Safety Management and OSHA Compliance

Why is Occupational Safety and Health Administration (OSHA) compliance necessary? For a simple reason: OSHA compliance is the surest legal way of ensuring safety at the workplace. Safety management and OSHA compliance go hand in hand and are deeply connected to and intertwined with each other. Safety management is at the core of OSHA and is the very purpose for which OSHA regulations were legislated. This is why safety management and OSHA compliance are so strongly related to each other.

Construction Goggles

OSHA has regulations for ensuring the safety of workplaces in almost any industry that one can think of. Compliance with these regulations is necessary for not only ensuring the safety of workers at the workplace; it is also necessary to avoid paying hefty fines that noncompliance results in. knowledge of safety management and OSHA compliance and the way they work is crucial for any company for these core reasons:

• Violation of any relevant OSHA regulation leads to high penalties in the form of fines. Such an organization can also expect to face suspension of their activities

 

• A safety management program as part of OSHA compliance ensures that the organization cuts down on its costs significantly

 

• More than anything else, an organization that violates the provisions and requirements of OSHA can become responsible for employee injuries and even death at the workplace. Such an organization faces additional costs. Its production capabilities suffer, leading to delayed output.

 

A full understanding of safety management and OSHA compliance

It is to familiarize organizations with all that is necessary for ensuring safety management through OSHA compliance that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar. This seminar’s speaker is Keith Warwick, who is President, Patty & Keith Inc. Keith, a licensed professional engineer in California, who has been licensed in Tennessee, Indiana, Illinois and New York; is the author of California’s Highway 99: Modesto to Bakersfield.

To gain learning from Keith on the way in which safety management and OSHA compliance are related to each other, please register for this seminar by visiting Safety Management and OSHA Compliance This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Key seminar takeaways

The main benefit this seminar will impart is that it will offer to participants the ways by which to develop a safety program that will help them save costs associated with delays in schedules and the human cost of injury or death. In the course of narrating this major benefit, Keith will also show explain the following:

• Safety management guidelines and techniques for the engineering, construction, and scientific professions
• The costs of preparing the necessary safety documentation
• Using multiple techniques for each safety task
• Costs of professional services from consultants
• The costs of accidents in an occupational environment
• The costs associated with operating industrial and construction projects safely in accordance 29 CFR 1910 and 29 CFR 1926
• The way in which environmental releases and safety violations can impact an organization’s profitability
• How accidents affect production schedules and result in civil or in some cases criminal action: Multiple safety violations can cost organizations hundreds of thousands of dollars.
• Upper management’s commitment to an environmental and safety compliance program.

Keith will show participants how to develop a safety inspection protocol that will help reduce the risks of environmental incidents and accidents. All these will be peppered with a brief exercise on each of the two days.

This detailed presentation of all the aspects of safety management and OSHA compliance will be of great value to professionals related to safety and its upkeep, such as Owners, Managers, Safety Managers, Environmental Compliance Managers, Engineers, Architects and Landscape Architects.

Keith will cover the following areas at this seminar:

• Chemical safety
• Developing a safety management program
• Safety aspects of environmental compliance
• Confined space safety
• Introduction to OSHA
• Office safety
• Hazardous communications
• Safety Data Sheets
• DOT hazardous material classes and divisions.

Documenting Software for FDA Submissions

The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing. Healthcare is one of the many areas in which the Agile methodology is very well suitable and adaptable.

The Agile methodology can be used to help software project managers forestall and address major bottlenecks of software project management, such as vulnerability and mercuriality. It helps to prevent project delays and thus cuts costs. An important feature of Agile is its flexible nature, which gives it the ability to accommodate and ingest many new changes that take place as the project develops.

In reviewing project progress at every stage by validating roles, steps and processes functions; Agile prevents piling of work at later stages of the project. Protect managers have reiterated time and again the ability Agile has in the background of severe constraints of time and money.

Agile has its drawbacks

However, this is not to suggest that all is well with Agile, and that it works in every setting and in every situation. For Agile to work efficiently and to deliver the results it sets out to; the most essential precondition is thorough and complete, tightly knit team coordination. It requires very active and strong participation from the team leaders, subject matter experts and stakeholders.

