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 http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900806SEMINAR?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.

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!

 

 

Management systems should be built on expansiveness and versatility

Management systems should be built on expansiveness and versatility. Only such a system delivers results for an organization. First of all, let us get a basic understanding of a management system: It is a system that helps smoothens and streamlines an organization functioning, enabling it to go on without hiccups.

The purpose of a management system is to put the organization on the road to the destination it has chosen for itself. This is done by instilling a system in which there are a defined set of prescriptive and hierarchical documents, and are well-defined. A prudent management system is one that enables the organization to carry out a host of dispersed functions and activities, so that time and resources are spared.

What an organization’s management system should address is an important question. Ideally, it should consist of a set of standards and practices that addresses all the aspects of the organization’s safety, health and environment management. Such a management system greases the whole process and brings efficiency, consistency, cost-effectiveness and timeliness into it.

A pivot for health and environment management systems

Businesses that use their assets for setting up and creating inputs for the various standards around the functions are effective ones. This is a proven and effective method of optimizing the efficiency of management systems, and becomes the foundation on which decisions concerning the way resources are spent within the Safety, Health & Environment (SH&E) scope of business are made. That is, a management system that becomes a hinge around which an array of functions can be performed is an efficient and effective one.

A proper management system has safety, health and environment at its core. The key to build an SH&E system that is designed along these lines is being able to first thoroughly evaluate their requirements. Organizations also need to have the farsightedness to anticipate the likely changes that could go into these functions over time. The management systems they build must have the strength, resilience and flexibility to absorb these changes. An organization that builds an SH&E system that fails to take these into account is doomed to failure and is sure to be a huge financial burden.

What can a management system that takes SH&E into consideration achieve?

The benefits of building an SH&E-accommodated management system are many. It can be used to or helps in:

o  Identifying everything that has to be managed within the function

o  Constructing a mechanism, tool, or process that manages each of those things identified. These are normally a set of standards, practices and programs that are built specifically for a particular function

o  Building the standard, practice or program so that it can be adjusted according to results

o  Building a measuring metric, benchmark or scorecard with both lagging and leading indicators

o  Building the management system in a way that is hierarchal in structure within the organization – (corporate sets and standards and the business unit builds the practice around the standard)

More on how to build a sound SH&E management

GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will organize a two-day seminar in which the principles to adapt and the thinking needed to cultivate the outlook for building such a management system will be imparted.

The Director of this seminar is James J. Thatcher, President and Owner, Global Safety Solutions LLC., who is listed as an expert witness for operational, as well as safety, health, environmental, training and security issues in the Oil and Gas industry and the mining, minerals and chemical industry. Please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900844SEMINAR?linkedin_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.

In-depth exploration of SH&E management systems

At this seminar, James will make an in-depth exploration of management systems in the health and environmental areas. A complete understanding of SH&E, plus Training and Security (TS), which are the functions around which standards and practices are built, will be offered. He will also offer a description of the 16 functions that cover the SHE & TS world in detail. This learning is important in helping participants understand ways by which to build a standard and practice around all these 16 functions.

The 16 functions that will have a standard and practice specific to the function are:

o  Hazard identification & control

o  Occupational health & industrial hygiene

o  Incident management

o  Emergency preparedness

o  Environmental

o  Regulatory compliance

o  Reporting performance

o  Managing risk

o  Managing safety

o  Management security

o  Verification & audits

o  Document & record management

o  Contractor & service provider management

o  Competency management (training)

o  Commitment, communication and implementation

o  Managing change

In addition, in order to enable clear understanding of the topics, James will also describe the role of supporting documents, associated programs, procedures or Standard Operating Procedures (SOP) that are a part of the particular function being managed,.

How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

 

 

Course “How to build a complete Safety, Health & Environment Management System through Standards & Practices” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Overview:

A management system, by definition, is a process by which a function or functions are carried out in an organization by a series of hierarchal documents that are prescriptive, and set a particular path on which the organization manages its day-to-day operations.

A management system can be for one function, but more often than not, it incorporates many functions. Functions like accounting, engineering, banking, etc. have their own management systems, and the Safety, Health and Environmental, as well as Training and Security should have their own management system. This brings efficiency, consistency, cost effectiveness and timeliness to the entire process.

