GlobalCompliancePanel Professional Training and Development Courses with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a massive 50% discount!

Yes, that is right. GlobalCompliancePanel’s seminars will be available for a huge 50% discount till March 31. Regulatory professionals who want to augment their knowledge of regulatory compliance can now do so by paying just half the price of these trainings from GlobalCompliancePanel. All that is needed to do walk away with a rare offer such as this is to visit http://www.globalcompliancepanel.com/ and use MGCP50 Promo Code.

This offer is valid till March 31, 2017. Regulatory professionals who want to take any of GlobalCompliancePanel’s trainings can book their trainings for an area of their interest by this date. From April 1 onwards, this offer will cease, meaning that the original price will apply from then.

So, why is GlobalCompliancePanel offering this discount? It is for a simple, but profound reason: It wants to thank its huge customer base for the support they have been extending to this company over the many years for which it has been in business. During the course of the 10 years for which GlobalCompliancePanel has been in business, it has trained thousands of regulatory compliance professionals from around the world.

These professionals, belonging to such varied geographies as the US and Japan and India and Canada, have been able to meet their regulatory compliance challenges on account of these trainings. These trainings are relevant, focused and valuable, and are from some of the best known regulatory compliance Experts found anywhere on this planet.

It is these trainings that have been hoping these professionals in the regulatory compliance arena gain more insights into regulations from the FDA, the EMA and other such bodies around the world. These trainings have been consistently helping them to meet these challenges, as they give them a better and sharper understanding of the implementing these requirements.

These regulatory requirements can pose hurdles to the most experienced and brightest of regulatory compliance professionals in the medical devices, pharmaceutical, life sciences and food and biologicals areas, but not to those who undertake professional trainings from GlobalCompliancePanel. GlobalCompliancePanel’s panel of experts is here to help them overcome these challenges and hurdles.

This trend has been being witnessed from the time GlobalCompliancePanel entered the line of professional trainings. Any wonder then, that no fewer than 50,000 professionals have benefited from these trainings? What could be a better way of thanking such a huge base of customers than with this offer? GlobalCompliancePanel believes that a celebration should also be useful, and this is that this offer is!

Hurry up and enroll today. Happy learning!

GMPs for API Bulk Manufacturers

Till recently, till 2001 that is, Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs) bulk manufacturers was carrying a bulky load on its shoulders, so to speak. GMP for active pharmaceutical ingredients (APIs) per se had no independent guidelines. The GMPs that they were to follow and implement were bunched with those of APIs for bulk manufacturers. So, GMPs for API bulk manufacturers consisted of GMPs for both APIs and API bulk manufacturer.

All that changed, however, in 2001, with the FDA’s issuance of a draft guideline called Q7A, which was meant separately and exclusively for APIs alone. This draft guideline was meant solely for APIs, and GMPs for API bulk manufacturers were exempt from the provisions of the new guideline.

No clear guideline yetThat said, while the FDA draft guidance of 2001 merely separated GMPs for APIs; it did not make any changes to the existing GMPs for API bulk manufacturers, which continued to remain the same and continued to suffer the same insufficiency. The major deficit that plagued GMPs for API bulk manufacturers continued to do so. As in the past, there was no guideline on GMPs for API bulk manufacturers at all. Instead, all that was required was that bulk manufacturers go by their heart. In other words, the onus of maintaining GMPs for API bulk manufacturers was left to them, based on their unique individual needs and situations.

Leaves it to the individual pharma organizationThe FDA and other regulatory bodies merely require that established practices be followed as GMPs for API bulk manufacturers. This, as noted, leaves the task of ensuring that conception and implementation of all-round GMPs for API bulk manufacturers to the individual organization, based on its discretion and assessment of what it deems as appropriate. The following are the areas into which pharmaceutical organizations may take steps at implementing GMPs for API bulk manufacturers:

  • Manufacturing equipment
  • Components that go into the materials and packaging
  • Requirements relating to record-keeping
  • Facilities and buildings
  • Personnel
  • Process controls
  • Laboratory controls

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Article on Effective techniques for extracting information from geochemical data are largely ignored by the industry

In the area of geochemical data analysis techniques and obtaining geochemical extracting information; most mining specialists strongly recommend an approach that goes beyond merely asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis. There, however, exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information. But these are largely ignored by the industry.