The suitability that Agile has for the healthcare industry is well-established. But, being a highly teamwork-dependent initiative; Agile also has the potential to fail in situations in which all the factors that make it work fail to gel or synchronize. Unless those in the healthcare industry who want to use Agile methodology as a means for saving money, time and other resources are confident that they can bring together all that is needed for making Agile methodology useful and effective; it is not going to be of much use.

A learning session on the applicability of Agile methodology to healthcare

So, how does the healthcare industry adapt Agile methodology for its use? How does it overcome the deficiencies and shortfalls of this methodology to optimize its use and leverage it for better results?

An in-depth exploration how Agile methodology can help in documenting software for FDA submissions will be the core learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

Brian Shoemaker, who consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures, and has worked with companies in Germany and Switzerland as well as the U.S., will be the Director of this seminar. Please visit Documenting Software for FDA Submissions to enroll for this seminar. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarification of doubts about the suitability of Agile to IEC 62304

At this seminar, Brian will clarify the criticism in healthcare software industry circles that Agile, because of its lack of documentation runs counter to the lifecycle standards mandated in IEC 62304. He will explain how clear processes for quality management system, risk management process, software maintenance, configuration management, and problem resolution, which go into the IEC 62304 principles actually strengthen, rather than weaken or controvert the Agile methodology. In fact, as the AAMI Agile report (TIR 45) has stated, the proper application of Agile, with its emphasis on nimbleness and ongoing learning, into a quality system and safety risk management can meld with and facilitate in fulfilling regulatory expectations of well-documented development.

In fact, documentation in Agile actually helps in taking advantage of iterative development. This is because since the IEC 62304 does not specify any lifecycle model; documentation can grow out of the required iterative activities. By developing incrementally and helping prevent last minute anxieties and worries; Agile is highly useful in many disciplines of healthcare. Its use for hazard analysis is extremely well suited. This makes risk management more robust by being included in iteration tasks.

In all, this will be a highly educative session at which all the aspects relating to the applicability of the Agile methodology to software documentation for FDA submissions will be explained. Brian will cover the following areas at this seminar:

• Agile vs IEC 62304: an apparent contradiction?
• The role and value of documentation
• The REAL regulatory requirements
• Specific documents required for an FDA submission
• Areas where most development processes bog down
• Iteration – well suited for risk, usability, and design reviews
• Key practices to bridge the Agile and regulated worlds
• Agile is not only acceptable for medical device software, but can be clearly superior.

 

All about biosimilars –from development to registration

Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.

There is a misconception that they are similar to or are the same as generics, but this is not so in reality. Generics differ from a biosimilars in one major sense: While a biosimilar is only highly similar to the original product (called the reference product); a generic is the exact replica of the original, whose chemical structure it takes. Further, there is a difference in the ways they are manufactured, their complexity (generics are small and biosimilars, big), and the data each is required to furnish for gaining approval.

The regulatory requirements for gaining approval for biosimilars are considered complex. Different approaches are used in different regions around the world.

Exploration of all aspects of biosimilars

Professionals in the areas of biological sciences, who deal with biologics, need to have complete knowledge of the whole host of issues associated with biosimilars, ranging from their manufacturing process to regulatory guidelines. Given the complex nature of the science and the approval process; lack of in-depth knowledge can result in their application getting rejected by the regulatory authorities.

It is to help avoid these situations that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar. The aim of this seminar is to offer complete understanding of the topic of biosimilars, from its clinical aspects to what it takes to gain approval, and a whole host of other issues relating to biosimilars.

The Director of this seminar is Salma Michor, Founder and CEO of Michor Consulting Schweiz GmbH. Salma teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. Michor Consulting Schweiz’s clients include Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. To gain the immense benefits this seminar offers, please register by visiting  All about biosimilars –from development to registration This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Discussion of all the areas relating to biosimilars

The FDA’s approval process for biosimilars is quite complex. If a biosimilar product has to gain FDA approval, it has to show that it is highly similar to an FDA-approved reference product. It has to show that the biosimilar product has no substantial deviation from the reference product in terms of effectiveness and safety. If there are differences, the company has to show that these are within the permissible limits allowed for the product.

