The webinar focuses on effective implementation of QRM through the understanding of the ICH Q9 process and principles of QRM. By reviewing the standard terminology of risk management and laying the foundation for a more practical approach to applying the QRM principles of ICH Q9 to any biopharmaceutical manufacturing process and equipment, it enables you to speak the same "language of risk" as those of the regulators and thereby significantly reduces your companies exposure to audit failures.

Risk management activities involve processes, methods, and tools for identifying, assessing and managing risks. These activities are conducted in a disciplined environment. It requires proactive decisions to continuously assess what could go wrong during the manufacturing of any product. This webinar addresses how to identify the critical risks and mitigate them. It provides a systemic prospective of QRM using the Swiss cheese model. Specifically, it focuses on key factors for a successful Risk Management process, the 7 key concepts in FDA's systems approach thinking to Risk Management, the required QRM documents and their contents and Risk Assessment methods and tools.

The webinar aims to equip and empower attendees with the knowledge of basic risk management terminology, the deployment of appropriate tools for risk assessment, FDA's audit care about for QRM , as well as how to apply risk management principles to various aspects of a quality system. Among the topics to be discussed are the key steps in the identification of risks, establishing a scoring criteria to analyze identified risks, use of the 5-p model for risk reduction, risk acceptance basics including factors that establish a risk acceptability criteria, elements of a Risk Control strategy and what and when to communicate with risk stakeholders. Since Risk Management is a dynamic process, topics will also include how to continuously monitor risks and integrate them into a continual improvement strategy, along with the management's role of ensuring the adherence to the strategy.

Why you should attend: ICH Q8, Q9 and Q10 have been the bedrock of the regulatory agencies' regulations for pharmaceutical cGMPs for the 21st century. While adoption of these has been slow, some like Q9 and Q10 are increasingly coming into acceptance by the industry. Adoption of concepts such as Q8's QbD have been slow because it is still in its infancy and will require more time if it is to have the transformative effect first conceived by ICH. However, QRM (Q9) and Quality Systems (Q10) are increasingly coming into acceptance by the industry since their understanding is not as intricate and complex as QbD is. It is becoming increasingly evident that application of QRM (Q9) techniques would provide the refinement tools to formulate and validate the QbD (Q8) models of the processes. Hence a good understanding and application of QRM techniques and tools would be instrumental in the development of realistic QbD models that are more reflective of true process characterization and actual process behavior.

The approach to quality and risk management is dynamic in nature due to the evolution of science and technology. This dynamic nature imposes a challenging situation for companies since they are now required to keep themselves fully trained and informed of the changing regulations. Additionally, with the increasing formalization of QRM tools and techniques, regulatory agencies are requiring companies to establish Quality Risk Management Plans that are being used as starting points for their audits. The requirement for performing QRM coupled with QRM's dynamic nature increases companies' risk of audit failures. Citations arising from such audit failures are being addressed through a consistent documentable approach to risk management throughout the company irrespective of the business and manufacturing processes. This webinar addresses the "common language of risk" coupled with the documentation strategy required to maintain a defensible risk control strategy to meet compliance requirements.

Areas Covered in the Session:
Characteristics, history & FDA’s involvement with QRM
In perspective: QbD, QRM and Quality systems
ICH Q9 Process
Principles of QRM
Key elements of QRM
Characteristics of QRM
Systemic processes and General Failure Types
7 Key concepts in FDA systems approach thinking
Swiss cheese model for systemic related safety
QRM documentation and their contents
Factors for a successful Risk Management process
Hazard, Harm, Risk concept
Key steps in risk identification
Use of scoring criteria and Heat Maps in analyzing and evaluating risks
Risk reduction and Risk acceptance basics
Factors that establish a Risk Acceptability criteria
QRM tools used; their strengths and limitations
Selection of appropriate tools for different circumstances
Who Will Benefit:
Project Managers, Lead Engineers, Software Engineers
Risk Managers and others Performing Risk Management Activities
Those involved in process improvement
Contractor, Consultants Providing Engineering and Validation Services
QA, Regulatory Affairs, Engineering & IT personnel

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

Overview: This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan.

This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities. We will discuss both laboratory instruments and critical facility systems. We will provide templates for risk assessment and validation strategy. A case study will illustrate the time lines, cost savings and benefits of a risk-based validation master plan.

In installing equipment, how much validation is enough? How much is too much? Risk-Based Validation establishes rules for what is appropriate and is the FDA-preferred method for determining what qualification protocols are required. It is based on the intended use of the equipment and the impact it may have on regulated processes, safety and quality. This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan. It includes a specific real-life project involving over 100 separate pieces of equipment and utilities, and the regulatory inspector’s subsequent comments.

Areas Covered In the Session:

Risk-Based Equipment Validation
Equipment and Utility Qualification
Risk management Tools
Functional Risk Analysis
Risk Scoring
Risk Mitigation
Score-Based Validation
Project Outcomes

Who will benefit: This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and manufacturing services will also benefit.

End-users responsible for applications and systems
QA Managers and Personnel
Facility Managers and Personnel
Senior Quality, Regulatory and Operations Management
Regulatory Affairs staff
Quality System Auditors

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.

It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

Why you should attend: Increasingly U.S. companies are going global and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/B9DD. Being aware of the similarities and differences can further concurrent development and/or updates to both

Areas Covered In the Session:

* The U.S. FDA's DHF
* The EU's MDD and the Technical File / Design Dossier
* Design Control vs. a Product 'Snapshot in Time'
* DHF "Typical" Contents
* TF / DD Expected Contents
* Parallel Approaches to Documentation -- Teams
* Future Directions
* FDA and NB Audit Focus

Who will benefit:

* Senior management in Drugs, Devices, Biologics, Dietary Supplements
* QA
* RA
* R&D
* Engineering
* Production
* Operations
* Marketing

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Overview: Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s and expanded as an international expectation for the industry with the publication of ICH Q2 in the mid 1990s.

