Whether it is the kick-off meeting or a routine meeting, take time to develop and distribute an agenda. This single basic
tool will maximize the effectiveness of your meeting. Send the agenda out at least one full day in advance to allow all team
members to be as prepared as possible for a productive meeting. As important as agendas, meeting minutes are critical to the
documentation trail of the project. Use them to document decisions, discussions, and potential issues. Distribute the meeting
minutes to those who are not part of the actual team (affected departments and management). This allows everyone to have the
opportunity to keep in touch with the project's progress from their own desk.
Key points to remember
Define your corporation's terminology. Not all companies define a demonstration lot, a development lot, and a commissioning
lot in the same way. Do not assume that these definitions are industry standards.
Do not wait for the routine meetings to communicate with your peers on the other side. Email allows small details to be addressed
quickly. Establishing the parameters for an emergency or rush situation up front prevents false alarms throughout the process,
resulting in a relationship with a high level of trust. Crying wolf erodes trust. Both sides must be courteous in setting
realistic timelines for responses to questions, document reviews, approvals to procedures, and so forth. Moreover, communicate
when replies are required because it helps set priorities, and remember to set realistic goals.
Project leaders and team members must work together to maintain and control the project scope. With the project scope finalized
at the kick-off meeting and communicated in the project schedule, routine updates become critical in project management. The
timeline shouldn't be static—it is a living document that must be updated and published with meeting minutes. If a new task
is needed and inserted in the schedule, determine whether it is a clarification of a previous task or a new activity. If the
task alters the scope, let the business development department know.
Avoid unnecessary mid-course changes during the project. Surprises are inevitable, but consider carefully whether a significant
change mid-project is needed or whether other options exist. Change orders can be costly and threaten not only the project
schedule, but also your budget. Moreover, keep an eye on "walk-up" business. A simple request for another document or another
study may seem inconsequential, but over the course of the project, the extras actually take time away from the critical tasks.
Sometimes there is a business need for the add-ons, but there may be other options.
Minimizing scope creep is essential in project management. These changes drive up costs and lengthen the project schedule.
Although most scope-creep changes are small, added together they can endanger a project. A method to minimize or compensate
for scope creep is factoring contingency into the project schedule. Both the sponsor company and CMO have limited resources,
so the earlier something is known and communicated, the better. Modifications to the project schedule or a delay on an important
decision can't always be handled without adverse impact. Consider what happens if the project leader is out for a period of
time. What is the effect on the overall project timing? Who on the project team will step in and chair routine meetings? Who
will follow up on key decisions that must be made? Where are the data held, and can others access electronic files? Is there
a system in place to provide "human contingency planning"? Taking the time to plan for knowledge management is better than
insurance and costs less, too.
Finally, hold a wrap-up meeting to celebrate and review the project. Take time to learn from each project. Have both sides
evaluate not only their contributions but the other side's as well; communicate in an honest and direct manner. The goal is
to improve the system. Determine what was done well and what could have been done better. Don't let this become only a notetaking
session. Rather, use it as an opportunity to strengthen your project-management system.
Managing quality in contract manufacturing
Often the most challenging aspects of managing projects within the contract-manufacturing arena are those activities that
fall under the realm of the quality unit. These include quality assurance, quality control, and regulatory functions.