System of performance appraisal having the following characteristics: (1) each manager is

required to take certain prescribed actions and to complete certain written documents; and (2)
the manager and subordinates discuss the subordinate's job description, agree to short-term
performance targets, discuss the progress made towards meeting these targets, and
periodically evaluate the performance and provide the feedback.

Management by Objectives (MBO) is a process of agreeing upon objectives within an

organization so that management and employees agree to the objectives and understand what
they are in the organization.

The term "management by objectives" was first popularized by Peter Drucker in his 1954 book
'The Practice of Management'.[1]

The essence of MBO is participative goal setting, choosing course of actions and decision
making. An important part of the MBO is the measurement and the comparison of the
employee’s actual performance with the standards set. Ideally, when employees themselves
have been involved with the goal setting and the choosing the course of action to be followed by
them, they are more likely to fulfill their responsibilities.

Unique features and advantage of the MBO process

The principle behind Management by Objectives (MBO) is to create empowered employees who
have clarity of the roles and responsibilities expected from them, understand their objectives to
be achieved and thus help in the achievement of organizational as well as personal goals.

Some of the important features and advantages of MBO are:

1. Motivation – Involving employees in the whole process of goal setting and increasing
employee empowerment increases employee job satisfaction and commitment.
2. Better communication and Coordination – Frequent reviews and interactions between
superiors and subordinates helps to maintain harmonious relationships within the
enterprise and also solve many problems faced during the period.
3. Clarity of goals

Organizational commitment

 
The most effective way to implement MBO is to allow the top-level managers to explain,
coordinate and guide the programme. Without top management support and commitment, MBO
cannot be implemented properly. MBO presents a challenging task to managers. They must feel
that the programme is important and will bring in results. The shift from planning for work to
planing for accomplishment of specific goals is not easy. As rightly pointed out by Hampton,
“More often than not, probably, MBO is tried and sooner or later allowed to slip into disuse.
Initial enthusiasm and good faith wane as difficulties develop”. Joint goal-setting, participation in
planning and decision-making processes, objective performance appraisal sessions pose
several problems to managers who are wedded to old ways of thinking and action. These
problems should not be allowed to kill MBO without ever being openly confronted. Managers
must believe that MBO would work and must accept it as a way of thinking. As Knootz pointed
out, it is essential that “an effective programme of managing by objective must be woven into an
entire pattern and style of managing. It cannot work as a separate technique standing alone”.
MBO should not be used as a decorative piece. If it does not have the active support,
involvement and commitment of top managers, it should not be installed at all.
 An organizational structure is a mainly hierarchical concept of subordination of entities that
collaborate and contribute to serve one common aim.

Organizations are a variant of clustered entities. An organization can be structured in many

different ways and styles, depending on their objectives and ambiance. [clarification needed] The
structure of an organization will determine the modes in which it operates and performs.

Organizational structure allows the expressed allocation of responsibilities for different functions
and processes to different entities such as the branch, department, workgroup and individual.
Individuals in an organizational structure are normally hired under time-limited work contracts or
work orders, or under permanent employment contracts or program orders.

Social organization of a group includes how people interact, the kinship systems they use,
marriage residency patterns, how they divide up the various tasks that need to be completed,
who has access to specific goods and knowledge, what ranking strategy is being used.

social organization

 the people in a society considered as a system organized by a characteristic pattern

of relationships; "the social organization of England and ...
wordnetweb.princeton.edu/perl/webwn
 Social organization or social institution, refers to a group of social positions,
connected by social relations, performing a social role. It can also be defined in a
narrower sense as any institution in a society that works to socialize the groups or
people in it. ...
en.wikipedia.org/wiki/Social_organization
 The ways in which a social unit is subdivided into smaller groups whose membership
is determined by kinship, age, location, gender and other criteria.
foragers.wikidot.com/glossary
 patterns of cultural behavior related to life events, such as birth, death, child rearing,
and health and illness, that are followed within a ...
wps.prenhall.com/chet_spector_cultural_6/10/2795/715705.cw/index.html
 An entity that carries out a wide range of voluntary cultural, educational and
recreational activities.
wps.pearsoned.co.uk/wps/media/objects/1065/1090612/glossary.html
 Tlingit society was hierarchical. Each clan had a nobility, made up of the headmen of
clans or lineages and their families. ...
www.encyclopedia.com/doc/1G2-2536601257.html

You need Legal Organization

Running your practice from home or office is not easy. Are you facing any of these challenges?

 Not enough time to properly file important documents.