As a result of following only one method and technique for geochemical data analysis and obtaining geochemical extracting information, an average geologist is not generally well trained on the necessary techniques and methods. Whenever a request for such data mining techniques analyses comes up, the geologist is short of the techniques and methods needed for geochemical extracting information, including the use of compositional data analysis. This results in failure in the endeavor of extracting all the geochemical data analysis information contained in the data.

Insight into how to use geochemical data analysis techniques and obtaining geochemical extracting information

Noting the deficiency in the methods used for optimal geochemical data analysis techniques and obtaining geochemical extracting information; GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, is organizing a two-day learning session that inculcates the right learning in this area.

At this seminar, Ricardo Valls, a professional geologist with thirty years in the mining industry, will be the Director. He brings the vast wealth of experience of the extensive geological, geochemical, and mining experience, managerial skills, research techniques, and training he has gained by carrying out various projects globally, into this seminar. To benefit from this seminar, please register for it by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900828?linkedin-SEO . This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Simplifying the geochemical extracting information to make sense

Geologists, Geochemists, Exploration personnel, Graduate students and Postgraduate students will find this course very useful, as it will give them an understanding of how to simplify and make sense of the geochemical extracting information. The speaker will demonstrate all types of analyses that can be requested. This will help participants in their exploration goal of finding the new ore body.

This seminar will help mining professionals understand how to extract all the important information of their data, including the use of compositional data analysis.

Valls will cover the following areas at this seminar on obtaining geochemical extracting information:

–       How to determine the type of sampling

–       How to determine the type of assays

–       General processing of the data

–       Compositional Data Analysis

–       Representing the results

In the process of explaining the ways of obtaining geochemical extracting information; Valls will set the following agenda for this seminar:

How to determine the type of sampling

·                    Mechanical anomalies

·                    Chemical anomalies

·                    Chemo-mechanical anomalies

·                    Scale of work

How to determine the type of assays

·                    What are you looking for?

·                    What the laboratory can offer?

QA&QC in the field and in the laboratory

·                    QA&QC in the field

·                    QA&QC in the laboratory

General processing of the data

·                    Preparing the data

·                    The problem of zeros and b.d.l. data

·                    Hurricane values

·                    Distribution law

·                    Preparing the data for further analysis.

Compositional Data Analysis

·                    Brief introduction

·                    Comparing CDa with normal statistics

·                    ALR

·                    CLR

·                    ILR

Processing major elements

·                    Statistical processing

·                    Determining the most probable magmatic event.

Processing trace elements

·                    Statistical processing

·                    Estimating the erosional level

·                    Determining geochemical indexes

Graphical representation of the results

·                    Variograms

·                    SURFER

Unravelling the DHF, Technical File and Design Dossier

technical

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD.

The Design History File

The history of the Design History File is an interesting one. It evolved out of the FDA’s realization, over time and experience; that the major part of a device’s problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.

 

dhftechnicalfileanddesigndossier

Outstanding characteristics of the Design History File

dhftechnicalfileanddesigndossier1

What should the Design History File contain?

The DHF should contain the following:

dhftechnicalfileanddesigndossier2

 

Now, the Technical File and Design Dossier

In short and simple terms, one can understand the Technical File and the Design Dossier as the EU’s version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.

What should the TF and DD contain?

These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company’s “Declaration of Conformity” for that product:

  • General Information/Product Description/EC Authorized Representative
  • Classification Determination
  • Essential Requirements
  • Risk Analysis
  • Labeling
  • Product Specifications
  • Design Control
  • Clinical Evaluation
  • System Test Reports
  • Functional Bench Testing
  • Lab Testing
  • Sterilization validation (or AAMI TIR 28 Analysis)
  • Packaging Qualifications
  • Manufacturing
  • Sterilization
  • Conclusion
  • Declaration of Conformity
  • Appendix

Differences between the Technical File and Design Dossier

At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices

While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.

 

Learn more on this topic by visiting  :  http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900746SEMINAR?wordpress-SEO

 

 

Article on FDA 21 CFR Part 11 Compliance

FDA-regulated industries electronic signatures and other records are considered authentic. From 2007, a strong body of opinion has emerged challenging the stringency of these requirements, but nothing major has been diluted from these.

