Learn How to Prevent Quality and Compliance Problems by having a strong system for Purchasing Controls!

In this era of globalization; outsourcing has become a major component of business. Outsourcing brings many benefits for companies. Short and long-term cost benefits, the ability to concentrate on their core activities and grow their business, and the freedom of avoiding the actual tasks that go into manufacturing are some of the stated benefits of outsourcing.

When it comes to high precision, high technology and critical products such as medical devices, outsourcing brings many benefits, but comes with enormous challenges. Because of the nature of the products, and the intended use they are put to; medical devices need proper controls when they are being entrusted to suppliers. Controls are a dire need for any product, but more so for such lifesaving products as medical devices.

Disastrous consequences of lack of proper controls

Failed products or components can have disastrous consequences on the patients, who are the end-users of these medical devices. Avoiding such situations is in the interest of everyone concerned, be it the patient or the manufacturer. While the adverse effects of the use of defective medical devices on the patients are known; medical device manufacturers too, stand to suffer when such products enter the market. They suffer a loss of reputation. Their products could get recalled, and the FDA could slap 483’s or Warning Letters, or impose other harsh penalties on them.

Most important of all, the FDA holds the manufacturer and not the supplier responsible for any such mishap. Therefore, the need for putting supplier controls in place is critical. They must comply with the standards and requirements for this aspect set out by the FDA, namely CFR 820.50.

If manufacturers choose to manufacture their products themselves, the onus is equally high, because in this instance, they must put the right purchasing controls in place. Purchase starts with the selection of the raw material for the product and could potentially include the purchase of all components, each of which should comply with the standards specified by the FDA.

A complete understanding on how to put effective purchasing/supplier controls in place

A detailed learning session which will offer proper understanding of the controls that need to be put in place for purchasing/supply of medical devices is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, and who brings an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities; will be the speaker at this webinar.

Please visit 483 and Warning Letter citations to enroll for this webinar and gain complete understanding of the controls that need to be put in place for purchasing/supplier of medical devices.

Susanne will give the participants of this webinar an understanding of their responsibilities in terms of purchasing controls, which will enable them to provide safe and effective products to your customers. She will show how to prevent quality and compliance problems by putting a strong system in place for purchasing controls.

She will familiarize participants with the regulations and how they can translate these into an efficient and effective process for purchasing/ supplier control. The essential elements of purchasing control and how these can be translated into their procedures will explained. Susanne will also discuss the process steps for purchasing control and how it relates to other parts of a manufacturer’s QMS including receiving and acceptance activities.

She will cover the following areas at this webinar:

  • Understanding the regulations
  • Lessons Learned
  • FDA Expectations
  • Purchasing Controls Process
  • Planning
  • Evaluation of Suppliers
  • Purchasing Data
  • Performance Management
  • Feedback and Communication
  • Best Practices
  • Inspection Readiness

This session will help personnel in the medical devices industry who are connected with supplier and purchase, such as Supplier Engineers, Supplier Auditors, Supplier/Purchasing Managers, Quality Engineers, Supplier Quality Engineers, Compliance Personnel, and Compliance Specialists.

For more updates just click the below link controls for medical devices

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Who Benefits from the changes, and How it will affect the Retailers and Customers

Credit card surcharge was the bone of contention in an antitrust lawsuit filed 2005. As a result, the judgment in this case, which came in mid-2012, prohibited credit card surcharge in ten States. The implementation of their respective laws is underway in another 12 States.

Credit card regulations have traditionally opposed surcharging. Yet, companies have been devising ways by which they have sidestepped merchant rules and have continued to ensure that credit card surcharge gets levied. A kind of cat and mouse game is currently being witnessed, with State laws continuing to override networks merchant rules and companies looking out for ways to skirt the laws.

The issue of credit card surcharging in the US

The reason for which credit card surcharge is an issue for businesses is that it is the last link in the payment chain. A business that makes use of this facility incurs this expense at the rate set out by the authorities. It can be understood as a checkout fee that gets added to every consumer’s shopping bill whenever a credit card is used to make payments for the purchases made at the business. Businesses are not willing to bear this expense, and naturally, like to pass it on to the consumer.

