How the supposed microbial control or monitoring approach SHOULD be handled.

That water systems are critical to the pharmaceutical industry is a given. This fact makes it absolutely imperative for pharmaceutical companies to get a grasp of the techniques needed for getting these systems right. Product recall, costly downtime and many other related negatives are some of the consequences of not getting these matters right.

Among the primary causes, on account of which pharmaceutical companies get their water systems wrong, is the number of water system biofilm control and microbial monitoring myths that dominate the industry. Pharmaceutical water systems experts are often in awe of the level to which myths have permeated the industry, to the extent that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are simply completely wrong. They are often bemused at how traditions that could be so totally wrong are so strongly rooted, misguiding practitioners in the industry.

Understand water system biofilm control and microbial monitoring myths and know how to defeat them

Busting these often dangerous water system biofilm control and microbial monitoring myths is the core of a webinar on pharmaceutical water systems that is being organized by Compliance4All, a highly popular provider of professional trainings for all the areas of regulatory compliance.

At this webinar, the world-renowned expert on pharmaceutical systems, Dr. Teri C. Soli, will be the speaker. Dr. Soli, who is Principal Consultant at Soli Pharma Solutions, will take participants through all the myths that have been prevalent in the water systems industry for so long.

In order to understand the nature of water system biofilm control and microbial monitoring myths and subsequently get your pharmaceutical water systems right, just register for this webinar by visiting

http://www.compliance4all.com/control/w_product/~product_id=501243LIVE?Wordpress-SEO

Destroying water system biofilm control and microbial monitoring myths one by one

As a first step to shattering water system biofilm control and microbial monitoring myths, Dr. Soli will zoom in on the many reasons that have resulted in the perpetuation of these myths. But whatever the cause, one needs to be aware of the myths and understand how to do away with these.

He will lay threadbare each of the common water system biofilm control and microbial monitoring myths that are doing the rounds in the pharmaceutical water systems industry. He will be discussing the water system biofilm control and microbial monitoring myths that are related to microbial control approaches as well as microbial monitoring.

He will take up each myth, trace and explain its origin, and then put how the supposed microbial control or monitoring approach should be handled into true context, rather than how it is being handled.

In this session on water system biofilm control and microbial monitoring myths, Dr. Soli will cover the following areas:

  • Why water myths develop
  • Impact of c-GMPs
  • Well-meaning but misguided precedents
  • Scientifically unchallenged traditions and benchmarking
  • Rule-hungry culture
  • Water System Microbial Control Myths
  • WFI from RO
  • Turbulent Flow and Flow Rate
  • Dead Leg Rules
  • Smooth Surfaces
  • In-Line Sterilizing Filters
  • Ozone
  • Microbial Enumeration Myths
  • Referee Methods
  • Thermophiles in Hot Systems
  • R2A, 35°C, 5 days
  • Test Filter Membrane Rating
  • Compendial Action Levels
  • TOC and Endotoxin as Microbial Count Correlates.

Emerging Issues in Food Safety-Globally

The Global Food Safety Initiative is a private enterprise by those in the food industry aimed at offering guidance to the food industry for making food chain safer. This industry-driven initiative seeks to provide thought leadership on the various aspects of food and guides the food industry on implementing safety standards along all the points in the food chain.

Origins of the Global Food Safety Initiative:

The Global Food Safety Initiative was conceived and finessed in the 1990’s and 2000’s in the backdrop of various international food-related crises such as the mad cow disease in the UK, the dioxin affair in Belgium and the 2008 listeriosis outbreak caused by the Canadian company Maple Leaf. These crises triggered a strong desire for collective action by the food industry for taking creative preventive steps that could stall the occurrence of such events in the future. These crises provided the reason for the birth of the Global Food Safety Initiative.

The Global Food Safety Initiative was born out of the realization by leaders in the food supply and retail industries of the lack of coordinated audit procedures in the industry. Whatever audit and other checks and balances methods existed till then were largely fragmented, which is why they believed these crises happened. One of the primary aims of the Global Food Safety Initiative was to coalesce these procedures and set standards for their implementation.

