as well as task focused short cycle assignments. Primary goal: Identify needs, plan a solution and execute successfully.
In his free time, he runs a small business, Raleigh Llama Salvage and Restoration, where he seeks out and restores items and artefacts of interest to him. He is an avid disc golfer and enjoys time with his family.