What the court judgment of 2012 did was to permit charging of credit card surcharge for certain card transactions from January 2013. This judgment brought about a change in not only merchant processing transactions but also of credit card usage. The settlement it directed makes it mandatory for businesses that levy the credit card surcharge to follow requirements relating to consumer disclosure and to set limits on the amounts for which the surcharge is collected.

In addition, those businesses that accept credit cards to receive payments should also notify Visa and their acquirer of their decision to charge credit card surcharge a month before they begin to levy the surcharge. These rules vary from State to State, and the business is free to choose the brands of its outlet for which it wants to keep the credit card surcharge.

Total clarity on the issue

Sorting out the various confusions and misunderstandings pertaining to the credit card surcharge issue is the purpose of a webinar that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing. The speaker at this session, Ray Graber, a highly experienced professional in the payment industry, who brings deep and profound understanding of the way banking and finance converge with technology, will clarify the issues relating to this topic at this webinar.

In order to have your issues relating to credit card surcharging cleared, please visit payment methods like checks and cash to register for this webinar.

Clarity on all aspects of credit card surcharging

The aim of this webinar is to clear the muddle that has resulted from the changes in the rules. The speaker will explain who benefits from the changes, and how these changes are going to affect the retailers and customers. The adverse consequences of an uninformed reaction to surcharging by end-user organizations will be explained. Ray will emphasize the importance of first looking at the big picture of credit card surcharging, as end-users should also educate suppliers about the economics of card acceptance, explaining to them the savings possible and other benefits.

Business logic dictates that suppliers should not be adding a surcharge when they are reaping the rewards. Ray will explain how they might overlook the benefits of card acceptance, as well as the cost of other payment methods like checks and cash.

At this webinar, Ray will cover the following areas:

o  What changed in the rules?

o  Why did it change?

o  What rules apply to surcharge?

o  Survey results

o  Who may benefit?

o  Will this change anything?

o  Summary.

This learning session will offer benefit to every level of employee who works in the credit card industry, such as financial officers, small business owners, corporate risk officers, internal auditors, operational risk managers, credit card program administrators, CPA’s and attorneys and legal staff.

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The fourth season of Gurgaon’s biggest & most popular food awards concludes with fervour

Some of the biggest names of India’s hospitality industry descended at the Hyatt Regency Hotel Gurgaon on Wednesday evening to celebrate the fourth season of ‘The Big F Awards’ – undoubtedly, Gurgaon’s biggest & most popular food awards.

The gala event was marked with the presence of bigwigs from the food & beverage business including celebrity chefs and prominent food critics. Trust me, the list was endless with names like chefs Manish Mehrotra, Manjit Gill, Amrita Raichand, Manisha Bhasin, Rakesh Sethi, Saransh Goila, and Saby Gorai; food historian and critic Osama Jalali; author and columnist Anoothi Vishal; well known food critic Rinku Madan; and stalwarts of the culinary world including Zorawar Kalra, Rocky Singh, Ashish Singh, and Siddharth Talwar among others.

Last but not the least, Padma Shri awardee Chef Sanjeev Kapoor also graced the occasion with his presence. Chef Sanjeev Kapoor, who was the guest of honour at the event, just managed to make it towards the fag end of the awards as Mumbai has been facing incessant rains affecting all outbound flights from the city. However, even forces of nature were unable to stop Chef Sanjeev Kapoor from marking his presence at the awards underlining his commitment towards the whole concept of The Big F Awards – the biggest community driven food awards.

Pawan Soni, the brain behind The Big F Awards, played the perfect host by welcoming each guest with zeal and gusto. Pawan Soni is the founder-member and CEO of Indian Food Freak – a blog which he started to acknowledge the art of cooking and fine dining.

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FDA Warns on Mixing Opioid Addiction Treatments, Other Meds

TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity.

The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution.

The agency said a growing number of people fighting opioid addiction with methadone or buprenorphine also take other prescription drugs that slow action of the central nervous system. The warning lists several dozen brand-name and generic drugs that could be risky, including Ambien and Lunesta for insomnia, Valium and Xanax for anxiety, muscle relaxers Soma and Zanaflex and antipsychotic drugs Abilify, Invega, Saphris and others.