The Affordable Care Act of 2010 made a few amendments into the way the Public Health Service Act (PHS Act) creates an abbreviated licensure pathway for biosimilars which are “biosimilar” to or are “interchangeable” with an FDA-approved biological product. This has to be in the manner described in the Biologics Price Competition and Innovation Act (BPCI Act).

An interchangeable biosimilar product is one that can be interchangeable with the reference product. That is, it can be substituted for the reference product without the advice of the prescriber. This means that the interchangeable biosimilar has met the FDA-approved reference product’s standards, as well as additional standards required for it to show interchangeability.

Complete understanding of the process relating to biosimilars

Over the two days of this seminar, Salma will help participants understand all the aspects relating to biosimilars. She will explain the challenges and choices that professionals in the field of biosimilars are up against. Biosimilar legislation in the US and the EU, the ways of establishing Target Product Profile (TPP) for a biosimilar, preclinical aspects, and quality, stability and preclinical testing will all be covered.

The Director will also lead participants into an exploration of the Phase I and Phase III clinical aspects relating to biosimilars, the existing guidelines on clinical testing and safety, registration process under the EMA, and market access for biosimilars in the US and Europe. She will intersperse these topics with relevant case studies.

This two-day seminar will offer value to those who deal with biosimilars in their work. These include Regulatory Affairs, Medical Officers and Clinical Trial Managers.

Salma will cover the following areas at this seminar:

• Design and TPP
• Pre-clinical testing and comparability
• Clinical testing
• Analytical studies
• Stability of biosimilar products.

 

 

HIPAA compliance expectations from Small Healthcare Providers

For The Health Information Portability and Accountability Act (HIPAA), the Business Associate is a major component. According to HIPAA, a Business Associate (BA) is an organization or a person who works with or provides service to a Covered Entity. A CE is one who handles or discloses Protected Health Information (PHI). This makes a Business Associate any person or entity that is involved in creating, receiving, maintaining or transmitting PHI to a CE for a purpose or activity or function as mandated and regulated by the HIPAA Privacy Rule.

Small businesses struggle with meeting HIPAA requirements

There are specific requirements that small healthcare practices need to put in place and to show that their program is current and meets the regulatory requirements set out in HIPAA. They need to conceive and implement a HIPAA compliance program that meets the requirements set out in this legislation. The compliance program should not only be adequate; it should be robust and resilient enough to withstand HIPAA’s strict scrutiny at various levels.

Helping small healthcare providers with the knowledge and skill needed for meeting HIPAA requirements is the purpose of a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. At this seminar, Jay Hodes, who is a leading expert in HIPAA compliance and President of Colington Consulting, which provides HIPAA consulting services for healthcare providers and Business Associates, will be the Director.

Want to get a complete understanding of the requirements that small healthcare providers need to meet to comply with HIPAA requirements? Just register for this learning session by visiting HIPAA compliance expectations from Small Healthcare Providers.

Full explanation of what all a small business provider needs to do

This seminar is particularly created for small healthcare providers who have a difficulty in understanding the HIPAA compliance requirements and meeting them. It will be useful for those of various business sizes, but is primarily focused on the small healthcare provider. Jay will impart the kind of teaching with which organizations will be able to meet all of the HIPAA, HITECH, and Omnibus Rules.

The basis to implementing the requirements of compliance program is to first fully understand them. This is the learning that this seminar will offer. At the end of two days of intense learning that will be interspersed with lively presentations; participants will have inculcated a full grasp of all of the requirements for a comprehensive HIPAA compliance program. They will also have got a clear understanding of the kind of steps that they need to take to mitigate risk.

Steps needed to develop, review and amend HIPAA

The Director will include practical exercises over these two days that will help participants know all that is needed for developing, reviewing, and amending HIPAA policy and procedure. He will equip the participants with a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations.