The Global Food Safety Initiative, which was created out of collaborative actions from an independent network, the Consumer Goods Forum (CGF), which consisted of CEO’s from the leading players of the food retail industry, has a vision of making safe food available to consumers, no matter where they are located.

Objectives of the Global Food Safety Initiative:

The core objectives of the Global Food Safety Initiative are:

The workings of the Global Food Safety Initiative:

The Global Food Safety Initiative carries out its aims and objectives by holding meetings, conferences and seminars and other such events at local and regional levels. The aim of the Global Food Safety Initiative is to use these events as the platform for sharing knowledge of how to go about their work. The Directors of the Global Food Safety Initiative are chosen from among the leaders of the industry. The CGF drives the day-to-day functions and administration of the Global Food Safety Initiative.

Certification from The Global Food Safety Initiative:

Depending on the stream of retail business a company is in, The Global Food Safety Initiative issues certificates to entities that satisfy its conditions on meeting safety standards. To get certified from the Global Food Safety Initiative, companies in the food retail industry need to meet required standards by having the necessary audits carried out for their systems. Once a Global Food Safety Initiative certificate is issued, the organization has to ensure its upkeep by carrying out regular subsequent actions as required.

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Controlling pests in food processing and foodservice

Food establishments continue to be a major source for pests due to the changes brought about in the means and ways by which food is produced and handled and in the ways of preparation techniques and eating habits. The pests in turn are sources for illness-causing microorganisms. The more knowledge about pest control at their disposal; the better it is for food processing and foodservice personnel, because this is essential for ensuring a safe food supply for consumers.

Pests such as cockroaches, houseflies, rats, mice, and birds are the main sources for foodborne illnesses. To bring about a clean and disease-free food supply chain, their entry and eradication from infiltration into food establishments has to be ensured. Tracking and preventing foodborne illness is among the first steps food establishments need to put in place to achieve this.

A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show the ways by which do to this. Norman Marriott, who is a senior Consultant in the food industry, will be the speaker at this webinar. Participants can gain the full benefit of the speaker’s rich experience by registering for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501024

This webinar is valuable for food processing and foodservice personnel such as Foodservice Managers, Food Processing Supervisors, Workers, Food Business Owners, and Food Safety Professionals in helping gain knowledge of ways by which to implement pest control measures and thus ensure sanitary conditions for food establishments.

Controlling pests is important and useful for food establishments

Effective pest control practices are essential for protecting consumers from unhealthy food that can cause foodborne illness and economic losses to the food industry. Thorough educational information about how sanitary conditions for food establishments can be improved enhances the foodservice organization’s reputation, protects against foodborne illness, and increases sales and net profits of food establishments. When this is achieved; employees’ performance goes up, and with it, their morale. Highly energized and motivated employees enhance and improve customer satisfaction.

Norman will cover the following areas at this webinar:

o  Sanitary facility design

o  Description of pests found in food establishments

o  Pest prevention techniques

o  Pest eradication techniques.

Getting a grasp of the FDA’s New Enforcement of 21 CFR Part 11

That the FDA has become more rigorous in the enforcement of Part 11 through its new Part 11 and on-going data integrity inspection and enforcement program is evident in this: In just the last three years, it issued more than 30 Warning Letters with Part 11 and data integrity violations. The most common citations are related to not only inadequate integrity, security and availability of electronic records, but also to validation of software and computer systems.

Among the most important questions about the program is what major findings inspectors are looking at. So, companies need to be even more vigilant then before in implementing their electronic records. In view of these developments, it is essential to have in place a proper and foolproof process for ensuring integrity, authenticity and availability of electronic records.

A learning session on understanding the matter

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will explain how to achieve all these. Dr. Ludwig Huber, Ph.D., who is Director of Labcompliance, will be the speaker at this session. To understand how to get a grasp of the FDA’s thinking on Part 11 enforcement, please register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501062

Practical lessons

Dr. Huber will use industry proven case studies on how to avoid 483 inspectional observations and Warning Letters. With this learning, participants will be able to learn how to prepare their organization for trouble-free Part 11 related inspections.

Dr. Huber will set out detailed, six-step plans for helping companies maintain these records. The learning at this webinar will also feature several other strategies and learning experiences to make sure that there will be no surprises should an FDA visit a participant’s company.