 Papers laying in piles with no organized filing system.
 Unable to quickly and easily locate documents using current filing system.
 Spreadsheets and database information that is in need of updating.
 Unattended correspondence that is backlogged by months or even years.
 Mail that is unsorted and/or left unanswered.
 Background research that is needed but you have little or no time to commit to it.
 Reports that have yet to be written.
 With Legal Organization you will:

 Run a more efficient practice by being better organized.

 Feel secure in the knowledge that your support needs are being met by a competent
professional.

sole proprietorship

A business structure in which an individual and his/her company are considered a single entity
for tax and liability purposes. A sole proprietorship is a company which is not registered with the
state as a limited liability company or corporation. The owner does not pay income tax
separately for the company, but he/she reports business income or losses on his/her individual
income tax return. The owner is inseparable from the sole proprietorship, so he/she is liable for
any business debts. also called proprietorship.

A sole proprietorship, or simply proprietorship (British English: sole trade) is a type of business
entity which legally has no separate existence from its owner. Hence, the limitations of liability
enjoyed by a corporation and limited liability partnerships do not apply to sole proprietors. ...

sole proprietorship is an unincorporated business owned by a person.

A business structure in which an individual and his/her company are considered a single entity
for tax and liability purposes. A sole proprietorship is a company which is not registered with the
state as a limited liability company or corporation. The owner does not pay income tax
separately for the company, but he/she reports business income or losses on his/her individual
income tax return. The owner is inseparable from the sole proprietorship, so he/she is liable for
any business debts. also called proprietorship.

General Partnership

A business partnership featuring two or more partners in which each partner is liable for any
debts taken on by the business. Because the partners do not enjoy limited liability, all the
partners' assets can be involved in an insolvency case against the company.

A partnership is a type of business entity in which partners (owners) share with each other the
profits or losses of the business undertaking in which all have invested. ...

A public company or publicly traded company is a company that has permission to offer its
registered securities (stock, bonds, etc.) for sale to the general public, typically through a stock
exchange, or occasionally a company whose stock is traded over the counter (OTC) via market
makers who use non-exchange quotation services.

Securities of a public company

Usually, the securities of a publicly traded company are owned by many investors while the
shares of a privately held company are owned by relatively few shareholders. A company with
many shareholders is not necessarily a publicly traded company. In the United States, in some
instances, companies with over 500 shareholders may be required to report under the Securities
Exchange Act of 1934; companies that report under the 1934 Act are generally deemed public
companies. The first company to issue shares is thought to be the Dutch East India Company in
1601.

Advantages

It is able to raise funds and capital through the sale of its securities. This is the reason publicly
traded corporations are important: prior to their existence, it was very difficult to obtain large
amounts of capital for private enterprises.

In addition to being able to easily raise capital, publicly traded companies may issue their
securities as compensation for those that provide services to the company, such as their
directors, officers, and employees.

In comparison, privately held companies may also issue their securities as compensation for
services, but the recipients of those securities often have difficulty selling them on the open
market. Securities from a publicly traded company typically have an established fair market
value at any given time as determined by the price the security is sold for on the stock exchange
where the security is traded.

The financial media and city analysts will be able to access additional information about the
business.

Disadvantages

Privately held companies have several advantages over publicly traded companies. A privately
held company has no requirement to publicly disclose much, if any financial information; such
information could be useful to competitors. For example, publicly traded companies in the
United States are required by the SEC to submit an annual Form 10-K containing a
comprehensive detail of a company's performance. Privately held companies do not file form
10-Ks; they leak less information to competitors, and they tend to be under less pressure to
meet quarterly projections for sales and profits -- and thus may be better placed to make good
decisions for the long-run.

Publicly traded companies are also required to spend more for certified public accountants and
other bureaucratic paperwork required of all publicly traded companies under government
regulations. For example, the Sarbanes-Oxley Act in the United States does not apply to
privately held companies. The money and income of the owners remains relatively unknown by
the public.

Private Company

A limited liability company in the UK restricted to between 2 and 50 shareholders. The shares
cannot be transferred without the consent of other shareholders, and cannot be offered to the
general public.a

What are the advantages and disadvantages of the main types of organizational forms.
Advantages of Proprietorships Disadvantages
and Partnerships
1. Easy to form 1. Limited life
 2. Few regulations 2. Unlimited liability
3. No corporate income taxes 3. Hard to raise capital
4. Being one’s own boss

Advantages of Corporations Disadvantages

1. Unlimited life 1. Double taxation
2. Easy to transfer ownership 2. Costly set up
3. Limited liability 3. Costly period reports required
4. Easier to raise capital
Hybrid forms are successful because they can combine the advantages of several forms or
organization. For example, the limited liability partnership has the advantages of a partnership,
without the disadvantage of unlimited liability.