In order to work effectively, Corporate sets and creates (with business asset) input, the various standards around the functions

The SH&E, plus training and security are the functions we will build the standards and practices around. There are 16 functions that cover the SHE & TS world. We build a standard and practice around all 16 functions. Supporting documents, associated programs, procedures or standard operating procedures (SOP) will be a part of the particular function being managed. The 16 functions that will have a standard and practice specific to the function are:

  • Hazard identification & control
  • Occupational health & industrial hygiene
  • Incident management
  • Emergency preparedness
  • Environmental
  • Regulatory compliance
  • Reporting performance
  • Managing risk
  • Managing safety
  • Management security
  • Verification & audits
  • Document & record management
  • Contractor & service provider management
  • Competency management (training)
  • Commitment, communication and implementation
  • Managing change

Why should you attend :

Every organization in today’s business atmosphere, in order to be competitive and in compliance must have a comprehensive management system in place and operating smoothly. For those companies who do not understand this, the going is much harder and very much more expensive.

The standards and practices that are put in place act as the cornerstone for decisions being made relative to resources and dollars spent within the SH&E scope of business.

This process accomplishes the following:

  • Identifies the things that need to be managed within the function
  • Construct a process, tool, or mechanism that best manages each of those things identified
  • They are usually a set of standards, practices and programs that are built specifically for a particular function
  • Build the standard, practice or program so that it can be adjusted according to results
  • Build a measuring metric, benchmark or scorecard with both lagging and leading indicators
  • Build the management system in a way that is hierarchal in structure within the organization – (corporate sets and standards and the business unit builds the practice around the standard)

 

Areas Covered in the Session:

  • How to build a SH&E management system
  • How to evaluate its effectiveness
  • The tools you need in order to build a SH&E MS
  • How to implement the system with total management support
  • How to develop successful implementation plans, both with management and the workforce
  • How to tell the difference between a standard and a practice
  • How to understand how to design SH&E documents correctly
  • How to assess the risk of not having a MS process in place
  • How to roll the process out
  • How to communicate the process to those who can support the effort

 

 

Who will benefit:

  • EHS Managers, Directors, VP
  • Regulatory Managers
  • Compliance Managers
  • Production Managers, Directors, VP
  • Legal Managers
  • Quality Auditors
  • Operational Leaders (managers, directors, VP)

 

Agenda:

Lecture 1:

Process overview, Main elements of the SH&E MS, Process, infrastructure & system

Internal sources and External sources

What the regulatory agencies are looking for in a SH&E MS

Lecture 2:

System deficiencies

People, process & tools

Lecture 3:

The law perspective & risk analysis

Managing the risks through a systems approach

Lecture 4:

Non-conformance with expectations

Trending for results

Plan-Do-Check-Act

 

Day 2 Schedule

Lecture 1:

Process mapping tools

Creating the Standards & Practices (lots of examples)

Lecture 2:

Continue creating standards & practices

Lecture 3:

SH&E MS plan execution

Communicating the management system

Lecture 4:

SH&E documentation expectations

The MS review & approval process by management

Auditing the MS

How to roll it out – by stages

 

 

Speaker:

James Thatcher,

President, Global Safety Solutions, LLC,

 

James Thatcher the owner and President of Global Safety Solutions, LLC, headquartered in Divide, Colorado. Dr. Thatcher has 35 years of experience in the Oil and Gas, Metals/Minerals and Chemical industry, with management positions in engineering, operations, human resources, safety, health and environment, as well as training and security.

He has a MS in mechanical engineering, and a Ph.D. in psychology/organizational development. He has had many articles published in the Occupational Hazards Magazine, the VPP Leadership Magazine, IADC driller magazine, and through several organizations such as the National Safety Management Society and the World Safety Organization. He has presented at many seminars, summits, conferences, and association meetings for many years.

He is listed as an expert witness for operational as well as safety, health, environmental, training and security issues in the Oil and Gas industry and the mining, minerals and chemical industry. He is recognized in the Safety, Health, Environmental, Training and Security disciplines as an expert in these fields. He was the president of the National Safety Management Society for two terms, and is on their board of directors. He is closely associated with the World Safety Association, and is listed in the United Nations directory as an expert in the field of safety, health, training and security. He was the President of Technical Safety and Training Solutions, Incorporated, and consulted in the United States, Europe and South America.

I offer presentations for EHS conferences and summits, as well as for business group meetings in the area of EHS culture, values, systems, motivation, and inspiration. These messages are both timely and effective in helping to raise the bar in your EHS efforts.

 

 

 

Location: Baltimore, MD Date: April 6th & 7th, 2017 and Time: 9:00 AM to 6:00 PM

 

 

Venue: The DoubleTree Baltimore-BWI Airport

Address: The DoubleTree Baltimore-BWI Airport   890 Elkridge Landing Road – Linthicum, MD 21090

 

Price:

 

Register now and save $200. (Early Bird)

 

Price: $1,295.00 (Seminar Fee for One Delegate)

 

Until February 28, Early Bird Price: $1,295.00 From March 01 to April 04, Regular Price: $1,495.00

 

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

 

 

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