Dr. Huber will include three SOPs as an additional bonus to enable easy implementation for participants to this webinar. These are the ones:

o  Checklist: Part 11 compliance

o  Case Studies: How to avoid Part 11 related 483’s and Warning Letters

o  SOP: Electronic Audit trail: Specifications, Implementation, Validation

These are the areas this webinar will cover:

o  FDA’s current inspection and enforcement practices

o  FDA’s new interpretation: learning from FDA inspection reports

o  Strategy for cost-effective implementation of Part 11: A six step plan

o  Recommended changes to existing Part 11 programs to reduce costs

o  Justification and documentation for the FDA and your management

o  Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.

o  Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues.

o  How to prepare your company for Part 11 Inspections.

Putting in place food processes that facilitate traceability and recall

The Food Safety Modernization Act (FSMA) has strengthened the FDA’s enforcement authority. The FDA now has the authority to not only mandate product recalls; the records and information they may request to see have increased as well. What has also gone up is the FDA’s documentation review authority.

Allergen mislabeling microbiological and foreign material contamination are the leading causes of Class I recalls. Given this fact, the need is for developing quality systems that result in good traceability and lessen the impact of a market withdrawal or even recall. Food organizations need to put in place a thorough traceability system that starts with the management team and includes the operators.

Putting a comprehensive system in place

This system should be a comprehensive one that must comprise everything from lot identification throughout the supply chain, to effectively reviewed recovery exercises. The teams in charge of these systems must be ready to quickly execute the plan in the event of an incident.

All this should not only streamline the traceability of the product and its documentation aspects; it should facilitate the ease with which a product recall is monitored and followed up, which will help bring down the cost of communication, product return and disposal. This has become all the more important and necessary with the federal government expected to put in additional funding aimed at allowing even greater sampling and inspection of products and facilities from the start of 2017.

Reducing recovery time for customers

Given that brand confidence takes a hit every time an alert gets issued; not having a well-oiled traceability and recall mechanism could mean increasing the recovery time for customer sales following a product recall and eventually, losing the customer.

All the nuts and bolts of putting a highly effective traceability system will be the topic of a highly useful webinar that is being organized by Compliance4All, a very accomplished provider of professional trainings for all the areas of regulatory compliance.

John Ryan, a Ph.D. who has been involved in the quality profession on an international basis in a variety of industries Quality Systems spanning the manufacturing, food, transportation and Internet industries over the past 30 years, will be the speaker at this webinar. To enroll for this webinar, register by logging on to http://www.compliance4all.com/control/w_product/~product_id=500998

A comprehensive understanding of all the areas of traceability and recall

Traceability could consist of quite a variety of potential applications ranging from simple case level bar code systems to more sophisticated satellite systems that include sensors for explosives and bacteria. John will explain these, along with test data from a number of these systems that will be shown in cross country and trans-ocean applications. He will also explore other elements of traceability, such as farm, distribution center, blending operations, and pallet level vs. container and case level systems.

John will explain the requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls. All the associated important areas of information such as identification, classification and protocols, and the technologies that are used at various price levels for tracking and recall, will be covered.

More technological aspects, such as an integrated food safety system model that uses traceability, food safety and recall data to demonstrate how computer technology can be used to reduce the time to recall products and reduce the impact to human health, will be discussed. The model is based on the FDA FSMA concept for risk reduction and uses predictive modeling to point investigators in the right direction in the minimum time.

The following areas will be covered at this webinar:

o  Self-reporting, Trade and Consumer and Classes of Recalls

o  FSMA expanded authority to stop and seize

o  Product and Process Vicarious Liability

o  Traceability standards, controls and practices

o  Overlooked transportation issues

o  ISO 22005 traceability standards

o  Current trends and common issues

o  Lot Identification at the case, pallet and container levels

o  Recall Classifications.

Standardizing Transportation Procedures is Necessary to Control Food Safety and Quality

Building a standardized sanitary transportation system in compliance with the FSMA’s new Proposed Rules for the sanitary transportation of human and animal foods is included in the FDA’s FSMA hazard analysis risk-based preventive controls requirements for improved food safety during transportation processes. For this reason, food transporters need to have a clear understanding of these rules. The consequence of the inability to establish and keep required documentation is predictable: It makes food transporters liable to heavy fines and business closures.

