What do Your Customers Really Think About Your Complaint Handling?

How companies in these industries should set up their complaint handling systems.

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Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing a webinar on the topic, “Complaint Handling” on February 6. Peggy J. Berry, President & CEO at Synergy Consulting, will be the speaker at this webinar.

Please visit http://bit.ly/2GFGiXr to enroll for this webinar.

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A complaint says a lot about a product. It helps the manufacturer to reflect on where it could have gone wrong. A complaint handling system is the antidote to complaints. A proper complaint handling system gives the manufacturer a proper idea of how its products are perceived in the market and how well it can respond to consumer requests. In areas such as medical devices and pharmaceuticals among others, the FDA has set out its requirements on how companies in these industries should set up their complaint handling systems.

GMP requirements have been set out for internal complaint handling for the GMP-governed areas. At this webinar, the speaker, Peggy Berry, will address approaches to setting up an internal complaint handling system that ensures compliance with all GMP requirements. She will address the various aspects of the review process, SOP preparation, investigation documentation, and the crucial aspect of how to respond to complainants. She will offer insights into what do your customers really think about your complaint handling.

Participants of this webinar will be able to set up effective internal systems to receive, investigate and respond to product complaints during both the investigational and commercial stages. Peggy will review of GMP requirements for complaint handling and explain the types of complaints that an organization may expect to receive.

She will show how to track the complaint from the time it is received and how to initiate and perform a complaint investigation. She will also show how to review the complaint and investigation and how to prepare a response to the complainant, as well as how to prepare an associated SOP.

This crucial webinar on putting in place an effective internal complaint handling system that ensures compliance with GMP requirements is of value to professionals in the areas of Manufacturing, Clinical Operations, Quality Control, Quality Assurance and Regulatory Affairs.

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About the speaker:

Peggy J. Berry is the President & CEO at Synergy Consulting, where she provides consulting services to companies in all aspects of drug development. She is the editor of the 2010 book, “Choosing the Right Regulatory Career” and author of the 2011 book, “Communication & Negotiation”. She consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society.

GMP Environmental Control for Pharmaceutical Clean Rooms

The subject of clean room contamination due to personnel is discussed.

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective

It is important that a clean room’s HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product.

This webinar first details and explains the various US and international regulatory requirements for various clean room classifications. Next, the webinar provides a comprehensive overview of the mechanics of clean room HVAC. This includes engineering diagrams and schematics. HVAC equipment components are detailed as well as the automated control systems that are available. Clean room design considerations are included. Proper building construction and layout is necessary to achieve both optimum efficiency of the system and optimum cleaning and sanitization of the clean room.

The principles of HEPA filtration are described along with desired clean room airflow patterns and how to achieve them. Proper procedures for HEPA filter leak testing is included. The webinar then provides valuable information on differential pressure, air velocity , flow rates, and air pressure balancing. Temperature and relative humidity controls and specifications are also detailed.

Comprehensive procedures for cleaning and sanitization of the clean room environment are presented along with a review of the best disinfectants currently available along with their respective advantages and disadvantages. The subject of clean room contamination due to personnel is discussed. This includes both gowning technique and aseptic practices.

Finally, a full set of requirements for HVAC system validation is detailed. Ongoing monitoring of the clean room environment is discussed with respect to schedule, specifications and OOS (out-of-spec) actions that may be required.

  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering
  • Maintenance

Personnel Gowning and Aseptic Practices in Clean Room

This Article Will Make Your Environmental Compliance Amazing: Read or Miss Out!

Both EPA and OSHA have tons of information about every aspect of environmental compliance. They are handy and easy to understand.

Environmental compliance is a critical requirement for workplaces in many parts of the world. In the US, this aspect of compliance is undertaken by the Environmental Protection Agency (EPA) in conjunction with the Occupational Safety and Health Administration (OSHA). These agencies coordinate with each other to ensure that environmental hazards are kept within specified limits so that they don’t affect the workforce or cause damage to the environment beyond prescribed norms or levels.

An example of the way by which these two agencies coordinate is the one that relates to the control of accidental release of chemicals from designated workplaces that may have an adverse impact on employees, the environment or the general public. While OSHA is given the responsibility of ensuring that chemical releases do not affect workers in the workplace under Sec. 304; Sec. 112 (R) of the EPA’s Clean Air Act describes how to protect the general public from the effects of such hazards.

In areas such as chemical accident prevention, the EPA and OSHA work closely in a number of designated areas, which include:

  • Helping companies that come under their regulatory guidelines to ensure compliance
  • Guiding and interpreting the regulations
  • Coordinating in strategies and actions relating to enforcement and compliance
  • Putting in place and implementing mechanisms for sharing information.

The fact that two federal agencies work in tandem to ensure environmental compliance makes this a serious issue that companies can ignore only at their own peril. The understanding of facts such as this goes a long way in ensuring environmental compliance because it drives home the criticality of ensuring environmental compliance.