The agency stressed that treating opioid addiction with medication can outweigh those risks and is crucial to curbing the U.S. opioid epidemic, along with counseling, rehabilitation and other support.

“Careful management of the patient and coordination of care is recommended,” rather than denying use of methadone or buprenorphine, FDA Commissioner Scott Gottlieb wrote in a statement issued with the warning.

The FDA recommends that doctors develop detailed treatment plans, warn patients on addiction treatments about the dangers of taking multiple drugs that depress brain activity, try tapering them off those other drugs and monitor them with blood and urine testing.

Buprenorphine and methadone work by binding to the same brain areas as opioids, reducing cravings and withdrawal without producing a high. The FDA is requiring makers of those two medications to update their package inserts with information about the risks of using them with other drugs.

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What is the legal language of the FDA form 1572 or Device equivalent?

Form FDA 1572 is one of the primary documents needed when carrying out a clinical trial. Also called the Statement of Investigator; Form FDA 1572, called just 1572 informally, is a contract between the Principal Investigator (PI) and the FDA. This form contains all details of the subjects, as well as commitments from the PI.

It is a contract in which the Principal Investigator, the person who is in charge of the clinical trial, gives an undertaking to the FDA giving it the assurance that she will comply with all the requirements set out by the regulatory agency with regard to the trial.

By signing the FDA form 1572, which relates to IND studies, or the “Statement of the Investigator, which is meant for IDE studies; the PI is submitting herself to all the appropriate regulations, as this is a legally binding document by which they commit themselves to follow all of these.

The 1572 is meant to serve two important purposes:

It is a way of helping the FDA, as well as the sponsor of the study to qualify the PI, i.e., it gives the FDA and the sponsor of the study the opportunity to understand the Principal Investigator’s qualifications and ability to carry out the research in terms with the purposes it seeks to fulfil. It is also a way to verify that the site at which the clinical study is being carried out is appropriate for the study.

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The Form FDA 1572 also has another important purpose to fulfil.  It takes an undertaking from the Principal Investigator that the requirements set out by the FDA will be met during the trial. Failure to adhere to these commitments is considered a criminal offence, as something amounting to making false statements, and is liable for legal action under the terms set out in 18 USC 1001. This form has to be submitted whenever the sponsor selects the Principal Investigator to take charge of a clinical trial that is being conducted as an investigational new drug (IND) meets the criteria set out in 21 CFR 312.53 (c).

Other documents

Further, other documents such as 21 CFR 312.50, which deals with the General Responsibilities of Investigators, 21 CFR 812.100, which deals with the Responsibilities of Investigators for Biologics, and 21 CFR 812.110, which deals with the Responsibilities of Investigators for devices, need to be adhered to.

All these documents set out the general and specific responsibilities that the Investigators have when conducting a clinical trial. These start from who can qualify to be considered a PI to what qualification criteria sub investigators and research staff need to have.

A proper understanding of Form FDA 1572

FDA Form 1572 is thus an extremely important document that needs to be complied with fully if the clinical trial has to be considered compliant with the regulatory requirements. A full understanding of all the aspects that go into this will be spelt out at a webinar that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.

This webinar educates participants about the due diligence that investigators and their staff about their regulatory and legal responsibilities. Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena, will be the speaker at this webinar. In order to gain complete knowledge of this valuable guidance document, please enroll for this webinar by visiting signs the FDA form 1572

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There are nine statements in the FDA form 1572. Seven out of these begin with “I agree”. These are the important elements named in the 1572:

  • 21 CFR 50 (Protection of Human Subjects)
  • 21 CFR 56 (Institutional Review Boards)
  • 21 CFR 312 (Investigational New Drug Application/IND)
  • For Device studies, 21 CFR 812 (Investigational Device Exemptions/IDE) is added in place of 21 CFR 312.

The GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811 outline additional responsibilities. It makes sense for PI and sponsors to comply with the principles of Good Clinical Practices (GCP), and to also use their common sense.

Charles will give a proper understanding of all these at this webinar. He will cover the following areas at this webinar:

  • The Investigators role in the clinical research process
  • The difference between AEs and SAEs and the reporting requirements of the investigator
  • Why the investigator maintains a list of staff signatures?
  • Why the investigator files the signed and dated protocol?
  • Why the investigator is responsible for the IC process?
  • What is the legal language of the FDA form 1572 or Device equivalent?
  • Why is Financial Disclosure information important?