The regulations under FDA 21 CFR Part 11 Compliance set out criteria that the Food and Drug Agency (FDA) considers in order to deem electronic signatures authentic. The electronic records, electronic signatures, and handwritten signatures executed to electronic records of several FDA 21 CFR Part 11 Compliance sets out benchmarks by which FDA-regulated industries have to be compliant with the standards set out in FDA 21 CFR Part 11 Compliance to prove that these are authentic, safe and trustworthy. The operative factor is that the FDA has to consider these signatures as being on par with those done on paper.

Which industries are included in FDA 21 CFR Part 11 Compliance?

FDA 21 CFR Part 11 Compliance applies to nearly all FDA-regulated industries, including but not restricted to:

  • Medical device manufacturers
  • Drug makers
  • CROs
  • Biotech companies, and
  • Biologics developers

The Aim of FDA 21 CFR Part 11 Compliance

The aim of FDA 21 CFR Part 11 Compliance is to ensure that specified FDA-regulated industries such as those mentioned above (with specific exceptions) implement controls -which could include audits, audit trails, documentation, system validations, and electronic signatures -for software and systems involved in processing electronic data that are:

  • Required to be maintained by the FDA predicate rules or
  • Used to demonstrate compliance to a predicate rule. The FDA describes a predicate rule as any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. FDA 21 CFR Part 11 Compliance also applies to submissions made to the FDA in electronic format, such as a new drug application.

Which industries are exempt from FDA 21 CFR Part 11 Compliance?

Interestingly, exceptions are allowed within the same industry, based on the format of filing. For example, while FDA 21 CFR Part 11 Compliance applies to submissions made to the FDA in electronic format; it does not apply to a paper submission for the same made in electronic format, such as fax.

Also, FDA 21 CFR Part 11 compliance is not required for record retention for trace backs by food manufacturers. Similar to the logic used in the mode of filing as noted above; most food manufacturers are not otherwise explicitly required to keep detailed records, but when organizations keep electronic documentation for HACCP and similar requirements; this documentation must meet these requirements.

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Preparing premarket submissions that win regulatory approval

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket submissions that win regulatory approval challenging? It is the fact, acknowledged by the FDA itself, that the PMA is the most stringent type of device marketing application required by the FDA. The PMA should be secured from the FDA before the company markets the medical device. The FDA gives its approval of the PMA for a Class II medical device only after it determines that all the elements necessary for assuring that the application has enough scientific confirmation that it is safe and effective for the intended uses it is going to be put to. Preparing premarket submissions thus is an onerous task by any stretch of imagination.

Another element of preparing premarket submissions that win regulatory approval

Another aspect of preparing premarket submissions is the 510 (k). The 510 (k) is essentially a kind of premarket submission that is made to the FDA to show that the device that a manufacturer intends to market is at least as effective and safe as a legally marketed device of its equivalence, already in the market, that is not subject to PMA. The FDA calls this principle the substantial equivalency (SE) and the device that is used as the reference for equivalence, the predicate device. The requirements governing SE are contained in 21 CFR 807.92(a) (3).

On top of all these, regulatory professionals have the responsibility of creating preparing premarket submissions that should not only convincingly demonstrate the ways of stating and explaining regulatory arguments for their device to the U.S. FDA reviewer for getting the approval; they should also be presentable and well-organized, without being cluttered or confusing.

Professional trainings for preparing premarket submissions that win regulatory approval

Given all these, it goes without saying that a completely thorough understanding and knowledge of the relevant U.S. FDA laws, regulations and requirements is absolutely necessary for regulatory professionals. This in-depth understanding can be had only from thorough training, which is indispensable if the medical device company is to win a clearance or approval.

The ways by which to do this is the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will impart. The Director of this seminar is Subhash Patel, a very senior regulatory professional and founder of New Jersey-based MD Reg Consulting LLC, which serves medical device industry clients in all aspects of global regulatory affairs specific to their needs.

To enroll for this highly valuable training session on how to successfully prepare 510(k)/Pre-IDE/IDE and PMA premarket submissions that secure clearances and approvals from the FDA, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900776SEMINAR?wordpress-SEO .  This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

The grasp needed for preparing premarket submission that win regulatory approval

At this seminar, Patel will demonstrate the grasp that regulatory professionals in the medical devices industry need for working with the FDA officials during the review and approval process of their submission. He will offer a complete understanding of the major aspects of FDA premarket submissions.

