The vital area of Pharmaceutical Process Engineering

Pharmaceutical Process Engineering is an often-overlooked area in the field of pharmaceutical manufacturing. It calls for a high degree of precision and coordinates technical expertise and communication between professionals involved at diverse levels of the manufacturing unit, such as pharmaceutical researchers, chemical engineers and industrial. It is concerned with how pharmaceutical development is related to the application of major concepts and important unit operations in the field of pharmaceutical engineering.

Development and adaption of technology is one of the major bottlenecks of pharmaceutical process engineering. The major changes that digitization has brought into areas such as say, education and automobiles are yet to be fully realized in pharmaceutical process engineering. The benefits of digitization are yet to be felt and fully put into use in the crucial areas of pharmaceuticals, such as manufacturing -which, being a high precision area, offers tremendous scope for the use of conceptualizations such as the Internet of Things (IoT)- supply chain management, and Quality Control.

Lack of integration between the core functions and regulatory pressures are often cited as major reasons for which pharmaceutical process engineering is yet to catch up with the drastic changes wrought by technology.

Full understanding of the area of Pharmaceutical Process Engineering

A complete assessment of the present scenario in the pharmaceutical process engineering field, along with the its prospects for the future will be made at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. At this session, Co-founder and CEO of CGMP University Inc. Training and consulting organization and well-known author of several books relating to GMP; David Muchemu, will be the speaker.

Want to understand the importance and the prospects of this very vital area of pharmaceutical process engineering? Then, please register for this webinar by visiting Choosing process variables to control

Preventing flare-up of issues

David will help participants understand how to avoid being in situations where issues arise after scale up. The main reason this happens is that process variables and their parameters are never established based on hard data and engineering realities. David will offer a solution that combines engineering factors and scientific data collected in the lab into process control to counter such problems. He will explain the following major topics relating to these:

o  The process concept

o  Design of Experiment: DOE

o  Choosing process variables to control

o  Process validation

o  Process scale-up

o  Batch reactors

Of high value to professionals in pharmaceutical process engineering, such as Quality Engineers, Manufacturing Engineers and Line Managers; this webinar will cover the following areas:

o  Quality Risk Management Defined

o  Compliance Requirements for Quality Risk Management

o  The Quality Risk Management Model

o  Quality Risk Management Life Cycle.

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Current and future USFDA food import and export safety regulations

The US economy’s appetite for ingesting food imports is phenomenal, to use a mild term. How else does one describe an economy that takes in $49 billion a year? Considering that the FDA is the sole regulating agency that is tasked with overseeing imports of this magnitude, who can envy its responsibility? This is not all that the FDA does: its allied regulatory agencies monitor about half a million facilities in the US and abroad.

Since foods from almost every country in the world are brought in into the US to be sold in this huge market; the FDA has put in place very strict regulations for ensuring the food items that enter the US market are of set quality standards. To do so, it sets stringent standards that relate to the critical attributes of food, such as safety, sanitation, healthfulness and labeling.

The FDA coordinates with agencies across the country

The FDA’s coordination with other agencies is gargantuan, given the fact that about seven-tenths of seafood and 35% of all the food items consumed in the US are imported. It works with a number of agencies to carry out its functions. These are some of the agencies with which the FDA works in close association:

o  Homeland Security

o  Customs and Border Protection

o  The FDA and the USDA

o  Center for Disease Control

o  Food Safety Inspection Service

o  Agricultural and Marketing Services

o  Food and Nutrition Services

o  The U.S. Department of Commerce

o  Department of Defense, and

o  The Federal Trade Commission (FTC).

Thorough understanding of the FDA’s work on food imports

A proper understanding of the way the FDA works with food imports, the regulations it has in place, and its expectations from importers is necessary for individuals and organizations that are connected with FDA food imports in one or another way. This knowledge is needed to help them ensure that their products reach US shores without trouble and get regulatory approval from the FDA.

This is the learning a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.

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; will be the speaker at this webinar. please visit Current and Future Safety Regulations

To register for this learning session and get a thorough understanding of the FDA’s rules and thinking on food imports to the US.

Thorough familiarity of the FDA’s work on food imports

An understanding of the ways in which the various agencies work with the FDA in respect to food imports will be offered at this webinar. An in-depth understanding of this aspect is necessary for those who want to import food to the US and gain regulatory approval for their products, as they have to work with the FDA at various levels.

John Ryan will cover the following areas at this session:

o  Global Food Markets drive new import food safety requirements

o  Review how the FDA’s Food Safety and Modernization Act (FSMA) are changing things

o  Understand “Prior Notice” requirements

o  Foreign Supplier Verification Program (FSVP)

o  Prepare for the Foreign Facility Inspection Program

o  Learn what is in the “Investigations Operation Manual” (IOM)

o  What can happen to your product when seized

o  Learn what other countries require for food import

o  Review the proposed rules for food safety and quality during transportation processes

o  Learn how much food and what food is imported from different countries

o  Understand what the Imported Seafood Safety Program includes

o  PREDICT & OASIS Systems

o  Other resources available to help you.

