Successful completion of Singapore Seminar by NetZealous on the topic “Why is FDA at my Facility, and what do I do During an Inspection” by David R. Dills

Fremont, CA, Jul , 19 2016: A highly interactive two-day seminar on the topic, “Why is FDA at my Facility, and what do I do During an Inspection”, was organized in Singapore by NetZealous, a leading Provider of Regulatory Compliance Trainings for a wide range of regulated industries on July 18th & 19th, 2016. The Speaker at this seminar was David Dills, Regulatory Affairs & Compliance Consultant.

Why is FDA at my Facility, and what do I do During an Inspection2

This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.

This presentation will review and emphasize the do’s and don’ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483’s and Warning Letters. Emphasis is placed on the company’s SOP on dealing with inspectors and knowing how to be prepared, proactive…and being able to defend and justify… and what it takes to achieve a favorable outcome.

Why is FDA at my Facility, and what do I do During an Inspection1

This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

More details about the seminar can be had from http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900547

About the Director:

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, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space.

He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements.

About NetZealous:

NetZealous, a Fremont, CA-registered organization, DBA  GlobalCompliancePanel offers a broad range of high quality regulatory and compliance-related professional trainings and services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biological, drugs, food and biotechnology.

CEO of NetZealous, Satisha Naraharimurthy, has expressed his happiness and satisfaction that this seminar was held at a time when laboratories are seen to be struggling with their core issues relating to equipment qualification, calibration and computer system validation processes. He is satisfied that his organization served an important learning need for such professionals.

An understanding of what laboratory professionals need to do in order to meet regulatory requirements was what this seminar intended to impart, and it has done its job rather well, felt Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous.

The learning gained at this two-day seminar, which was packed with both substance and articulation, will go a long way in helping laboratory personnel at various levels understand ways by which to sort out the issues they have in relation to equipment qualification, calibration and computer system validation processes, believes Liju Mathew, Co-Founder and Chief Business Development Officer at NetZealous.

Contact information:

Call: 1-800-447-9407;

Visit: http://www.netzealous.com/

Statistical Considerations for ICH Guidelines

Statistical Considerations for ICH Guidelines

This unique hands-on course will provide attendees with an understanding of how to apply to Statistics to the ten ICH Quality guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.

How well do you understand how you can utilize statistics to address the ICH guidelines? Most organizations have programs and procedures but fall short in the implementation of the tool and techniques used to apply the appropriate statistical tools.

This 2 day hands-on workshop explores the unique challenges facing all facets of a pharmaceutical and biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage and mitigate risk of poorly designed studies. Participants will learn the major aspects of the statistical methods and discover how organizations and external authorities expect organizations to meet these guidelines.

More Info Click Here

Understanding the calibration curve

To get an understanding of instrument calibration, we can think of it as being an essential phase in most measurement procedures. The calibration curve is a set of operations with which the relationship between the outputs of the measurement system (for example, the response of an instrument) and the accepted values of the calibration standards (for instance, the amount of analyte it has) can be established. Understanding the calibration curve is important because this is required in a large number of analytical methods.

How to go about a calibration curve?

At its most basic form, understanding the calibration curve has to begin with the preparation of a group of standards which contain a known amount of the analyte of interest. In this, the instrument response for each standard has to be measured. In addition, the relationship between the instrument response and analyte concentration has to be established. This relationship is then used to transform measurements made on test samples into estimates of the amount of analyte present.

The calibration process

In understanding the calibration curve, we have to know that a number of stages go into calibrating an analytical instrument. This is how a logical sequence of steps would look:

  • Planning of the experiments;
  • Making the relevant measurements;
  • Plotting the results;
  • Carrying out regression analysis on the data, which will help obtain the calibration function;
  • Assessing the results of this regression analysis;
  • Using the calibration function to estimate the values of the test samples;
  • Evaluating the ambiguity of the values obtained

References:

http://www.nmschembio.org.uk/dm_documents/lgcvam2003032_xsjgl.pdf

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Technical file vs design dossier

One of the important points that a medical device professional encounters is this: the technical file vs design dossier. The reason for the confusion about these two is that there are different names of the same concept and vary according to the class of device and the Notified Body that approves it. This is what has given rise to the technical file vs design dossier.

Depends on class of device

At a basic level, there is a difference between the two: the medical device manufacturer must have technical documentation for each device. Called the conformity assessment annex of the MDD, IVD and AIMD directives; this is a basic requirement of these regulatory bodies and statues. The important element of the technical file vs design dossier aspect is that the terminology technical file/design dossier sometimes varies depending on whom the directive has come from, and the annex in which it is placed. This is why there is some confusion on this technical file vs design dossier matter.