Over the two days, Jay will cover the following areas:

o  Why was HIPAA created?

o  Who Must Comply with HIPAA Requirements?

o  What are the HIPAA Security and Privacy Rules?

o  What are the Consequences of being a Business Associate

o  What is a HIPAA Compliance Program for a Business Associate?

o  What is a HIPAA Risk Management Plan?

o  What is a HIPAA Risk Assessment?

o  What is the Role of the HIPAA Security Official?

o  What are HIPAA training requirements?

o  What is a HIPAA data breach and what happens if it occurs?

o  What are the penalties and fines for non-compliance and how to avoid them

o  Case Examples of HIPAA Data Breaches

o  Creating a Culture of Compliance

o  Q&A.

Change Control is at the core of GMP Compliance

Change Control is among the areas for which the highest numbers of FDA 483’s get issued. Documentation and evaluation of Change Control are of critical importance to an effective Quality System program. Along with Out of Specification, Change Control has been a regular in the list of the 10 most cited GMP regulations for the past five years. If the nature and number of these citations are any indication, there is no reason to believe that this is going to change.

What happens when the FDA issues 483’s or take other types of penal actions against companies? There could typically be recalls, penalties and even resignations of personnel who hold high positions in the company. Yet, it is the company itself that is to blame for inviting citations from the FDA. If they have an understanding of how to handle Change Control and OOS properly and know how to document them, they can hold their head high and confidently go about their business.

Getting Change Control documentation right

Documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents are imperative to an effective quality system program, along with several regulatory requirements.

Controlling this process requires one to have a defined Change Control procedure that outlines responsibilities and documentation requirements, along with a form in which to record required information.

The success of a Change Control program and its ability to assure regulatory auditors that the laboratory’s equipment, utilities and systems remain in a state of control are determined by the effectiveness of these items.

A full and in-depth understanding of Change Control 

All the aspects of Change Control, its documentation and the ways of handling OOS will be the teaching a seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.

Kenneth Christie, who is the chief operating officer for VTS Consultants, Inc. and has over three decades of experience in sterile manufacturing and regulatory GMP consulting in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries, will be the Director of this seminar.

In order to gain complete knowledge of all the aspects of Change Control and OOS, please register for this seminar by visiting Change Control is at the core of GMP Compliance. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Focus on the major aspect of Change Control and documenting it, and handling OOS

At this seminar, Kenneth will concentrate on three major points:

o  The regulatory requirements for Change Control, along with what this change applies to

o  The ways of developing a Change Control SOP that will define what is required, along with the responsibilities, and how to quickly provide summaries of changes to investigators

o  Some of the common deficiencies cited by regulatory auditors.

Leading to insights needed to ask the right questions

Kenneth will also offer insights into the multiple benefits that a well maintained Change Control program brings to a company. He will also explain when Change Control is not required to be reviewed. The point of touching upon all these areas is that the participants will be equipped with the insight needed for asking questions on issues relating to their own Change Control procedure.

Just as things change over time, not all results from laboratories, equipment qualifications and product testing will meet defined acceptance criteria, and are subject to change over time. When this happens, companies must first determine the cause, take the required corrective actions and then implement actions to prevent their recurrence.

Preventing recurrence

The effectiveness of these actions lies in how far it is able to determine the root cause. If this is not done, no action can prevent their recurrence. Kenneth will teach how to conduct such investigations and what to expect from these investigations. He will focus on the FDA Guidance document in doing this. Actual case studies will be explained to strengthen the understanding of the various topics that are covered over these two days.

Professionals who work in any of the areas of Quality System and those whose work is related to Change Control in one or another way will benefit from this session. These include Quality Assurance, Quality Control, manufacturing, production, regulatory, laboratory personnel, management and equipment vendors.

Quality by Design using Design of Experiments 2017

The Q8, which is the ICH guidance document on pharmaceutical development, requires a drug product to meet its intended product performance as well as the needs of patients. A drug product is encouraged to adapt a systematic approach for pharmaceutical development in accordance with the steps defined by Quality by Design (QbD) principles, even though the strategy may vary from company to company or from product to product.

The ICH has offered further guidance and policies for explaining the ways by which the QbD approach should be integrated into the pharmaceutical Quality System. Some of these are:

o  Process design

o  Qualification

o  Continued process verification

o  Risk management

o  Validation.

