Technical training in the life sciences

It is accepted that Training and Development is a highly developed area that bring its own body of knowledge. It uses a wide variety of techniques and approaches that are designed to meet the unique and complex challenges associated with training. Training and development is a great tool for helping a professional or a lay person alike understand the tenets of their profession.

In the absence of the right professional training and development, many employees place themselves at a disadvantage vis-à-vis their colleagues. They need to keep upgrading their knowledge and skills and keep closing the gaps, so that they do not get left out in their career. Training and development also helps employees understand how they need to meet the regulatory requirements the organization is required to comply with.

Difficulties associated with training and development in the life sciences

While this is accepted, a great deal of attention is yet to be paid to the need for technical training in the area of life sciences. Applying technical Training & Development skills to the field of life sciences is very crucial, as it helps professionals in that important area take a fresh perspective of the regulations in the areas of life sciences and benefit from them.

Technical training in the life sciences applications is fraught with a few problems. This is because two important factors come into play: The activities involved in the life sciences, such as formulating Standard Operating Procedures (SOPs), work instructions, the ways of carrying out tests and clinical trials, and the exact science behind the topics in this subject are all very complex. Secondly, regulations are equally difficult to understand and implement. This however, is no excuse to skip their implementation, something that is unthinkable for this industry.

A thorough learning session on technical training for the life sciences

It is to help professionals in the life sciences become more familiar with training and development, and to ease the complexity of their training needs that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar.

Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm that is celebrating its twentieth year of existence in 2017, will be the Director. To understand the importance of technical trainings for the life sciences and to get to know how to implement legally compliant life sciences training programs for your organization, please enroll for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900920SEMINAR?wordpress-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.

Arousing the interest in training for the life sciences

The purpose of this seminar is to help kick start the training and learning needs of talented and technically competent training professionals who may need more focused instruction and direction in the area of technical training in the Life Sciences. Charles will offer guidance to all training professionals at all skill levels in how to truly build and sustain a training organization in today’s difficult corporate environment, and how to effectively identify gaps in workforce training and compliance documentation and build effective and inexpensive training materials with the tools that are available.

A very important benefit participants of this seminar will take away from here is that they will learn how to integrate Training & Development with compliance, so that they can leverage the benefits of compliance to improve the performance of the workforce and the overall performance of technical operations.

Important personnel in the life sciences industries that are associated with training, such as Directors of Training, Training Supervisors, Training Coordinators, Training Developers, Instructional Designers and Instructors will derive high benefits from this seminar. Over the two days, Charles will cover the following:

o  Introduction to Training and Development in the Life Sciences and the Relationship between Training and Regulatory Compliance

o  Training and Development Basics

o  The Building Blocks of Human Performance

o  Building a Training and Development Organization – Leverage what you have and Negotiate for What You Don’t

o  Perform a Documentation and Training Analysis – Discover the Gaps

o  Training Materials – SOPs and Work Instructions as Training Materials – It’s not as easy as you think! Leverage the Opportunity!

o  Working with Subject Matter Experts and Outside Consultants

o  Case Study Review and Discussion – This Approach Works!

Unravelling the DHF, Technical File and Design Dossier

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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.

 

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Outstanding characteristics of the Design History File

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What should the Design History File contain?

The DHF should contain the following:

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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

 

 

Adherence to GMP is absolutely essential for Quality Control and Contract Laboratories

It is absolutely essential for contract laboratories to maintain the required standards of Quality Control because of the risk their process involves: After testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check.

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This fact is the primary reason for which regulatory agencies such as the FDA, EMA and many others place the highest emphasis and priority on inspections of QC laboratories. This is also one of the main reasons for which a huge number of QC related 483’s and Warning Letters get issued to companies that have problems with their implementation, despite the existence of cGMP regulations for a long time.

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Helping to understand and imbibe GMP

A complete understanding of GMP for Quality Control and contact laboratories will be offered at a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing. Dr. Ludwig Huber, Chief Advisor – Global FDA compliance at Agilent Technologies, will be the Director at this seminar.

To gain the benefit of this learning, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900698SEMINAR. 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 regulatory background and guidelines

At this highly interactive two-day seminar, Dr. Huber will offer to participants the regulatory background and guidelines needed for all critical areas of GMP compliance. He will update them with the latest requirements of this compliance document, which will help them understand and implement these.

As a result of the learning gained at this two-day course, participants will be able to:

  • Learn about the regulatory background and GMP requirements for quality control and contract laboratories
  • Understand and be able to explain their company’s quality plan or laboratory compliance master plan
  • Understand the difference between GMP and non-GMP laboratories
  • Learn how to develop inspection ready documentation
  • Be able to train others in their organization on GMP requirements
  • Learn how to avoid and/or respond to the FDA inspectional observations and Warning Letters.