While knowledge of the regulatory process is one thing; medical device companies also need to know how to set and state regulatory arguments for their device in a most convincing manner to the FDA reviewer. This knowledge will be part of this course. In the process of explaining how to prepare premarket submissions that win regulatory approval; Patel will also offer tips and suggestions to participants on how to work effectively with the U.S. FDA officials during review and approval process of their submission.

During the course of these two days, Patel will cover the following core elements of how to prepare premarket submissions. He will explain the following:

o  History and background of U.S FDA Laws and Regulations

o  Classify Your Device

o  Choose the Correct Premarket Submission for your device

o  Compile the Appropriate Information for your Premarket Submission

o  Author and Prepare your Premarket Submission

o  Submit your Premarket Submission to the FDA

o  Interact with FDA Staff during Review and Approval

o  Complete the Establishment Registration and Device Listing

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

Standard Operating Procedures are crucial documents in the regulatory industry

 

Standard Operating Procedures (SOPs) are very important documents that can make or break an organization in the regulatory industry. In simple terms, a Standard Operating Procedure, as suggested in its nomenclature, is a description of a specific operational procedure in which all the activities necessary to complete tasks that conform to established best practices, set regulatory requirements for the particular industry, and the relevant State or local laws provincial laws are explained. Many a time, a Standard Operating Procedure can be just a description of the organization’s own mode of doing things related to its business.

So, this description leads to the fact that since a Standard Operating Procedure is a detailed description of how things are to be done by an organization; any such document in the medical devices industry contains a list of step-by-step procedures the manufacturing organization lays down for producing its products. In a larger sense, an SOP is a complete depiction of all the practices followed by a business that has to meet the required quality and regulatory standards.

Get trained on how to write Standard Operating Procedures effectively

Given the acute importance of Standard Operating Procedures; it is important for regulatory professionals to get a clear idea of how to approach them by getting a thorough understanding of this concept. A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is being organized to give a thorough understanding of how to write Standard Operating Procedures effectively for the medical devices industry.

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, who has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and who manages activities within the global regulatory and compliance space; will be the Director of this seminar.  To gain a clear understanding of the topic of Standard Operating Procedures for the medical devices industry, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900760SEMINAR?wordpress_seo . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A clear clarification of all the major issues and aspects relating to Standard Operating Procedures will be one of the core purposes of this seminar. Writing a Standard Operating Procedure should be simple, or at least, that is what it appears in theory. In reality though, writing Standard Operating Procedures or procedural documents is quite challenging in the regulated industries, because the Standard Operating Procedures have to take a whole host of procedures, processes, practices and factors into consideration.

The FDA requires “proof of establish” for writing Standard Operating Procedures

In order to make this easier, the Director of this seminar will make the participants of this seminar understand the cornerstone of writing Standard Operating Procedures, which for the medical devices industry, is what the FDA calls “proof of establish”. This is the foundation of FDA regulations and guidance documents for this industry, and consists of the entire array of activities pertaining to the practice of how to define, document (in writing or electronically) and implement that which is written.

Once this rationale for the Standard Operating Procedures is clear, the step-by-step set of instructions needed for performing a particular job or task in the regulated industries flows more easily.  This is the teaching David will instill at this seminar on Standard Operating Procedures.

Writing Standard Operating Procedures is not the end; implementing what is written is

This said, writing the set of Standard Operating Procedures is by no means the end of the work for regulatory professionals. Implementing that which has been created and are in the process of being created is much more vital. David will offer understanding of this aspect by presenting topics associated with how to write, format, execute, manage and globally harmonize Standard Operating Procedures. This is going to be explained keeping in mind the fact that SOP’s are the most popular documents audited by FDA and other Agencies, as well as by auditors and customers.

Standard Operating Procedures and GDP

This seminar on Standard Operating Procedures will also give a detailed understanding of Good Documentation Practices required by companies to ensure GMP compliance and the role played by Standard Operating Procedures in helping achieve the required level of compliance and quality.

This seminar will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The Director will show recent enforcement actions for Standard Operating Procedures related violations, most of which are documentation related. He will also emphasize the fact that Standard Operating Procedures work best when they are designed to achieve specific results, and will teach participants the ways by which to determine what business goals will be achieved through better management with Standard Operating Procedures and how those goals will be measured.

https://www.brampton.ca/EN/Business/BEC/resources/Documents/What%20is%20a%20Standard%20Operating%20Procedure(SOP).pdf