Laxity in implementation is no longer an option

Despite the issuance of guidance on implementation of these requirements; many companies have not yet implemented QbD into their Quality Systems. This will change soon, though. Regulatory agencies have been taking a serious view of non-implementation of these requirements.

The ways in which reviewers will begin to enforce the requirements from these guidance documents have been spelt out in the manual the Chemistry, Manufacturing, and Controls (CMC) reviewers in the Office of Pharmaceutical Science (OPS) released on policies and procedures (MAPP).

The zeal with which the regulatory agencies will enforce compliance with the requirements of the QbD requirements has been emphasized also by the Director of the Center for Drug Evaluation and Research (CDER) at the FDA, who detailed the concept and reiterated the importance of using a QbD approach to pharmaceutical development in a paper he co-authored in The American Association of Pharmaceutical Scientists in May 2014.

Understand the ways of implementing QbD

In the light of the fact that a drug product can no longer afford to relax in its adherence to steps defined by Quality by Design (QbD) principles to adapting a systematic approach for pharmaceutical development; a meaningful and educative two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will show the ways of doing this.

At this seminar, Heath Rushing, who is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP, will be the Director. To gain complete insight into how to implement QbD, please register for this seminar by visiting Quality by Design using Design of Experiments. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Complete learning on QbD using DoE

The core purpose of this session is to demonstrate how to integrate those QbD principles into a pharmaceutical Quality System. Towards this end, Heath will focus on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using Design of Experiments (DoE).

He will also take up the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability for detailed description. All concepts are taught within the product Quality System framework defined by requirements in regulatory guidance documents.

A systematic understanding of the process

A QbD approach for pharmaceutical development studies should include a systematic understanding of the process. It should then use this understanding to establish a control strategy as part of a comprehensive quality risk management program. This systematic understanding should include both identification of significant process parameters and determination of a functional relationship (mathematical model) linking these significant process parameters to the critical Quality Attributes (CQAs). Heath will discuss these in depth.

Despite the thrust of this seminar on the use of DoE for QbD; it will integrate multiple aspects of QbD. An understanding of the relevant applied statistics will be offered, which will help participants understand how statistics can be used to help in two foundational requirements of QbD: A) Setting specifications, and B) Analyzing measurement systems.

Important tools for facilitating understanding

This seminar will also offer tools to participants, which will help them to derive value out of their designed experiments. Generating and analyzing both screening and response surface designs for QbD studies, the ways of using this information: best practices on presentation, setting control plans, constructing control charts, and evaluating process capability are among the other constituents of this course. This course uses the point-and-click interface of JMP software for analyses.

Heath will cover the following areas at this seminar:

o  Implement QbD principles from discovery through product discontinuation

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

o  Utilize risk management tools to identify and prioritize potential Critical Process Parameters

o  Identify Critical Process Parameters and develop a functional relationship between those process parameters and your Critical-to-Quality Attributes (CQAs)

o  Establish your design space

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

o  Ensure your process is in (statistical) control and capable.

Writing and implementing effective SOP’s

Utmost thoroughness and diligence need to go into writing and implementing effective SOP’s. This is because Standard Operating Procedures are to be designed keeping the exact and fullest details of the task that is to be described. It is a very detailed art as it has to take everything into consideration and leave nothing to chance.

Even the smallest errors or discrepancies or divergences can lead to problems with the product usage. In the context of a laboratory, even with all the details that are standard; details pertaining to the exact situation of the laboratory need to be described. An SOP for even a standardized method such as ASTM or IP can be written insufficiently.

Writing is just one part of the job

If writing an SOP is one job; implementing it is another. Maintaining and assessing are yet other parts of the job. And then, there is the task of revising the SOP if needed. All these are related jobs, but are independent of each other and require different sets of people with their own qualifications and experience to handle.

The need for writing SOPs effectively is best understood in light of the fact that a poorly written and enforced one is among the most common cases of noncompliance that auditors detect.

A seminar on getting writing of SOPs right

The ways of implementing the correct means of writing SOPs for a laboratory will be taught at a seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

The seminar will have John C. Fetzer, who is Founder and Principal Consultant, Fetzpahs Consulting, as Director. John brings over 30 years of experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography and has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bio analytical Chemistry.

