Telecoms World Africa is an established forum for the communications sector in Africa. The only one of its kind, this event provides a platform for top-level stakeholders to discover the opportunities for growth in Africa, and establish themselves as market leaders
This webinar will provide valuable assistance to all regulated companies that need to develop HACCP systems, including companies in the produce, meat, and processed food fields.
Description : Foodborne illness is often traced to improper cleaning and sanitizing of food equipment and the environment.
Operators of food facilities develop and implement Sanitation Standard Operating Systems to protect food from contamination. Specifics about the people, equipment, facility, cleaning and sanitizing methods and procedures must be carefully documented. Foodborne illness is often traced to improper cleaning and sanitizing of food equipment and the environment. Investigators point to failures of basic sanitation in recent nationwide outbreaks involving peanut butter, potpies and, spinach. Scientific systems such as Hazard Analysis Critical Control Point (HACCP) require the operator to control the potential for environmental contamination to avoid failure of the HACCP System.
Areas Covered in the seminar:
Development of Sanitation Standard Operating Procedures.
Master Cleaning Schedule.
Pre Operation Sanitation.
Operational Sanitation.
Verification and Logging Sanitation Procedures.
Validation of Cleaning and Sanitation.
Microbial Assessments of Food Environments.
Assignment and Management of Sanitation personnel.
Who will benefit: This webinar will provide valuable assistance to all regulated companies that need to develop HACCP systems, including companies in the produce, meat, and processed food fields. The employees who will benefit include:
Senior Management
Quality Assurance and Plant Management Personnel who oversee the daily cleaning and sanitation of the food processing environment
Third Parties developing HACCP plans
Auditors and those with food safety inspection roles
Optimising operations for continuous process improvements to enhance over-all efficiency and cost effectiveness of your laboratories
The
increasing importance of laboratories and its central role in decision
making
requires greater analytical precision, more stringent test selection,
and
interpretation of results. In order to minimise the frequency of
occurring
errors, better quality management will ensure recognised standard of
practice
and effective improvements in both productivity and cost.
Advanced
Laboratories
2010 will provide you with cutting-edge tools, trends and insights
in quality management and automation for improvement in turnaround time,
increased production and customer satisfaction. It will give you
practical
approaches to strengthen quality culture within the organisation, ensure
adequate expertise and knowledge with technical staff to readily embrace
opportunities for continual improvement while simultaneously reducing
costs and
successfully using new technologies.
Identifying the new types of fraud ,assessing the credit risk and developing strategies for revenue assurance
Operators need to be
aware that fraudulent activities can lead to increase churn as customers
seek
providers that can deliver a flawless service experience. Studies find
that
operators only recover one third of their total identified revenue
leakage and the
average of detected unbilled and under-billed revenue in this category
is
estimated to be almost one percent of the operator’s total revenue. Not
only
are Telcos experiencing challenges within
the market,
but also they are offering a wider variety of services and products in
order to
become more competitive and provide a better service for their
customers. These
developments present tempting opportunities for fraud which at the same
time
will lead to revenue leakage. In this regard they need to understand,
now more
than ever how to avoid fraud, data loss, security breaches and PBX
hacking.
The 4th
in our series of Telecoms Fraud, Risk and Revenue Management conferences
will
discuss the latest operator and service provider initiatives to combat
Fraud
and prevent to incidence of revenue haemorrhaging.We
will provide practical examples on what
problems the operators are facing and how to address it in order to
improve
their revenue management. Delegates attending this conference will
benefit from
discussions on the latest industry fraud prevention strategies and
develop new
risk management, fraud detection, monitoring and prevention solutions.
This session will provide an overview of the major tenants of
corporate board governance, structure, organization, and composition
and how each of these relates to an enterprise`s ability to balance
risk and opportunities while acting in an ethical and prudential manner
which addresses all its stakeholders - investors, employees, customers,
suppliers, creditors, regulators, and taxpayers.
Why Should You Attend: The popular perceptions of corporate governance have changed significantly since the global financial crisis.
- Prior to the crisis, during a period of expansion and growth,
investors and media had little reason to question corporate governance
at the board of director level or rising executive compensation
packages.
- The crisis changed perceptions dramatically. Corporate boards were
widely blamed for lax oversight, granting overly generous pay packages,
and generally for failing to perform in a prudential manner.
- Corporate governance has a direct & significant impact on
enterprise risk management, and there are proven approaches to
corporate governance that improve risk management
In this presentation we will explore the requirements for
post-design risk management and determine how to apply the
requirements. The presentation is conceived as a practical
demonstration of how to meet post-design requirements of ISO 14971. We
will review the production and post-production requirements of ISO
14971 as stated in Clause 9 and interpret their meaning for the medical
device industry. The presentation will use practical examples of the
application and use of risk management information as well as determine
when risk management files need to be updated. We will also review the
requirements for Management Review of risk management activities in the
post-design portion of the product lifecycle, and present examples of
how to meet these requirements.