This is why for any company that transports food or causes food to be transported, preventing food adulteration and preserving food quality by standardizing and controlling transportation processes is critical. Every company must have a consistent ability to meet customer and legal food safety transportation compliance requirements. Activities such as food container tracking, sanitation, temperature and humidity control and record keeping are becoming supply chain issues requiring increased scrutiny and attention across all company locations.

Learn how to do it

How a food transporting company can develop a general plan and procedures to standardize and control food quality and safety transportation processes so that it stays compliant with the regulations and escapes penalties will be the learning from a webinar that Compliance4All, a leading provider of professional trainings for all areas of regulatory compliance, will be organizing. At this webinar, the highly renowned Quality Systems professional, John Ryan, who has worked for over three decades in a variety of industries globally and owns Ryan Systems, will be the speaker. To derive the benefits of this highly educative course, just visit http://www.compliance4all.com/control/w_product/~product_id=500997 to register.

For food shippers, carriers and receivers, as well as for buyers, the journey in establishing the required supply chain controls begins with where to start and ends with meeting compliance requirements. In the end stage, compliance demonstrates and establishes a basis for meeting newly evolving requirements relating to FSMA food safety during transportation.

Standardization and measurement of processes

John will offer a clear understanding of how measurement of food transportation processes can provide important management information that helps control potential harm such as shelf life loss, food recalls, human illness and death. He will touch upon issues in food transportation like case, pallet and container technologies and system designs, and also explain Return on Investment (ROI) techniques along with actual data from a variety of shipments to show how a lack of management and control can cost more than the sanitation and traceability technologies would.

Another aspect of this course is that the speaker will review an understanding of suggested management, sanitation, temperature monitoring/traceability, hazard analysis, and training standards, which will help participants develop relatively simple procedures that are referred to in the shipper’s contract of carriage.

Attendees of this webinar will be able to:

o  Establish standardized company-wide food safety and quality in transportation

o  Gain a competitive advantage

o  Standardize processes across multiple plant locations

o  Reduce liability

o  Meet buyer and customer food transportation safety and quality requirements

o  Ensure retailers that transportation suppliers comply with food safety standards and quality and regulatory requirements

o  Lay out specific guidelines to impact basic business processes

o  Improve customer relationships

o  Meet FDA FSMA and international transportation food safety regulations

o  Satisfy food producer requirements for sanitation, temperature controls, and traceability

o  Increase exporting opportunities

o  Provide risk-based and preventive applications

o  Gain efficiencies through standardized solutions

Identifying and resolving common issues in FDA Software Validation & Verification

Verification and Validation (V & V) are two important aspects of regulatory compliance for software. What all are needed for achieving this? The FDA, GAMP and others provide guidance in the methodology and documentation needed for this. This apart; consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V.

The U.S. FDA has stated that software validation can only be risk-based. This applies to software: a) As-Product; b) In-Product, c) In Production and Test Equipment, and d)  The Quality System. This webinar will take a look at these.

 

A learning session to help understand the nitty-gritty of V & V

To offer complete understanding of the topic of V & V for medical device software, Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a webinar.

John E. Lincoln, a senior medical device and regulatory affairs consultant, will be the Speaker at this webinar. Just visit http://www.compliance4all.com/control/w_product/~product_id=500816LIVE/ to enroll for this highly educative session.

All areas of the use of FDA, GAMP, and other models

This webinar will address the use of the FDA, GAMP, and other applicable industry Software Validation, professional trainings, medical device software, organizing a webinar, software validation models. It will supplement these with the ISO 14971 model to structure, run, and document acceptable software validations.

It will cover these areas:

o  Verification or Validation –Current Regulatory Expectations

o  The Project Validation Plan

o  Product Software Validation and Process/Equipment Software Validations –how they differ

o  When and How to Use DQ, IQ, OQ and PQ

o  ISO 14971:2007 Issues

o  GAMP Guidance

o  The 11 Key Elements of the Software V&V Model

o  “White box” and “Black box” Validations

o  ‘Real World’ Considerations