Highlands Information (Page 2)
Well - first of all - not every manager is a change agent. The skill set to "run the business" is vastly different from that needed to "change the business". As a matter of fact, skillful and experienced change agents are hard to find. Many steps required to improve the performance of an organization are actually counterintuitive, and only experience can lead companies successfully through these changes. The change process is also difficult because most of the participants cannot see the end state, and are therefore uncertain about different roles, behaviors, and evaluation criteria.
Change is also about disciplined setting of priorities - knowing what to focus on and what can or must wait. Too many change processes fail from over-ambition, or killing the seeds of change by changing too much simultaneously. There needs to be a logical and attainable progression, and the patience and courage to live with some sub-optimal processes while the most important wins are gained.
Finally, change happens ultimately on the shop floor, but begins at the top. Getting senior managers to develop and articulate a clear philosophy, which is detailed to guide decision-making within the organization, is a step that is frequently overlooked. Translating that philosophy into concrete ways of working - or "Rules" is the next step, before any procedures are changed. Even the process of senior managers getting together to discuss and agree on philosophy, and middle managers agreeing on rules are important steps to changing how an organization collectively thinks and acts.
At BAI, we can design together with you a vision of where your organization wants to go - your goal, and can help to plan, step by step, how to get there. We can lead your organization through the change process, help to avoid the pitfalls, and build confidence and credibility that fuels the process. We are the best change agents in the business, and our references speak for themselves.
cGMP/Regulatory Compliance and Quality Effectiveness Assessment and Remediation
For organizations that are planning to market products in the US and Europe, we can help in the regulatory compliance strategy preparation. We are highly effective in assessing manufacturing and testing sites for FDA compliance, and, unlike most corporate GMP auditors, we can quickly identify the "show stopper" issues and propose strategies for closingcompliance gaps in a pragmatic way that supports quality improvement within the business.FDA Inspection Preparation and Follow-up
Collectively, we have participated in, prepared for, and led more than 50 FDA
inspections. We've encountered a broad range of inspectors in a wide variety of
situations. We believe that having strong, effective, and transparent systems is
only a part of the equation when it comes to preparation for inspection -
getting people comfortable to present themselves credibly, and having an entire
manufacturing and quality team be able to seamlessly "sell" their organization
and operation is critical to success. - No "dog and pony shows" here, but just
thorough preparation under simulated "real life" inspection conditions - We can
offer strategies how to present critical issues, and can coach participants on
personal behaviors and effective communication.
BAI Partners have extensive experience in leading global system development, validation and deployment efforts. Some recent project examples include:
When does cGMP stop being added value and start
becoming added cost?
Aseptic/Sterile Processing Guidance
With our in-house microbiologist and aseptic processing expert, as well as several partners who have managed quality operations for sterile manufacturing sites world-wide, BAI is uniquely suited to help address a wide variety of issues regarding manufacture, validation, and control of sterile products manufacture. From review of sterile facilities design through design of environmental monitoring and media fill programs, failure investigation, GMP assessment, and equipment qualification and process validation expertise, BAI can fill you sterile processing support needs.Visual Inspection Programs and Parenteral Product Assessment
BAI can evaluate existing programs or develop new Visible Particulate Matter/Defect Inspection and Testing programs in parenteral facilities. Our specialty is to assist organizations new to visual inspection in fast tracking the basic inspection program development by providing essential background, training and guidance in a condensed time period. Our evaluations include reviewing/discussing/planning the following:
BAI has an experienced Microscopist on staff and can assist facilities with source determination of particulate matter problems or contamination events such as glass occurrences in finished product vials. Other focus areas where we can assist you in controlling particles are:
BAI Partners have extensive experience with all aspects of process and laboratory validation technology including computerized systems and CFR part 11 compliance. BAI will take a team approach in developing the appropriate documentation from Validation Plans and User Requirements to IQ, OQ, PQ protocols. We can also assist you with specialized validation requirements such as:
Laboratory Excellence Programs
BAI Partners lead Laboratory Excellence (LE) programs across small and large global organizations. Business benefits include: productivity gains of 20-60%, lead time reduction, Right First Time (RFT) quality improvements, compliance improvements and a more balanced and rewarding work environment for laboratory analyst. Laboratories that implement LE concepts yield trained individuals that become future leaders within organizations.
Laboratory Excellence modules include: mindset & behavior transformations, change management, lean concepts (leveling, flow, standard work, 5S), shift huddles, flexible workforce, reduced testing, method improvement, visual management, performance management and Gemba walks. Laboratory Excellence is further enhanced with paperless laboratory excellence modules including: Full paperless business and laboratory workflows, automation, instrument integration, enhanced analytical technology, e-visual management, QC testing at line and electronic performance management (KPIs).