Management Training and Staff Qualifications


November 10th, 2021

11:00 AM – 12:00 PM EDT

“Operationally Ready” (aka Vertical Start-up in some industries).  Two words that have a big meaning but are hard to attain in an efficient and cost-effective manner.  As described in Operational Readiness-The Precursor to Operational Excellence, “in practice vertical startups are rare” because management teams typically focus their attention on the installation of the facility, utilities, and the equipment. While equipment and facilities are certainly important, they represent only one of the 3 P’s (Production equipment, People, Procedures).  The most important component, that with the largest variability, is the people, so a large part of the Operational Readiness model is people.

When designing for operation readiness, whether we are looking at a green field, brown field, sustaining operations, consideration must be given to the knowledge and skills of everyone involved.  This includes upper and middle management, front line supervisors, and technicians and operators.  As the organization grows, the focus on hiring is typically based on resumes.  When staffing, consideration must be given to the knowledge and skills of those individuals who will be managing and operating the company.  Resumes only give you a snapshot of the past.  With new people, processes and procedures, there needs to be a forward-looking approach to how everyone will be trained and qualified for their current and future roles in the company.  When people are hired and expected to perform based on resume experience alone, the picture that typically unfolds is the orange line depicted as “Not Operationally Ready” in our model.

This webinar will provide insight on what to consider when establishing training and qualification requirements for upper and middle management, front line supervisors, technicians and operators.

 

Top Ten Benefits

Upper and Middle Management

  • Designing for Operational Readiness
    • People
    • Program Development
    • Training Execution
  • Defining Upper and Middle Management
    • Roles and responsibilities
    • Knowledge and skills to consider
    • Resourcing (Internal vs. External)
  • Training and education
    • Soft skills vs technical skills
    • Experience
    • Previous experience vs required knowledge and skills

Front Line Supervisors

  • Definition of a Front Line Supervisor
    • Roles and responsibilities
    • Knowledge and skills to consider
  • Where Front Line Supervisors come from
  • Training and education
    • Soft skills vs technical skills
    • Experience
    • Previous experience vs required knowledge and skills
  • Operators and Technicians
    • Roles and responsibilities
    • Knowledge and skills to consider
  • Importance of the operator and technician role
  • Training and education
    • Soft skills vs technical skills
    • Experience
    • Previous experience vs required knowledge and skills

SPEAKERS


Jeff Hall

Associate Director, Human Performance, CAI


Jeff Hall is an Associate Director in Human Performance services with over 30 years of experience with implementing programs to support the start-up, operation, and maintenance of process systems and equipment. He has over 20 years of experience managing projects of up to $6M and leading groups of people ranging from one to over 25 persons. Jeff has an MBA and is an expert in Project Management. He uses the skills in these two areas to manage project costs and efficiency. He has used this approach to create focused, effective, and efficient organizations and successful project implementation. He is experienced in auditing, developing programs, and leading projects in GMP, GLP, and GCP environments.


Alice Redmond

Chief Strategy Officer, CAI


Alice Redmond, PhD is the Chief Strategy Officer at Commissioning Agents, Inc. She has more than 29 years’ experience in lifecycle management of pharma facilities inclusive of regulatory compliance, facility & process design, technology transfer, commissioning, qualification, and validation. Previously Ms. Redmond worked for Sandoz/Novartis in Basel, Kundl and Ireland in the areas of quality, validation and technical operations. Following Novartis, Alice led the Global Regulatory, Commissioning and Qualification Group for a Global Engineering Company for 13 years. Alice has large global project experience of green field facilities including fill finish, biotech, gene therapy, medical devices, small and large molecule API and OSD from design through to operational readiness. She is a former winner of the ISPE Robert F. Sherwood Article of the Year Award. She was a committee member on the Biotech and Disposables CoPs and Lead on the Knowledge Assets Committee. Alice currently serves on the ISPE C&Q CoP Steering Committee and is a former co-chair of this committee and the RQHC/RSC committees. She is on the ISPE Commissioning and Qualification Baseline® Guide Revision Team.