Relationship Between an EM Excursion Program and CAPA

The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom environmental monitoring are stringent and scientific. The FDA proceeds on the thinking that nil contamination of not only cleanrooms, but all locations involved in aseptic processing is not possible.

Picture1

Based on this thinking, the FDA has formulated its guidelines on cleanroom EM taking into consideration the limitations of obtaining completely microorganism-free environment for cleanrooms. It seeks to bring about a consistent EM system that meets high environmental quality requirements all the time, being able to detect changes and deviations in this consistency level and bring the level to control limits.

Regulations that cover all areas of cleanroom environmental monitoring

Keeping this in mind, the FDA has formulated regulations that cover all aspects of cleanroom environmental monitoring, starting from the buildings and facilities, right up to the qualification and training required for personnel manning these cleanroom facilities to what should go into closures to validation of the aseptic processing and sterilization techniques. These cGMP regulations are found in 21 CFR Parts 210 and 211.

All the disciplines of cleanroom monitoring, such as quality, manufacturing, engineering, quality, environmental monitoring, sterilization and cleaning and many others need to be taken into full consideration while building an FDA-compliant monitoring program. These should be included all along, into all these phases:

  • Planning phase
  • Design phase
  • Construction phase
  • Commissioning phase
  • Qualification phase
  • Submission phase
  • Operational phase

A complete understanding of the FDA’s regulations

The ways of understanding and implementing the FDA’s regulations for environmental monitoring program will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Cleanroom 2356496

The speaker at this webinar is Joy McElroy, who in over the 20 years of total experience she has had in the pharmaceutical and biotech industries has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous companies.

Want to learn the ways of understanding FDA regulations for environmental monitoring? Then, please register for this webinar by visiting

Ways of ensuring compliance

Joy will highlight the importance of compliance with the FDA regulations on environmental monitoring, as the costs of noncompliance are much more exorbitant than those of compliance. Participants who take part in this training will be able to get a proper grasp of how to implement a cleanroom Environmental Monitoring (EM) program that complies with the FDA’s regulations.

She will describe the basis of the four phases of cleanroom transitional monitoring (Pre-qualification through post-qualification EM) and explain what each type stands for. In addition to describing what has to be the basic content of a well-designed, effective and compliant EM Program; Joy will also go on to help participants comprehend the relationship between an EM Excursion Program and CAPA.

Testing 845196515689516

This training session is of high value to Quality Control, Quality Assurance, Microbiologist, Facilities, Chemist, Analysts, Manufacturing, Validation, Engineering, Sterility Assurance, Compliance, Testing Technicians, Environmental Testing Personnel, Raw Materials Manufacturers, Clinical, Research and Development, and Laboratories.

Joy will cover the following areas at this webinar:

  • Applicable Regulations – Where does the EM Program fit in the Regulation? – Role of Clean room Environmental Monitoring Program?
  • Basics of Setting a Robust and Effective EM Program – Key Considerations – Relevant Material Verification Processes – Steps and Content of an EM Program Testing Procedure
  • Processing a Completed Environmental Monitoring Test Media – Sample Handling and Incubation – Documentation and Data Management of EM Test Results – What is the EM Test Data used for? – Retention of EM Test Results – Interpretation of EM Test Results
  • Basics of Designing an Effective and Compliant EM Trend Reports – Types; Content – Using Trend Report as a Critical Tool and Quality Metrics
  • Basics of Designing an Effective and Compliant EM Excursion Program – Types; Content – Handling EM Excursion Investigation – Handling Impacted Manufactured Batches – Disposition of Affected Products with Failed Clean room EM Test Results
  • Corrective and Preventative Action (CAPA) – Relationship between CAPA and EM Test Data Excursion Investigations Question and Answer Session.

Understanding the way the FDA works in handling food imports

The FDA’s task is cut out when it comes to one of its core functions –that of regulating imports. With the US economy absorbing food imports to the tune of $ 49 billion every year and with its allied regulatory agencies overseeing an astronomical number of nearly half a million facilities in the US and abroad; the FDA is certainly in a most unenviable position.

food-imports-and-exports-1

In view of the fact that these foods are imported from almost all over the world to be sold into the US market; the FDA has strict regulations for ensuring the quality of the food items that enter the US market. Its primary task is to ensure that the foods and food products that enter the US market met the rigorous standards it sets in relation to safety, sanitation, wholesomeness and labeling.

Coordination with agencies across the country

Considering this fact, plus the fact that over two thirds of seafood and more than a third of all the food items consumed in the US are imported; it is no surprise that the FDA has a varied number of agencies with which it coordinates and whose help it takes to carry out its functions. These are some of them:

  • Homeland Security                              12662901_f520
  • Customs and Border Protection
  • The FDA and the USDA
  • Center for Disease Control
  • Food Safety Inspection Service
  • Agricultural and Marketing Services
  • Food and Nutrition Services
  • The U.S. Department of Commerce
  • Department of Defense, and
  • The Federal Trade Commission (FTC).

In-depth understanding of the FDA’s work on food imports

Want to explore how to understand these agencies work in tandem with the FDA and want to ensure that your products reach US shores without hassles and get regulatory approval from the FDA? Then, you need to attend a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

The speaker at this webinar is John Ryan, who began Ryan Systems a decade ago and who has been involved in the manufacturing, food, transportation and Internet industries over the past 30 years. To enroll for this webinar and gain the immensely sharp insights John brings into the FDA’s thinking on food imports, please visit

http://www.compliance4all.com/control/w_product/~product_id=501359LIVE?Wordpress-SEO

Complete understanding of the FDA’s work on food imports

John will offer understanding of the ways in which the various agencies work with the FDA in respect to food imports. A deep understanding in this area is necessary for those who want to import food to the US and gain regulatory approval for their products, since they all work with the FDA at various levels.

He will cover the following areas at this session:

  • Global Food Markets drive new import food safety requirements
  • Review how the FDA’s Food Safety and Modernization Act (FSMA) are changing things
  • Understand “Prior Notice” requirements
  • Foreign Supplier Verification Program (FSVP)
  • Prepare for the Foreign Facility Inspection Program
  • Learn what is in the “Investigations Operation Manual” (IOM)
  • What can happen to your product when seized
  • Learn what other countries require for food import
  • Review the proposed rules for food safety and quality during transportation processes
  • Learn how much food and what food is imported from different countries
  • Understand what the Imported Seafood Safety Program includes
  • PREDICT & OASIS Systems
  • Other resources available to help you.

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.

Read more

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.