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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What Should be Included in a Calibration Program

One of the very important activities for a laboratory is calibration. The terminology found in 21CFR160 (b) (4) spells out the requirements for this aspect of medical devices. In addition, other terminologies and concepts that need to be applied for an effective calibration program, but are not found in the regulation, such as instrument classifications, also need to be taken into consideration.

Given this fact, it is important for professionals who work in laboratories to ensure that the laboratory has an instrument calibration program that assures that the instruments are calibrated at appropriate intervals using specific procedures that define the standards and tolerances that are relevant to and appropriate for the intended use of the instrument.

A well-structured learning session on calibration in the laboratory

All the core and supplementary aspects of laboratory calibration will be taught at a highly valuable learning session that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

At this webinar, Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. To gain complete understanding of all the important aspects of laboratory instrument qualification, please enroll for this webinar by visiting What Should be Included in a Calibration Program

Imparting understanding of the standards

The speaker at this webinar will show to participants how to apply measurement uncertainty or test accuracy ratio to specific calibration procedures, as well as the selection of standards needed to provide scientifically sound calibrations traceable to national references.

Building on the terminology found in 21CFR160 (b) (4); Jerry will base his teaching by relating and applying the concepts discussed to specific key instruments found in the testing laboratory. This learning will improve participants’ understanding of calibration and help them understand the ways by which to apply these concepts.

Jerry will cover the following areas at this session:

o  The regulatory and technical requirements for calibration.

o  What should be included in a calibration program

o  The importance of a data-based calibration interval and limits of accuracy and precision

o  The impact of measurement uncertainty when establishing limits of accuracy

o  The classification of test instruments

o  Current practices in the calibration of specific instruments

Laboratory Managers, Laboratory Supervisors, Laboratory Analysts that are responsible for the calibration of laboratory instruments, Laboratory Record Reviewers, Quality Assurance record reviewers and Quality Assurance Managers will gain important learning from this webinar.

How they take on water and therefore on how they react in the process

For any product that is being produced using the extrusion process; raw materials and their characteristics are the most important variable.

Grasp of why things happen as they do in the process and why the process and product being produced react as they do, can come about only when there is a basic understanding of the raw materials and how they flow, cook and potentially over-process.

Since different types of ingredients have different properties; each ingredient reacts very differently during the process and as the product’s defining characteristics are produced. For example, both starches and proteins undergo fundamental transformations during processing, but those transformations are very different from one another.

What complicates matters further is that most ingredients used in the process are a combination of the fundamental components (carbohydrates, protein, fat, etc.). So, all components are processing at the same time and undergoing a complex combination of transformations.

Insights into how raw material work in food extrusion

A fundamental understanding of the raw materials that are used, and their properties, is essential to knowing how to select raw materials during the product development phase as well as understanding how changes in raw materials are contributing to processing difficulties during production.

A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer understanding of these matters relating to raw materials for food extrusion processing.

Dr. Brad Strahm, who is a Principal with the XIM Group, LLC, a firm providing consulting services in the area of product development, process engineering, troubleshooting equipment engineering, and project management; will be the speaker at this webinar. to know more about this area from this expert, please register for this webinar by visiting Food Extrusion Processing

Discussion of raw materials used in extrusion

Dr. Strahm will offer fundamental food-science information about the raw materials that are typically used in the extrusion process of food products. The material covered will include information covering the structure, characteristics and cooking of carbohydrates, proteins, fats, and other additives important to the food extrusion cooking process.

Dr. Strahm will talk extensively about carbohydrates, which will include extensive information about starches – the most common component in extruded food products. Other aspects such as structure, cooking requirements, selection based on flavor, appearance and texture will also be explained. The speaker will also explain other carbohydrates such as fiber and sugar and their impact on the extrusion process and on developing the functional aspects of the extruded food product.

Proteins and fats

Proteins are also very important in extruded food products, even though they react very differently and their structure is very different from that of carbohydrates. Proteins play an important role in meat analog products as well as in protein enriched foods that are popular today.

The speaker will also talk about fats, which are also an important component in extruded products and have a large lubricating effect on the process. Fats also have an important energy-dense role to play in food products. The particle size of the raw materials plays an important role in how they take on water and therefore on how they react in the process. In this discussion, Dr. Strahm will talk about particle size as well as particle size distribution and its impact on efficiently producing quality product.

Many additives that are often used in extruded products that have a large impact on the process and on the product produced will be discussed. The speaker will share a few tricks of the trade for modifying cell structure and texture with the participants.

In this webinar, which will be of high value and usefulness to professionals associated with food processing and cooking, such as Product Developers, Production Managers, Production Operators, Quality Assurance Technicians, Purchasing Agents and Maintenance Personnel; Dr. Strahm will cover the following areas:

o  Carbohydrates: starch, fiber, sugars

o  Proteins: plant and animal sources

o  Fats

o  Additives

o  Importance of particle size.

15 ways to stay healthy in college

With crispy chicken strips and addictive fries at the Pilot House, nine seasons of The Office on Netflix and the newfound freedom of college, staying healthy and active at school can be more difficult than it was back home. Whether you’re a freshman or senior, it’s undeniable that healthy eating and self-care often takes the back burner when you have to juggle school, jobs and a social life.

Health-sayings-stay-happy-stay-healthy

Some freshmen even might worry about the “freshman 15,” a.k.a. the weight gain that can happen when freshmen come to college. Tanya Bachman, nutrition instructor in the School of Nursing, said weight gain and unhealthy eating habits are common in college.

“I think it’s very common, not every single person is going to experience it but it is common,” Bachman said. “It’s being away from home and learning how to feed yourself, at the same time balancing academic load.”