---------------------

RAW MATERIALS

Method Development and Validation

QCL offers analytical method development and validation services for Active Pharmaceutical
Ingredients (APIs), Drug Production Formulations, cleaning agents used in manufacturing
processes, and raw materials/excipients. The dedicated group of chemists that perform these
studies have many years of experience in such disciplines as HPLC,  GC, ICP, AA and
Dissolution. All method validations are performed under cGMP requirements and meet the
current ICH and FDA guidelines.

Raw Materials Analysis

QCL offers a 10-day turnaround time on all raw materials testing. This applies to USP, EP, JP,
BP, FCC, ACS, and client-supplied methods. For all compendial purified water testing, QCL
offers a 5-business day turnaround time. QCL's dedicated group of experienced chemists allows
us to offer this exceptional turnaround time. All documentation is extremely detailed, and fully
GMP reviewed at test completion. Because of the stringent checks and balances between the
laboratory and the Quality Assurance Group, all final results are guaranteed to be accurate and
reliable.

Stability Storage and Testing

QCL offers stability storage and testing as part of our stability management services for drugs
substances and drug products from development to market.  Our experienced team of chemists
allows us to offer development/validation of stability indicating methods, forced
degradation studies, impurity/degradant characterization, in addition to routine analytical
and microbiological testing.  QCL can completely manage your study from start to finish
beginning with protocol creation and management and ending with data evaluation including
stability summary tables (FDA format or custom), data trending, and expiration date
prediction.  With our recent expansion QCL has all of the typical ICH storage conditions
available (25°C/60%RH, 30°C/65%RH, 40°C/75%RH, 5°C, -20°C, Photostability (Option 2)). 
Ask about our other capabilities including: climatic zones III and IV storage, 25°C/40%RH for
semi-permeable containers, thermal cycling, and freeze/thaw studies.  All conditions are
continuously monitored by the Kaye Labwatch Facilities Monitoring and Alarm Notification
System and is equipped with a natural gas generator for power backup.

Trace-metals Analysis
QCL performs routine testing, as well as method development and validation, for the assay of
metallurgic impurities in raw materials and finished products. QCL has the capability to
simultaneously scan for trace levels of any metal contaminant. Some of the support
instrumentation includes ICP and AA (equipped for flame, cold vapor, and graphite furnace
technologies). The ICP has the capability to scan for up to 72 metals in less than three minutes.
The spectrometry group has extensive experience with all facets of ICP and AA analyses.

Microbiological Testing
QCL offers microbiological testing of raw materials, intermediates and finished products. The
testing applies to USP, EP, JP, BP, FCC and client supplied methods. The laboratory is
equipped with state of the art equipment such as a qualified autoclave, temperature mapped
incubators and HEPA supplied biological safety cabinets. Services offered are:

 Microbial Limits/Bioburden/Water Testing

 Endotoxin testing (LAL)
 Disinfectant Qualification
 Antimicrobial Preservative Effectiveness Testing
 Cleaning Validation Support
 Method Validation
Test method validation on raw materials, intermediates and final device

I was hoping for some advice concerning test method validation.

We undertake a series of QC tests (on raw materials, intermediates and final device) on a
product currently in development and I am struggling as to how I can validate a number of these
tests. Some are common such as pH, dimensions, FT-IR analysis whilst other are fairly product
specific.

My question relates to how to go about validating some of these test methods. How would you
validate a pH test. Do you approach it from a material/product point of view or the equipment
perspective (I know how to calibrate a pH meter/probe but is this sufficient?) Another thing I am
having difficulty with is how to validate the FT-IR analysis of a compound. In this instance
linearity isn't an issue.

Any advice with this would be appreciated.

Manufacturing Process Validation

As a global leader specializing in providing a full scope of validation services for computer
systems, facilities, and manufacturing processes and devices within pharmaceutical, medical
device, and biotechnology companies worldwide, Arbour Group L.L.C. understands the mission-
critical importance of having a fully qualified manufacturing environment.

Our validation professionals are thoroughly familiar with the current FDA requirements for
validation and have the technical expertise, the management foresight and the international
support systems to help our clients ensure that all elements of the manufacturing process are
validated in compliance with applicable regulations to minimize their business risk and to
enhance their ability to compete successfully in the marketplace.

