Applied Statistics for FDA Process Validation

The pharmaceutical industry considers Applied Statistics for FDA Process Validation to be of very high importance. In 2011, the FDA set out this guidance for the industry. as part of this guidance, called “Process Validation: General Principles and Practices”, which sets the framework for Process Validation in the pharmaceutical industry, any organization in the pharmaceutical industry has to set up a three-stage process.

These are the three stages:

I.           Process Design

II.           Process Qualification, and

III.           Continued Process Verification.

Stage 1, or what is called the Process Design stage, is the stage in which the commercial manufacturing process is defined. This definition is based on knowledge gained through development and scale-up activities.

Stage 2, called the Process Qualification, is the stage in which an evaluation is made of the process design to determine if the process is capable of reproducible commercial manufacturing.

Stage 3, the Continued Process Verification, is meant for giving ongoing assurance during routine production to ensure that the process remains in a state of control.

A seminar on the ways implementing Applied Statistics for FDA Process Validation

GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing a two-day seminar in which the ways of using Applied Statistics for FDA Process Validation will be taught. Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director of this seminar on applied statistics for FDA Process Validation.

In order to learn Applied Statistics for FDA Process Validation in-depth, please register by visiting Applied Statistics for FDA Process Validation. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A detailed and methodical approach to implementing statistical methodologies

This two-day course on Applied Statistics for FDA Process Validation will focus on the ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.

Beginning with a primer on statistics, Dr. Burdick will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.

Dr. Burdick will next move on to explaining the two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays).

He well then show how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Given that the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.

This seminar on Applied Statistics for FDA Process Validation will lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.

All-round learning related to Applied Statistics for FDA Process Validation

Dr. Burdick will teach participants how to:

o  Apply statistics for setting specifications

o  Assess measurement systems (assays)

o  Use Design of Experiments (DOE)

o  Develop a control plan as part of a risk management strategy, and

o  Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although established for the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation also provides a useful framework for other related industries.

In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

o  Apply statistics to set specifications and validate measurement systems (assays)

o  Develop appropriate sample plans based on confidence and power

o  Implement suitable statistical methods into a process validation program for each of the three stages

o  Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)

o  Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ

o  Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

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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 April 30. 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 https://www.globalcompliancepanel.com/seminar?wordpress_SEO and use MGCP50 Promo Code.

This offer is valid till April 30, 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!

 

 

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/