Whether or not you believe in the freshman 15, everyone can agree that staying healthy in college is hard — both mentally healthy and physically healthy. The Beacon put together a list of 15 ways to stay healthy this semester.

1. Watch what you’re eating

2. Don’t skip meals

3. Avoid unhealthy snacking

4. Avoid sugary coffee drinks

5. Stay hydrated

6. Take vitamins

7. Use the Beauchamp Center

8. Take a fitness class

9. Try yoga and meditation

10. Get active with your friends

For More to Continue click her http://snip.ly/iobd5

Who are involved in filing investigational new drug applications

Lack of data integrity or the presence of anomalies in data is one of the primary reasons for which the FDA hauls up and penalizes an organization engaged in pharmaceutical manufacturing. As the use of analytical methods for drug quantification at many stages of drug development process grows in prevalence; the need for scientists, technicians, and quality assurance personnel, etc. to understand the complete validation process of the analytical method has become all the more important and necessary.

The validation of a method used is all the more important when it comes to dealing with quantitative analysis of drugs in various biological matrices such as blood, serum, plasma, cerebrospinal fluid, urine, tissues, etc. Yet, many companies overlook these crucial aspects of validation that are outlined in FDA’s guidance, and end up receiving citations from this regulatory agency for these reasons. A company which receives these citations not only faces the prospect of delayed drug development; it can also dent and jeopardize the future of the drug’s regulatory acceptance.

Clear understanding of FDA guidelines for bioanalytical method development and validation

A complete and clear understanding of the FDA guidelines for bioanalytical method development and validation is necessary to avoid being in situations outlined here. It is to familiarize pharmaceutical professionals with this important aspect of the FDA guidelines for bioanalytical method development and validation that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar.

Venkata Kashyap Yellepeddi, who is an Assistant Professor of Pharmaceutical Sciences, College of Pharmacy, Roseman University of Health Sciences, Utah and Adjunct Assistant Professor, Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, University of Utah, Utah; will be the speaker at this webinar. Please register for this webinar by visiting FDA guidelines for Bioanalytical

This webinar will offer intensive and detailed understanding of the bioanalytical method development and validation for drugs and nutraceuticals outlined in the FDA’s guidance. This learning will add immense value to sponsors and analysts representing industries who are involved in filing any of the following:

o  Investigational new drug applications (INDs)

o  New drug applications (NDAs)

o  Abbreviated new drug applications (ANDAs)

o  Biologic license applications (BLAs)

o  Supplements in developing bioanalytical method validation information used in human clinical pharmacology

o  Bioavailability (BA)

o  Bioequivalence (BE) studies that require pharmacokinetic (PK) or biomarker concentration evaluation

Analysts involved in bioanalytical methods used for nonclinical pharmacology/toxicology studies and for the veterinary drug approval process will also find this webinar highly valuable.

Matching the FDA’s level of expectations

The FDA expects anyone involved in quantification of drug using an analytical method in any stage of the drug development to be well-versed with FDA’s guidance for bioanalytical method validation. With this assumption, FDA inspectors often ask questions on analytical method validation during routine inspections, and expect all personnel involved to be knowledgeable about the process of validation. This webinar will familiarize participants with these aspects of an FDA inspection.

Kash will cover the following specific areas during this webinar:

o  Chromatographic Methods

o  Ligand Binding Assays

o  Parameters involved in Bioanalytical Method Validation

o  Data Analysis, Statistics and Reporting

o  Additional issues in Bioanalytical Method Validation.

This course is of high value to those involved in one or another way with bioanalytical method development and validation, such as Chromatographers, Analysts, Chemists, Scientists, Formulators, Patent Lawyers, Technicians in Pharmaceutical and Veterinary Industry, and Contract Research Representatives.

Q7 and Other Requirements for Active Pharmaceutical Ingredient (ASM) GMP

In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; this guidance amends the International Council for Harmonization (ICH) codification from Q7A to Q7.

All aspects of API manufacture are addressed by this revised guidance. These include:

o  The principles set out for Quality Management

o  The quality unit’s responsibilities

o  Activities relating to production

o  Internal audits

o  Product quality reviews

o  Qualifications expected from personnel

o  Their hygiene standards

o  The qualification that consultants need to have.

The GMP requirements for facility design and construction and equipment used are also included in this FDA Q7 GMP guidance for API revision. Several other API manufacturing topics are also part of this revision. Some of these include:

o  Management of materials

o  Process controls

o  Laboratory controls

o  Packaging

o  Storage and distribution

o  Validation

o  Change Control.

Clarity on the FDA’s revised standard

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will explain the FDA’s API Quality System revision in detail.

Eyal Lerner, owner of ELC Consulting Services which offers the pharmaceutical and medical devices industries support in all quality related issues, will be the speaker at this webinar. To gain understanding of how to apply the FDA’s revised API Quality Systems GMP requirements; please register for this webinar by visiting API (ASM) GMP

Explanation of API quality requirements

This webinar will explain the basic requirements and fundamentals of API QS. It will review the quality requirements for API in accordance to global API GMP- ICH Q7. The explanations will be based on practical experience and other relevant guidelines. Eyal will review the requirements of FDA and EMA. All the areas such as materials, Active Pharmaceutical Ingredient and Advanced Starting Materials (ASM) will be discussed along with their definitions. He will also explain the distinctions between these.

Administrative issues such as registration issues concerning filling, annual review and change report to file would be discussed. In this section, Eyal will lay emphasis on the section: “Registration standard: Common Technical Document (CTD)”, as it relates to the ICH M4.

Anyone, whose work concerns the area of development and manufacture of API, such as those in R&D, Regulatory Affairs, Quality Assurance and Quality Control, who wish to get an in-depth background and understanding of API QS; will find this webinar valuable.