What is the history of the drug / device regulations?

Techniques to Follow Which Increase the Confidence in the Audit

Auditing is a very important aspect of quality in all the areas of the medical sciences. An audit is the most reliable and foolproof method for evaluating the extent to which the various activities in an organization comply with the requirements and expectations the principal has from those to whom various processes are outsourced. Audits are the main tools for a quality unit to monitor and ensure that those activities are performed in compliance with the manufacturer commitments for quality and regulations.

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An audit is also essential to ensure that the organization meets guidelines set out by the regulatory authorities. Its uses are more pronounced in areas such as medical devices, clinical research, pharmaceuticals, and other areas of the life sciences which require adherence to very accurate and rigorous standards of processes, procedures, quality and policies.

Further, audits are also conducted to assess the quality of material supplied by vendors, who could be from fields as varied as accounting to software to claims settlements to medical products. In this era of outsourcing, it is but natural to expect players in the healthcare industry to outsource several of their activities for a number of reasons.

An audit is extremely crucial in all these activities in the life sciences industry, because it helps to control quality and save costs and many troubles that could come up if the processes are not adhered to. Outsourcing only saves the manufacturer or the provider the trouble of having to do many activities by himself; it does not absolve him of the legal responsibility. The law is very clear on this: Whenever there is noncompliance with the regulatory guidelines; it is the principal, or the provider, on whose shoulders the blame squarely lies.

An audit is effective, but only if done rightly

It is for this critical reason for which audits have to be performed, both internally and externally. But then, an audit can fail too, if it is not done properly. In the field of medical sciences, there are well-established good practices and best practices in many areas, such as Good Manufacturing Practices, Good Laboratory Practices, and so on, but there is no such convention as a Good Auditing Practice. This makes the voluntary inculcation of best practices an imperative for professionals in the areas of medical auditing.

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This is of extreme importance considering that most areas of the medical sciences deal with human lives. A high value is attached to audit practices, as an error from any of them, such as Contract Manufacturing Organizations (CMO’s), subcontractors, and suppliers of many items can have very bad consequences.

 

A learning session on auditing of CMO’s

The concept of Good Auditing Practices may not have evolved yet, but guidelines, techniques, and practices are in place to ensure that the audit meets its requirements and fulfils its objectives relating to quality.

Want to explore the matters that go into making medical audits successful and how to audit CMO’s to ensure that the products and processes required in a number of areas of the life sciences comply with the regulatory guidelines? Then, a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will help you do this.

This webinar will have Eyal Learner, who is owner of ELC Consulting Services, which offers the pharmaceutical and medical devices industries support in all quality related issues, as the speaker. To gain insights into how to carry out audits and ensure an effective means of evaluating compliance with the objectives of the Quality System,  especially when it concerns suppliers and outsourcing operations like CMO’s, service providers, sub-contractors and raw materials suppliers; please register for this webinar by logging on to 3rd Party and Subcontractors

Helping auditing serve its purpose

At this webinar, Eyal will explain the vital purposes of auditing and the ways of ensuring compliance with the quality and regulatory standards set out by the regulatory agencies using the right auditing techniques. He will show practical aspects of auditing. Although auditing is based on set principles and is a well-planned activity; auditors have to contend with changes that keep coming up abruptly, unannounced.

Auditors need to be prepared for handling such situations, which is what Eyal will help understand. He will explain the audit techniques and skills needed in situations like this and show ways by which to make the audit to be successful and efficient. This course is particularly aimed at auditors, potential auditors and auditees working for the pharmaceuticals, medical devices, and API and Excipients industries.

Eyal will cover the following areas at this webinar:

  • Short regulatory overview on external audits
    • GMP Requirements
    • Types of Audits
    • Rights & Duties
  • Planning
  • Off-site Assessment
  • Prefaces to Audit Techniques
  • General Techniques
  • Specific Techniques
  • FDA’s Quality System Inspection Technique (QSIT)

CAPA and Follow-up.

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.

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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.

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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.

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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.