Why Should You Attend: Medical device companies
have done some form of design risk management for many years, although
with the introduction of ISO 14971, the techniques have evolved and
improved. The area of Post-design Risk Management is new to the medical
device world with the introduction of ISO 14971. Companies are
attempting to interpret and apply these new requirements with mixed
results. In addition are the changing requirements of regulatory
bodies in the postmarket phase of the device lifecycle.
Foodborne illness is often traced to improper cleaning and
sanitizing of food equipment and the environment. Operators of food
facilities develop and implement Sanitation Standard Operating Systems
to protect food from contamination. Specifics about the people,
equipment, facility, cleaning and sanitizing methods and procedures
must be carefully documented. Foodborne illness is often traced to
improper cleaning and sanitizing of food equipment and the environment.
Investigators point to failures of basic sanitation in recent
nationwide outbreaks involving peanut butter, potpies and, spinach.
Scientific systems such as Hazard Analysis Critical Control Point
(HACCP) require the operator to control the potential for environmental
contamination to avoid failure of the HACCP System.
Areas Covered in the Session:
Development of Sanitation Standard Operating Procedures.
Master Cleaning Schedule.
Pre Operation Sanitation.
Operational Sanitation.
Verification and Logging Sanitation Procedures.
Validation of Cleaning and Sanitation.
Microbial Assessments of Food Environments.
Assignment and Management of Sanitation personnel.
This webinar will examine the stated intent of the Agency to get
tougher across the board in its expectations for the medical industry
and its compliance to the cGMPs, especially CAPA. It will examine how
these goals of the Agency have translated into action in the past half
year, with trends evident in 483 observations and Warning Letters. A
key to effective relations with the FDA is the emphasis on proving a
company is "in control" to an investigator`s satisfaction, which has to
center on CAPA. So the webinar will address the development of a new,
or revision of an existing CAPA SOP to ensure it meets those goals.
Why should you attend: The U.S. FDA has recently
declared a goal of "getting tough on CGMP compliance / enforcement",
together with mandating better science as a foundation. They`ve
supported this with increased hiring of investigators. Since CAPA
failings are a major problem in compliance, and is a key to voluntary
and meaningful compliance, this is one of the areas to come under this
increased FDA scruinty. Recent high profile negative publicity on
pharmaceuticals, devices, as well as events in unrelated industries
have put pressure on the Agency to be more aggressive, and should be a
wakeup call to industry to improve their CAPA systems, and then
promptly respond to what CAPA "tells" them. Contrary to regulated
industry`s perceptions, the public often sees this industry in a bad
light, and .wants change. Congress is starting to listen.
Laboratories that work in a GMP environment are required to have
documentation to show they are qualified to run specific, consistent
and reliable analytical test methods. Method qualification of a method
can be achieved in three ways: Validation, Verification (Compendial
Methods) and Method Transfer (company methods). Lack of such
documentation can result in warning letters from both the FDA and
Health Canada. This webinar explains the reason and purpose of USP
chapter<1226> and helps you to interpret what is required for
verification of pharmacopeia methods to satisfy regulatory
requirements. It discusses how to select appropriate analytical
performance characteristics and acceptance criteria and summarizes
documentation requirements of the verification process. The
verification process is clarified with a step by step guide with
reference to a USP monograph for an API.
Why should you attend: Are you confused with the
terminology used for method qualification
(verification/transfer/validation)? Have you received a 483 for not
adequately qualifying a compendial method or are you at risk to receive
one? Are you interested in knowing more about method verification? If
you answered yes to any of the above questions or would simply like
confirmation of your current approach to analytical method
verification, then this webinar is for you.
Areas Covered in the Session:
Introduction to USP Chapter <1226> Verification of Compendial Procedures
Why verification can be more difficult than method transfer
Determining appropriate analytical performance characteristics and setting realistic acceptance criteria
Protocol and report
Follow along with an example using a USP monograph.
This change control webinar will discuss the change control activities and documentation required to meet GMP requirements.
This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated change control activities and documentation requirements, especially in light of the changes in the FDA`s stance vis a vis industry compliance and past problems. It will help attendees understand and recognize the most common change control failings and their fixes, and assist in defining and recognizing changes.
Areas Covered in the Seminar:
Defining a "change" and "change control".
Tougher FDA Expectations / Requirements.
Areas impacted.
FDA "Hot Buttons".
Design Control.
Document Control; Archiving.
Identifying "changes".
Preventing negative changes and entropy.
Maintain a ‘state of control’.
Who Will Benefit:
This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical and Biologics fields. The employees who will benefit include:
Senior management
Regulatory affairs
Quality Assurance / QAE
Production
Engineering, R&D, and software development and testing teams
Important
Due to possible changes in conference details, we recommend that you check with the conference
website, before making any traveling arrangements.
* Prices are for evaluation only. For accurate prices, please check with conference website.