Arbour Group's Manufacturing Process Validation Services involve a comprehensive and in

depth exploration and evaluation of every aspect of the manufacturing environment, including
but not limited to:
 Building Management Systems (BMS)
 Distributed Control Systems (DCS)
 Manufacturing Execution Systems (MES)
 Manufacturing Facilities
 Utilities and Related Services
 Equipment and Maintenance Cleaning
 PLCs
 SCADA Systems
 Manufacturing and Packaging Processes

Through the use of proven methodologies and time-tested validation tools, our exhaustive
examination and resulting recommendations focus on compliance with regulatory requirements
including cGMPs (21 CFR Part 211), Electronic Records and Signatures (21 CFR Part 11) and
Quality System Regulations (21 CFR Part 820) and effectively reduce validation time-to-benefit.
A value-added result of our Manufacturing Validation Process is to address issues of product
quality as they impact a client's potential for success in a highly competitive marketplace.
Arbour Group's Manufacturing Process Validation Services include the following deliverables:
 Validation Master Plan
 Validation Project Plan
 Validation SOPs
 Validation Protocols
 Validation Summary Reports and Recommendations

With extensive, hands-on process validation experience, Arbour Group's professionals have a
proven system in place to offer clients a turnkey approach to validating their manufacturing
processes. Our process validation services can be as expansive as the development and
implementation of a validation program for an entire manufacturing operation or as focused as a
specific project tailored to an individual facility, utility system, equipment, manufacturing
process, or software application. The bottom-line benefit of Arbour Group's Manufacturing
Process Validation Services translates to effective business risk management, enhanced
product quality and, ultimately, increased market share.

Validation Protocol
1. General information
2. Objective
3. Background/Prevalidation Activities
Summary of development and tech transfer (from R&D or another
site) activities to justify in-process testing and controls; any
previous validations.
4. List of equipment and their qualification status
5. Facilities qualification
6. Process flow chart
7. Manufacturing procedure narrative
8. List of critical processing parameters and critical excipients
9. Sampling, tests and specifications
10. Acceptance criteria
Reference to: Stability protocol/packages, protocol change provisions
(i.e., procedures to handle any deviations), plans for a biobatch comparison
(formula, process, specifications)

Note: Resolve deficiencies in any of the above prior to executing the protocol.

Validation Report
Executive Summary
Background
Presentation and Discussion of All Results.
- Statistical Summary of IPC data, Control charts
- Critical Processing parameters/operating ranges
- Evaluate data points outside of in-process limits
- Elegance evaluation
Deviations - impact assessment on validation
Conclusions
Recommendations, Attachments
Reviewed and approved by same colleagues that
approved the protocol.

PACKAGE VALIDATION

Package validation involves two separate validations: 1) the design validation of the package as
a component of the device and 2) the process validation of the packaging process. Design
validation uses evidence to establish what design specifications will conform with the user
needs and the intended use(s) [830.3(z)(2)]. Process validation establishes by objective
evidence that a process consistently produces a result or product that meets predetermined
specifications [820.3(z)(1)].

The regulation, of course, refers to establishing evidence that the manufacturing steps involved
in packaging the device will consistently produce packaging which meets specifications. For
example, the process capability of packaging and sealing equipment should be determined
during process validation and documented. Validation of the package design shall be performed
under actual or simulated use conditions that show the package conforms to its stated intended
uses. Risk analysis shall also be included where appropriate.

Design validation results shall include: the design identification, name of the individual(s)
performing the validation, method(s) used, and the date. All of this information should be
recorded in the design history file. If any significant change is made in the packaging or
packaging operation after validation, the new process will need to be revalidated.

One of the most difficult aspects of package validation is determining how many samples to test.
The goal is not to over test because of cost considerations while still running sufficient tests to
provide statistically valid sampling. Statistical methods of analysis are important in process
validation. The following decision tree from Medical Device and Diagnostic Industry,
"Streamlining Package-Seal Validation," October 1992, provides various methods of statistical
analysis. The manufacturer is challenged with determining which statistical method is most
applicable to their individual needs. See Chart 1 below for possible methods of analyzing data.
The resulting validation plan should identify, measure, and evaluate the key processes and
variables that will require assessment to complete a validation or revalidation of the packaging
and the packaging process.

PACKAGING PROCESS

The packaging operation is a manufacturing process as described in Section 820.70, Production

and Process Controls. Other GMP sections also apply to packaging including, but not limited to:

 Receiving, In-Process and Finished Device Acceptance, section 820.80; and

 Distribution, section 820.160.

These sections require adequate controls for components, processing, and test/inspection. The
controls necessary for all devices should assure that:

 labeling, whether a separate label or printed on the package, properly reflects the
package contents and other labeling requirements;
 the packaging materials meet the device master record specifications;
 only devices approved for release are packaged and released; and
 the packaging operations are performed according to established procedures.
The controls required will vary with the type of device packaged. For example, when a sterile
device is packaged, a manufacturer's considerations should include:

 environmental and personnel hygiene control;

 validated operating procedures for sealing equipment;
 inspection to assure package integrity and sanitation; and,
 stringent control of packaged devices marked "sterile" but not yet sterilized.