To gain clear understanding of how to write SOPs that are effective in both helping those working in the laboratory understand how to put it to effective use and are capable of passing compliance requirements, please enroll for this seminar by visiting Writing and implementing effective SOP’s. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Description of all the steps

At this seminar, John will describe the complex, but necessary steps both within the laboratory and within the supporting areas for implementation and revision of an SOP. Recordkeeping, safety and training are some of these steps.

John will also describe the reasons for which even standardized methods get insufficiently written. He will explain the steps needed to convert a standard method into an SOP. Laboratory workers, supervisors, managers of a laboratory seeking or under GLP or ISO 17025, and other involved in SOPs, such as Research Associates, Lab Chemists, Lab Supervisors and Quality Officers will derive high value from this seminar.

Over the two days of this seminar, John will cover the following areas:

o  What is the intention and role of SOPs? What tasks require SOPs? The network of SOPs within the Lab

o  What are the compliance requirements for an SOP? Roles and responsibilities. Can a Standard method be used as an SOP?

o  Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt

o  Creating an SOP. For a new task. For a Standard method. Reviewing the first attempt (continued)

o  Interplay within the lab to improve the draft SOP Iterations?

o  Implementation of the SOP

o  Monitoring and Assessing the SOP. When should an SOP be revised? Revising the SOP.

o  Archiving and documentation. Which SOP to use when? Other requirements.

Validation the complies with ICH guidelines

A clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures, and acceptance criteria in calibration limits is required from professionals in the field of statistical analysis. They also need to have a proper understanding of process and quality controls, as well as ICH Q8 and Q9.

The guideline the ICH has set out for analytical methods validation is the ICH tripartite-harmonized ICH Guideline on Text, which was previously coded as Q2A, finalized in October 1994 under Step 4. This guideline seeks to identify the validation parameters that are required for a number of analytical methods. The characteristics and parameters that need to be taken into consideration when validating the analytical procedures that are included in the registration applications are also laid down in this guideline.

When it comes to procedures and acceptance criteria in calibration limits, the ICH guideline is the ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B. This was finalized in November 1996 under Step 4. This guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above) to comprise the actual experimental data required, along with the statistical interpretation, for the validation of a variety of analytical procedures.

Current Step 4 for process and Quality Control

The current guideline for process and Quality Control is the Current Step 4 version of the ICH-harmonized Tripartite Guideline. The final draft of this guideline has been recommended for adoption to the regulatory bodies of the three biggest pharmaceutical markets in the world, namely the US, the EU and Japan.

Meeting critical milestones is required for professionals who want to achieve harmonization in Quality, professionals. Conducting stability studies, the way the studies define relevant limits for the testing of impurities, and following a more malleable approach to pharmaceutical quality that is based on the principles of Good Manufacturing Practice (GMP) risk management are among these milestones. ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

o  Stability

o  Analytical Validation

o  Impurities

o  Pharmacopoeias

o  Quality of Biotechnological Products

o  Specifications

o  Good Manufacturing Practice

o  Pharmaceutical Development

o  Quality Risk Management

o  Pharmaceutical Quality System

o  Development and Manufacture of Drug Substances

o  Lifecycle Management.

A thorough training session on the areas of Validation in accordance with ICH guidelines

It is important and necessary for professionals in this area to get proper guidance, considering the complexity and the breadth of the issues associated with these techniques, which cover both the pharmaceutical and clinical applications, and considering that these techniques apply to a number of area such as stability testing, outlier analysis and risk management.

A seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will offer this learning. Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama, will be the Director of this seminar. Please visit Validation the complies with ICH guidelinesto register for this valuable learning session. 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 and deep understanding of statistical concepts

Dr. Bartolucci will offer in-depth and clear learning of the statistical concepts used for investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and Quality Control, as well as with ICH Q8 and Q9.

Although not a course in statistics, this seminar will offer an applied approach to the statistical techniques used and will show how to reasonably interpret them. Participants can use this learning to address the various challenges facing pharmaceutical and biotechnology companies when they have to quantify results in a meaningful interpretable manner through tabulations and graphical presentations.