The two terms are interrelated

The following description should give a perspective: by the term “technical file” is meant the description of the documentation that demonstrates the ways by which the device complies with essential requirements. Among these devices, some devices require a design examination. The Technical Construction File (TCF) of such devices is called a design dossier. This explains the fundamentals of the technical file vs design dossier debate.

Depends on the Notified Body

To recap, the technical file, which the MDD refers to as “technical documentation”, is a bunch of documents that the medical device manufacturer has to put in place and furnish to their Notified Body for assessment. This is to show that the medical device conforms to the Essential Requirements of the directive. While this much is clear, some Notified Bodies require different methods of documentation for certain class of medical devices. These are to be presented as a design dossier. This is what has given rise to some confusion about the technical file vs design dossier issue.

Reference:

http://www.tuvamerica.com/tuvnews/newsletters/searchdetail.cfm?ID=552

http://elsmar.com/Forums/showthread.php?t=28968

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Supplier quality audit training

Most medical device companies have auditors that assess the quality of the product from the supplier. This is the supplier quality audit. Supplier quality audit training is the training that is needed to be qualified to assess the quality of a product from the supplier. Auditors, regardless of whether they are from inside the organization or are external; have a need for this kind of training.

What are the attributes of an effective supplier quality audit training?

For a supplier quality audit training to be effective, it has to ideally combine theoretical and practical aspects of supplier quality audit. Auditing staff that undergo training must ideally be made to carry out a number of assignments in the area of regulatory compliance relating to supplier quality audit. This will give them enough knowledge of how the course aspects of supplier quality audit training work in real life.

What types of audits can supplier quality audit training help an auditor perform?

When proper supplier quality audit training is imparted, auditors in the organization or outside can perform the following types of audits:

  • New supplier audits
  • Existing supplier audits
  • Time cycled audits
  • Internal audits
  • Audits specific to a task or cause

Areas of supplier audits

There are specific areas that supplier audits work in. The aim of supplier quality audit training is to identify these and help auditors carry the audits out in their respective areas:

  • Regulatory
  • Quality
  • Operations
  • Business
  • The supplier audit process

Effective supplier quality audit training will help auditors carry out two important types of audit:

  • Top-down, which is an ISO-type of audit that is concerned with recordkeeping and Quality System documentation
  • Bottom up, a style of audit in which specific quality deficiencies are identified and rectified. This is usually referred to as the FDA type.

References:

http://www.nixonpeabody.com/files/Supplier_Quality_Mailhot.pdf

 

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539

Supplier qualification program

In the pharmaceutical and life sciences industries, a sound supplier qualification program is a must. It is an indispensable element of their very reputation. Many pharmaceutical organizations contract several of their manufacturing processes or even products to third parties. For this reason, the FDA considers the supplier as a logical extension of the manufacturer. In fact, it attaches so much importance to this area that it holds the pharmaceutical organization (the contracting company) responsible for the supplier’s behavior in relation to the manufacturer’s product

The FDA can inspect the supplier’s facility too

Since the supplier is considered a part of the manufacturer’s operations, the FDA reserves the right to inspect the supplier’s facility too, at the time of carrying out an inspection of the pharmaceutical organization. This being the importance of the supplier, it is imperative to chalk out an effective supplier qualification program that meets regulatory requirements.

Supplier evaluation

A supplier qualification program starts with supplier evaluation. Obviously, the supplier and his facilities have to be inspected according to predefined parameters. This will enable the pharmaceutical organization to clearly state the terms of the contract. The contract should ideally specify the conditions in which the pharmaceutical product is going to be made.

Key elements of a sound supplier qualification program

All the important aspects of a supplier qualification program have to be put in place, as should the kind and nature of control. There should be proper checking up of data that goes into the supplier qualification program. These are some of the aspects that need to be implemented:

  • Establishment and maintenance of data that clearly describe or reference the specified requirements, among which quality requirements are very important
  • Identification of the key elements of a strong, sustainable and successful supplier qualification program
  • Signing of terms of the contract and making written agreements of the same, in which all the conditions of work will be clearly specified and ensure that the supplier meets the quality requirements consistently
  • Ensuring that the supplier qualification program has processes that are important to quality. This should also define how conformance to manufacturer requirements will be monitored and verified.

Reference:

http://www.eventbrite.com/event/5766556927/eorg

Contact Detail
GlobalCompliancePanel
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone:800-447-9407
Fax:302-288-6884
43337 Livermore Common | Fremont| CA | USA | 94539