Simple, yet effective tips for ensuring environmental compliance

This article will make your environmental compliance amazing: it offers simple, down-to-earth tips on how to ensure environmental compliance rather than drilling down complex and incomprehensible insights. These are some of the steps you could take to ensure environmental compliance:

Be in touch with the government agencies

This is the most obvious, yet the most effective way of ensuring environmental compliance. It is the governmental agencies that are responsible for ensuring compliance. So, who could be a better guide to help you with yours? Directly interacting with agencies such as EPA and OSHA will help you take the proper steps right in consultation with them. Also, make ample and maximum use of the resources that are available all over the Net. Both EPA and OSHA have tons of information about every aspect of environmental compliance. They are handy and easy to understand.

Take expert help

Experts are what they are: very knowledgeable professionals in their field. Taking the help of an environmental compliance expert will help you stay clear of the provisions relating to environmental compliance. Selecting the appropriate one in this connected world should never be an issue.

Implement compliance software

Many software applications that not only guide you in compliance but also carry out most of the requirements are available in the market. This type of software application is very helpful in taking the pain and the guesswork out of environmental compliance implementation. Agreed, the cost of buying, installing and running these software applications can be expensive. Yet, this cost neutralizes over the long run. More importantly, this cost is very small in relation to the cost of noncompliance.

Train your employees

No understanding of the regulations or implementation of any other tip is of any value unless the employees become an active part and stakeholders in ensuring compliance with the environmental regulations. Employees are the central players in environmental compliance. It is primarily for them that all the regulations are made. These are the core stakeholders in ensuring environmental compliance. The key is to make understand the benefits they get by implementing and complying with the environmental guidelines. This is when they can become active players in the entire endeavor.

4 Important CLSI Guidelines According to Assay Validation

They will use real life examples to demonstrate how to overcome some of the practical challenges when guidelines can not be exactly follow.

Each of the assay performance characteristics (specificity, sensitivity, accuracy, precision, linearity, stability, reportable range, reference range) will be explained in terms of experimental design and statistical analysis.

Most assay validations are a compromise between scientific principles, regulatory requirements, and limited resources in reality. They will use real life examples to demonstrate how to overcome some of the practical challenges when guidelines can not be exactly follow.

Though the CLSI guidelines provide much more actionable details than other guidelines (e.g. by FDA, USP), the understanding and adoption of the guidelines remains a challenge for the broad users. Plus, due to reality restraints, oftentimes the study design and/or the statistical analysis suggested by the guideline cannot be exactly followed.

In this webinar, major CLSI EP guidelines will be introduced. The focuses are

(1) interpreting the procedure for each guideline,

(2) intuitive explanation of the statistical methodologies,

(3) using real-life examples to illustrate the use of the guidelines, and

(4) discussing some solutions when facing challenges in implementing the guidelines.

CLSI

These are the areas covered by the mentor

 

  • Sensitivity (EP17)
  • Accuracy (EP9)
  • Precision (EP5)
  • Specificity (EP7)
  • Matrix effect (EP14)
  • Statistical Process Control (SPC)

Don’ Miss these Guidelines Going Viral

 

Too Busy? Try These Tips to (Streamline) Your Supply Chain Finance

Finance is the lifeblood of any business. Its role in a business with various interconnected loops such as supply chain is all the more prominent.

Too busy worrying? Trying these tips to streamline your supply chain finance could go a long way in helping you improve your bottom line. One of the very critical, yet often overlooked components of the supply chain is finance. Finance is the lifeblood of any business. Its role in a business with various interconnected loops such as supply chain is all the more prominent.

Supply chain rests on free movement of goods. It is built like a relay race in which goods are transported from one point to another. The essence of running a well-coordinated supply chain machinery is keeping the different connecting points well-oiled. One of the best mediums that facilitate this is finance. Why? Quite naturally, because when the different points of the supply chain are properly financed, the goods don’t get held up at any point. This is a point that a recent Ernst & Young study entitled, “Partnering for Performance — the CFO and the Supply Chain” brings about strikingly. It notes that there is an inseparable bond between well financed supply chains and higher earnings for organizations.

As important as the technologies

This points to the paramountcy of finance to the supply chain. The supply chain may have used the best technologies to put the most efficient tracking systems in place. It may have every bit of information to keep the supply chain up and running. But finance is the real essence of the operation. If for reasons related to finance there is some disruption in a part the chain, it affects the whole system adversely, carrying with it the potential to bring the entire chain to a halt.

Too busy? Try these tips to streamline your supply chain finance

By its very nature, supply chain is prone to a lot of volatility. It runs on coordination of many factors and between several players in the link. One loose link can destabilize the entire system. Let us say a shipment reaches a link in the supply chain. When there is a change in the requirement, requiring the content in the supply to be changed, it leads to delays in delivery. Till that time, the supplier has to bear the cost of the transportation, which leads to severe denting of margins, since the costs will go up.

Been too busy? You could try these tips to streamline your supply chain finance: The solution to this problem is financing the entire supply chain through means that are more or less favorable to everyone concerned. If all the parts of the supply chain are well financed, they will be able to absorb the shocks of such supply chain problems without having to sacrifice their business. This calls for financing at all levels of the supply chain. This is a very sound protection for all the uncertainties of goods and payments.