Another area of importance at this seminar is the expectations of different regulatory agencies regarding the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control. It will familiarize the participants with the critical aspects of the statistical methods and explain to them the practical application of these guidelines.

Four years of the EU’s Cosmetics Product Regulation

It has been four years since the EU’s Cosmetics Product Regulation (Regulation EC No. 1223/2009), initiated in December 2009, became operational in July 2013. This regulation was considered path breaking when it was introduced because of its comprehensive nature as well as the extent of the shift it signaled from the legislation from which it took off. It was also considered extremely significant because it suggested a regulatory framework that was in alignment with the most modern technologies and methods available during the present times.

Some of the regulatory modules which are structured into the EU’s Cosmetics Product Regulation include important elements aimed at ensuring safety of cosmetic products and accountability from manufacturers, and include points such as:

o  Cosmetic Product Safety Report (CPSR)

o  Product Information File (PIF)

o  Responsible Person (RP)

o  Label information

o  Cosmetovigilance

o  Substance regulations

o  Claims, etc.

Compliance with the safety regulations set out in EU’s Cosmetics Product Regulation is mandatory. This, though, is not easy, considering the severe clauses that the regulation has for ensuring compliance. These are the reasons for which compliance with the EU’s Cosmetics Product Regulation is challenging:

–       In-market control is assigned to EU Member State competent authorities

–       The flow of information between countries is interlinked by the Cosmetic Product Notification Portal (CPNP), which is fed with the information by the demand for pre-market notification of cosmetic products and by ongoing cosmetovigilance procedures put in place with the respective provisions in the CPR

–       The central role in cosmetovigilance applies to the Responsible Person while the access to manufacturers and responsible persons is assured by product labeling provisions

–       EU and non-EU manufactures of cosmetics as well, as the suppliers of cosmetic ingredients, are required to provide data on their chemicals

–       Compliance with the modules requires know-how, diligence and ongoing adjustment to state of the art of knowledge and documentation.

More challenges

In addition, the EU’s Cosmetics Product Regulation presents more challenges for manufacturers of cosmetic products that want to market to any of the countries of the EU:

The EU’s Cosmetics Product Regulation is so expansive that it represents not only the entry requirements for marketing of cosmetics product in the European Union; but is a model framework for many national legislations worldwide. These legislators are given the choice of either adopting a few parts of the EU’s Cosmetics Product Regulation’s modules, or the structure of the Regulation of its predecessor legislation, the Cosmetics Directive, in full. Therefore, companies need to have the knowledge and the skills needed for complying both with the EU’s Cosmetics Product Regulation and other regulatory frameworks.

There is yet another challenge to implementing the EU’s Cosmetics Product Regulation: The safety assessment. Complying with this part of the EU’s Cosmetics Product Regulation requires extensive knowledge and skill of a host of subjects and issues such as toxicology, chemistry, cosmetology and microbiology, apart from that of regulatory affairs and compliance management. This already tough provision has been made even tougher with the final implementation of the ban on animal testing that the EU introduced in March 2013,

As a result of this ban, considerable confusion abounds about the interpretation of the compliance regulations in the various agencies and sectors that the compliance process has to pass through. If alternative tests are carried out, they are not available for all toxicological endpoints that need assessment as part of the EU’s Cosmetics Product Regulation.

Clearing the confusions

This makes compliance with the EU’s Cosmetics Product Regulation as difficult and complicated as one can imagine. A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer clarity on the provisions of the EU’s Cosmetics Product Regulation. The complicated parts of the regulation, namely the regulatory modules, will be given a clearer understanding.

The Director of this two-day seminar is Dr. Annelie Struessmann, who is the Technical & Regulatory Director with CONUSBAT Regulatory Services, a provider of internationalization compliance services for Cosmetics, Personal Care, Fine Chemicals and Borderline Industries.

To gain better understanding of this regulation, please visit Four years of the EU’s Cosmetics Product Regulation to enroll. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

At this session, Dr. Struessmann will explain the provisions of the regulatory modules and supplement this with a description of the latest developments and research results. She will use these to show pathways towards compliance, at which she will use practical examples and experiences gained in the course of performing the necessary compliance steps before and while marketing of cosmetics products in the EU.