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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.

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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

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Nitinol-based Medical Devices 2017 Global Market Expected to Grow at CAGR 10.50 % and Forecast to 2021

About Nitinol-based Medical Devices

Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing nitinol-based medical devices, the use of these devices has increased rapidly in the recent years.

Covered in this report

The report covers the present scenario and the growth prospects of the global nitinol-based medical devices market for 2017-2021. To calculate the market size, the report presents a detailed picture of the market by way of study, synthesis, and summation of data from multiple sources.

The market is divided into the following segments based on geography:

• Americas

• APAC

• EMEA

Technavio’s report, Global Nitinol-based Medical Devices Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

Continue here to full Article http://snip.ly/z0mtf

 

 

A clear process for compliant laboratory OOS investigations

The core of successful operation by a drug maker is laboratory testing. current Good Manufacturing Practices (cGMP) regulations require a drug manufacturer to use laboratory testing as a tool to validate that everything that goes into a laboratory product, such as in-process materials, finished materials, and containers adhere to set specifications. When all these are done, a major challenge for laboratories is in how to deal with a test that shows an Out of Specification (OOS) result.

Out of Specification results are viewed very seriously by the FDA

The FDA is uncompromising when it comes to dealing with Out of Specification results in laboratories. Its inspections of laboratory operations are very meticulous. It requires complete adherence to its guidances on how the laboratory has to investigate its Out of Specification and Out-of-Tolerance observations.

The ways by which finished Out of Specification products have to conform to set specifications, safety standards and other quality standards are specified in cGMP regulation Sec 211.165. Any lab whose result fails to do this gets summarily rejected. Another iteration of these cGMP regulations is that any unexplained deviation from the set specifications of a batch or its contents, whose test results show an Out of Specification result, will be subject to thorough investigation. Whether batches have only been manufactured and are yet to be distributed, or already are; the same rule applies.

Ways of dealing with Out of Specification results

This is the protocol that the cGMP regulation makes for dealing with Out of Specification testing:

o  Out of Specification testing is mandatory for the release of a test batch

o  The batch in which an Out of Specification result is confirmed gets rejected

o  The company’s Quality Assurance (QA) will have to state the reasons for the release of a batch that has an element of ambiguity in the result, and has to justify it.

The requirement that current Good Manufacturing Practices need to go into the manufacture of both active pharmaceutical ingredient and finished pharmaceuticals is stated in Section 501(a) 2 (b) of cGMP guidelines on Out of Specification. Also, all aspects such as active pharmaceutical ingredients, raw material testing, in-process and stability testing and Process Validation come under the ambit of the cGMP guidelines.

The FDA guidance on Out of Specification relates to the following products:

o  Human drugs

o  Combination products

o  Biology and biotechnological products

o  Type A medicated articles

o  Transplantation of human tissues

o  Finished products & active pharmaceutical ingredients

o  Medicated feed

o  Dietary supplements

o  Veterinary drugs

Out of Specification needs to be understood fully first

A reading of the above attests to the fact that a thorough understanding of the nature of the issues relating to Out of Specification results needs to be made for a laboratory to meet the required results. All the concerned persons should have complete knowledge of the FDA expectations for Out of Specification results.

It is this knowledge that needs to be applied to put in place procedures that define a complete, scientifically sound investigation of each Out of Specification and Out-of-Trend laboratory observation, as well as for establishing evidence that laboratory personnel conform to the procedures.

A proper learning session on dealing with Out of Specification results

A webinar from Compliance4All, a leading provider of cost-effective professional trainings for all the areas of regulatory compliance, will be providing learning on these aspects.

Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. Please visit Out-Of-Specification Laboratory Results to enroll for this highly educative session.

Tools for dealing with Out of Specification results

The speaker of this webinar will help participants build a basis for the implementation of adequate procedures that help avoid Out of Specification results. He will also review existing procedures and practices. Any laboratory personnel, who need understanding of the steps that a compliant laboratory has to take to handle the investigation of Out of Specification test results, will find this session very useful.

The ways in which the laboratory has to interface with other units through the laboratory investigation process will be explained. The speaker will dwell mainly on the FDA guidance on handling OOS laboratory results and will suggest a clear process for compliant laboratory Out of Specification investigations.

The following areas will be covered at this webinar:

o  Why the regulators are concerned about the handling of OOS investigations

o  The FDA model for handling OOS investigations

o  Commonly accepted terminology such as repeat testing and retesting

o  How the laboratory can meet regulatory expectations for OOS investigations.

o  The interaction between the laboratory and other units in the organization.

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.