A practical session

In addition, the Director will also be providing participants with templates and examples with which they can develop inspection-ready documentation. Another of the highlights of this session is that practical examples and interactive exercises will be sprinkled into and between the presentations, with half of the duration of the seminar being dedicated for practical sessions.

Taking the interactive element a step further, Dr. Huber will arrange participants into small groups for the purpose of discussing case studies and prepare the answers using prepared fill-in templates. Yet another bonus of this session is that after the course, Dr. Huber will make a large variety of tools such as SOPs, validation examples and checklists readily available on a dedicated website so that those who have attended this seminar can use them to easily implement what they have learned from the course.

A complete understanding of the payroll law

Those who are responsible for payroll or employer tax withholding compliance or have just been hired or promoted into the payroll department would have discovered during their indoctrination just how important this role is to the success of the organization.

Their learning is a continuous process that goes on and on. Employees in this position need to build a solid foundation for handling their company’s payroll obligations and complying with federal and state payroll laws. They need to be familiar with how to find the authoritative laws to support their policies and procedures.

Clear and comprehensive learning

A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will help participants achieve this. Miles Hutchinson, who is President, Sales Tax Advisors, Inc., and is a CGMA and experienced businessman, who brings over 35 years in the field, will be the Director of this seminar. To gain the benefit of learning from this expert, please register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900485SEMINAR.

Equipping participants with the law in all its depth

This organized and thoughtful learning session will help participants accelerate their learning and understand how to handle their role with confidence. Miles will help participants who are concerned about their company’s ability to comply with U.S. labor and payroll laws with a formal study of the rules of engagement. This will help ensure that their company pays their employees fairly and handles tax and other withholdings appropriately, as mandated by law.

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Miles will show where to find the laws, how to interpret them and how to apply them in the most effective ways. The objective of this learning is to equip its participants with the skill and knowledge needed to master the laws and identify the best practices to keep their organization in compliance and out of court. Implementing this saves them huge sums of money in fines and legal.

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A very broad range of topics will be covered at this seminar. These include:

  • Worker classification
  • Employee classification
  • Ways of establishing methods and rates of pay
  • What must be included in the rate of pay
  • Hours that must be compensated as worked time
  • Required benefits
  • De minimus working fringes
  • Withholdings and deductions from pay
  • Voluntary deductions
  • Child support and garnishment orders
  • Payroll reporting
  • Analysis of risks of noncompliance
  • Proper documentation of the policies and procedures and record retention requirements.

Globalcompliancepanel Successfully Completed Seminar in Los Angeles -New FDA FSMA Rules

New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

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Globalcompliancepanel Successfully Completed Seminar in Philadelphia-Design of Experiments and Statistical Process

Design of Experiments and Statistical Process Control for Process Development and Validation

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Identifying and managing key risks is the primary purpose of HR auditing

Human resources audit should qualify as the most important of all audits of an organization. This is because HR auditing is directly related to employees. This resource, the organization’s human capital, is the organization’s most important resource. It is through an HR audit that an organization evaluates this resource’s strengths and weaknesses.

HR audits help organizations in a number of ways

HR auditing helps organizations achieve this in many ways. Through HR audits, organizations are able to eliminate human capital risks, which will lead them to core actions such as ascertaining potential and actual problem areas, assessing the effectiveness of current HR management activities, measuring the weaknesses in HR internal control processes, evaluating human capital strategic and compliance related risks, and suggesting corrective action on all these.

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Getting the HR auditing right

Getting its HR audit right is the foundation to all these for an organization. The ways by which this can be achieved will be the subject of a two-day seminar that GlobalCompliancePanel, a renowned provider of professional trainings in the regulatory compliance areas, will be organizing. You can register for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900675SEMINAR.

The Director at this seminar, Ronald Adler, who is President of Laurdan associates, Inc., will offer insights, accumulated over four decades in the industry, into HR auditing.

The basis of effective HR auditing lies in asking the right questions

Ronald Adler will emphasize the point that the root to carrying out HR audits effectively is in asking the right questions. The effectiveness of HR audits is measured by how they throw up a structured and systematic series of questions about the areas relating to key compliance, risk management, internal auditing, and human resource management issues in HR, which are the main purpose of these audits.

The role of ERM in HR audits

Another important point that Ronald Adler will highlight at this seminar is the importance of HR audits in considering human capital-related risks and opportunities from an Enterprise Risk Management (ERM) perspective. This means that the HR audit should take a holistic view of human capital risks and align the interrelationships and interactions between HR and other functions relating to management and the organization.

Yet another aspect that will be reviewed is the current use of HR audits. Adler will explain how HR Audits can be used to help the organization reduce risks and grab potential opportunities. All key personnel involved in human capital assessment, such as HR Professionals, CFO’s, Internal Auditors, External Auditors, Risk Managers, Compliance Officers, and COO’s, will benefit vastly from this seminar.