How is this to be done? That brings us to the next vital step in streamlining the supply chain finance: the use of technologies. Technologies such as supply chain management systems help companies to have complete visibility and control of the entire supply chain. This will help them understand just where the goods are stuck and the exact shortfall in finance that brought this about. When these systems are built on the cloud, they can become more versatile and cost-effective. Companies can also deploy the cloud for Business Analytics, which will throw up exact figures and insights pertaining to these aspects. A historical overview will help them which part of the supply chain to finance and how quickly.

Use of blockchain can ease the supply chain finance

Further, blockchain can go a long way in ensuring the transparency of the transaction at every stage. Blockchain, as we all know, is a highly decentralized online ledger system which will allow every transaction to be tracked and also made immutable with the record of the details of the transaction at every phase. Using this will help supply chain finance to be in perfect order and rid companies of all the confusion accompanying some kinds of transactions. They can always go back to the transaction to check its history and veracity.

https://www.infor.com/content/whitepapers/mastering-supply-chain-finance.pdf/?noRedirect=1

http://www.apics.org/apics-for-individuals/apics-magazine-home/magazine-detail-page/2017/07/13/the-supply-chain–finance-connection

Don’t Neglect to read in this busy life https://goo.gl/oKBs4t

Using autoantibody [biomarkers] to drive safer and more effective treatments

The game-changing importance of cancer immunotherapies and the coming of age of this approach was further confirmed by the awarding of the 2018 Nobel Prize in Physiology and Medicine.

For a number of years now, immunotherapy has been seen as the dawn of a new era, and is the most promising approach to cancer treatment since the use of targeted therapies, making headlines as results for successive novel immunotherapeutic drugs and combination therapies are released.

These innovative therapeutic strategies, which harness the body’s own immune response to fight cancer, have truly revolutionized the field, giving hope to the millions of individuals diagnosed with cancer every year.The game-changing importance of cancer immunotherapies and the coming of age of this approach was further confirmed by the awarding of the 2018 Nobel Prize in Physiology and Medicine to James Allison and Tasuku Honjo, for their remarkable contributions to the field ofimmuno-oncology.

Given their enormous potential, a broad range of immunotherapeutic strategies, including chimeric antigen receptor T-cell therapies (CAR-T cells), therapeutic vaccines and immune checkpoint inhibitors (CIs) are already on the market and numerous others are under active clinical development. Concerted research efforts have translated into large numbers of clinical trials, with various reports putting the number of ongoing trials at between 800 and 1000in the United States of America alone.Some of these treatments have already gained market approval, with a raft of new immunotherapeutic drugs expected to reach the market in the next couple of years.

This comes amid annual growth in the immuno-oncology sector of around 15% a year, according to Zion Market Research, with the market expected to be worth over 97 billion US dollars by 2022.

Despite this justified optimism, there remain a number of key challenges limiting the future potential of immuno-oncology treatments. While immunotherapies are proving to be highly effective in some groups, it is now clear that many patients do not respond to treatment or suffer from inflammatory side effects known as immune-related adverse events (irAEs). IrAEs can range from non-life-threatening conditions such as skin rash, through to more severe, life-threatening ones involving the endocrine glands, joints, liver, lungs and other organs, resulting in the potential termination of treatment. In some cases, fatal irAEs have been reported. However, as few standardized diagnostic criteria for irAEs currently exist, concerns have been raised that the number of incidences are underestimated.

Such irAEs are most prominent for CIs,owing to their mechanism of action and their widespread use in mono-, put particularly combination therapies.Immune checkpoints act as negative immune regulators of autoreactive Tcells – in essence, acting as ‘brakes’ – that preventautoimmunity. However, once these checkpoints are inhibited and these brakes are removed, the activated T cells can cause an over stimulation of the immune system,resulting not only in beneficial anti-cancer effects but also in an autoimmune response.

Because of these risks, irAEs have been known to put a stop to the clinical development of some immunotherapeutic drugs, they may also limit the progress of immuno-therapies in earlier stage cancer patients. Once severe irAEs are encountered, patients often decide (or are required) to discontinue their clinical trial participation or treatment. In some cases, regulatory bodies such as the US Food and Drug Administration have intervened to halt trials, even when promising results were observed. Clearly, this is a challenge for patients, bio pharmaceutical companies and regulatory authorities, and a solution is highly sought-after.

Audit Trail Generation and Review 2019

How to handle systems without automated audit trails, in a compliant manner.

Audit trails and describe the benefits of audit trail for your company. Attendees will learn the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

How to review audit trails, using a risk based approach to cull through the thousands of audit trail records that can be generated on a daily basis.

 

  • What is an Audit Trail
  • 21 CFR 11 / Annex 11 requirements for Audit Trails
  • Why Audit Trails
  • What are Audit Trail Features
  • What are Audit Trail Contents
  • What records need to have an Audit Trail
  • When does Audit Trail begin
  • What clock should be used for the timestamp
  • How is Audit Trail versioned
  • How is Audit Trail stored
  • What if my system does not have automated Audit Trail
  • What about “hybrid” systems

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital.

How to handle systems without automated audit trails https://goo.gl/gTa8He