For a product to be sterilized in-house, either a physical quarantine area or label control should
be used to prevent shipment of devices marked sterile, but not yet sterilized. The required level
of control is very high. The stringent control also extends to give-away samples not intended for
actual use on patients -- samples should be sterile if so labeled because they might be used.
One approach is to sell samples at zero cost so that the samples are subjected to all of the
company finished product controls.

A written procedure is required by 801.150(e) for interstate contract sterilization. The purpose
of this requirement is to help prevent the erroneous release of packaged and labeled "sterile"
devices that are not yet sterilized even though they appear to be sterile and ready for release.
Regardless of whether 801.150(e) applies, the QS regulation requires sufficient controls as
necessary to prevent mixups in complex situations such as contract sterilization. For
consistency, a contract is commonly used by manufacturers for interstate and intrastate
shipments. Such a contract, and compliance with it, satisfies the applicable GMP requirements.

Section 820.181(d) requires that the device master record include packaging methods and
processes. Written instructions should be provided to assure that the necessary controls are
understood and consistently implemented. The need for, and the extent of, written instructions
should be determined based on the complexity of the operation and the nature of the product.
Some products such as radioimmunoassay test kits can deteriorate during packaging if the
process is not timed properly. In such cases, written instructions should describe how the
device(s) should be handled and expedited during packaging in order to prevent delays, and
thus deterioration.

The procedure for testing and/or inspection of finished packages shall be written [(820.80(d)]. To
the extent feasible, the testing of finished packages should be quantitative. The packaging of
sterile devices should be tested and/or inspected before and after sterilization. This testing is
done on a sampling basis. Sampling plans are valid only when a process is in a state-of-control;
therefore, the device must be manufactured and packaged using a quality system as described
in this manual.

Manpower Technical Services offers staffing solutions and employment opportunities in a

variety of technical and professional arenas. Our customers include the majority of Fortune 1000
companies in Eastern North Carolina, as well as many innovative and growing companies. This
diversity allows our employees exposure to many different industries.

Quality & Validation Professionals

Description:

You're precision-oriented, intuitive and a stickler for doing it right. You have a solid working
knowledge of biological research and scientific study. You're a critical thinker who is adept at
using logic and reasoning to identify the strengths and weaknesses of alternative solutions. You
understand the value of working as a team, yet you function strongly on your own. If this
describes you, you'll want to learn more about this opportunity from Manpower Professional.

We are seeking a Validation Professional, who In this position, will have the opportunity to:

 Review validation documentation for quality assurance.

 Provide quality engineering support to projects, facilities and subsidiaries.
 Perform formal supplier quality evaluations; conduct supplier and internal quality audits.
 Develop and adhere to Validation Plans, ensuring the on-time delivery of projects in
accordance with regulatory requirements.

Qualifications:

You are motivated. Driven. You get things done. You're passionate about research and are
highly analytical. If this describes you, you will want to learn more about this rewarding
opportunity.

Does your career expertise include?

 A BS degree in Life Science or Engineering field.

 3-5 years of experience with quality reviews of validation documentation and protocols.
 A working knowledge of FDA and GMP regulations and technical expertise with
automation, electrical, HVAC, QC and manufacturing within the pharmaceutical industry.
 Besides gaining valuable experience with some of the most reputable organizations in
the market, you'll gain access to Manpower Professional's comprehensive benefits
package. We offer all the advantages you would expect from an industry leader -
including a competitive salary, comprehensive health benefits, paid time off, training and
much more.

Computer System Validation

The critical nature of computer technology utilized in laboratory and manufacturing

environments requires a thorough evaluation of computer systems and programs to verify
compatibility with industry and regulatory expectations.

When implemented, a thorough computer validation program provides the necessary protocols,
certifications, testing and implementation of all the necessary development phases into a
comprehensive program.

VSI has experience including the validation of laboratory and manufacturing information
systems, automated manufacturing lines and facility supervisory control and monitoring
systems. VSI is available to provide the latest technical and regulatory consulting.
We offer complete services with the development of computer validation plans and gap analysis
to work with in-place programs. Product development details are assessed within this program
in accordance with a life-cycle approach. User requirements, system and functional
specifications are developed and incorporated into the necessary test scripts. A traceability
matrix is implemented to provide a complete approach to addressing all program requirements
from conceptual design to final product. Supplier audits, assistance in procedural development
or review for maintenance, operation, and configuration management of the system are also
performed to complement the computer validation program.