Both USP <1225> and ICH Q2 classify test methods employed in the industry into types, based on the intended use and identify the characteristics that must be considered in the validation of each type of method.

In order to perform effective test method validations, the analyst must understand the importance of clearly identifying and understanding the intended use of the test method. With the understanding of the intended use, the analyst will categorize the test method into one of the types identified in the USP and ICH Q2. Based on the type of test method and using the guidance in the USP and ICH Q2 the analyst will identify the characteristics that must be considered for effective method validation.

For each characteristic, the USP and ICH Q2 recommend the experiments that the analyst should performed to demonstrate that the method performs as intended.

Why you should attend: The US FDA and other regulatory agencies are critically reviewing test method validations. Observations like: "Failure to establish accuracy, sensitivity, specificity, and reproducibility of test methods employed by your firm", which appear in Warning Letters and 483 observations demonstrate a complete lack of understanding of the regulatory expectations. Other observations that citing to the individual characteristics demonstrate a lack of appreciation for the contributions of the individual method characteristics on adequate method validations. In order to adequately validate test methods, firms must understand the basic terminology associated with test method validation. This webinar will provide an understanding of:

The types of test methods established by the USP and ICH Q2.
Assay
Identification
Testing for impurities – quantitative
Testing for impurities – limit
Performance
The characteristics of test methods as defined in the USP and ICH Q2.
Specificity
Accuracy
Precision
Linearity
Range
Limit of Accuracy
Limit of Detection
How the characteristics apply to the types of methods described in USP and ICH Q2.
The basics of how to experimentally evaluate the characteristics.

Areas Covered in the Session:

The requirement for test method validation
The intended use of the test method
Guidance documents covering test method validation
Types of test methods
Characteristics of test methods
Demonstrating the characteristics

Who will benefit: The following individuals or disciplines will benefit from attending this Webinar:

Quality Assurance personnel
Quality Control Managers
Quality Control Supervisors
Quality Control Analysts
Method development Managers
Method development Supervisors
Method Development Analysts

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Overview: FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned. This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements.

Areas Covered in the Session:

* Discussion of the elements found in the guidance document for Phase 1 material.
* What to do at really early stages.
* What about special IND studies?
* What about preclinical studies?
* Varying GMP activities that depend upon the nature of the IND product.
* What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
* What to do about QC activities such as instrument qualification, method validation, and process validation.

Who Will Benefit: This presentation will be aimed at helping Regulatory, Quality Assurance and Quality Control personnel to understand the varying types of GMP activities that accompany early stages of Product development.

* Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions.
* QA/QC personnel who need to plan work on early stage material
* R & D personnel who will contribute data to CMC sections.
* Project managers for product development studies.
* Quality systems auditors
* Consultants

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Overview: If you handle any electronic patient information, don’t miss this teleconference on compliance with the extensive requirements for policies and procedures in the HIPAA security regulation.

Electronic patient information is everywhere; not only is electronic protected health information in the obvious places such as practice management systems and electronic medical records, but also in less obvious places such as copiers, printers, scanners, cell phones, and portable data devices. All entities covered under HIPAA must take special care of electronic patient health information, including establishing policies and procedures to protect all kinds of PHI and taking regular actions as part of a security management process.

Proposed changes and expansions to HIPAA, going into effect in 2011, dramatically expand the types of entities to which the regulations directly apply, which means that more entities than ever need to adopt the proper HIPAA Security policies and procedures to be in compliance.

HHS compliance audit activity and enforcement penalties are both increased, especially in instances of willful neglect of compliance, if, for instance, your organization hasn't adopted the complete suite of information security policies and procedures needed for compliance.

Learn what it takes to get in compliance and stay there, even as your operations and environment change. Find out what administrative, physical and technical safeguards are necessary and what policies they call for, and how you decide what’s right for HIPAA security compliance for your organization. This teleconference will provide the background and details necessary to develop an understanding of the origins of the HIPAA security regulation and the process used in complying with the rule, which leads, inevitably, to the adoption of policies and procedures.

With the expansion of electronic devices and systems in use for health care, remote access and use of data now require special attention to secure protected health information, and special policies and procedures as well, especially now that portable devices are a leading cause of information security breaches.

If you are asked by the US Department of Health and Human Services to show that you are in compliance with the HIPAA security regulation, you will need to show that you have the proper policies and procedures in place as required by the rules and that you have been using them. This teleconference will lay out a structure for the set of policies needed and identify the topic areas that policies should include, making it easier to deal with the dozens of policy details that are required.

Areas Covered in the Session:

* Find out what are the requirements for policies and procedures and why they're a good thing.
* Learn how having good policies and procedures and good documentation can make compliance easier.
* Learn the set of policies that need to be included in four groups of policies: Information Security Management Process, Acces Controls, Data Management, and the Information System User Policy.
* Learn how to use your policies and procedures, and the documentation of use of your policies and procedures, to satisfy audit requirements and avoid penalties.
* Find out about scaling your policies to fit your organization - one size does not fit all!
* Learn with the significant penalties are for non-compliance with policy and procedure requirements.
* Find out what are the first steps to take in developing your polciies and procedures for HIPAA Security compliance.

Who Will Benefit:

* Compliance director
* CEO
* CFO
* Privacy Officer
* Security Officer
* Information Systems Manager
* HIPAA Officer
* Chief Information Officer
* Health Information Manager
* Healthcare Counsel/lawyer
* Office Manager
* Contracts Manager

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Overview: In this session, attendees will learn what the PCI DSS requires for protection and how the PCI DSS relates to the HIPAA Security Rule - there are substantial similarities, and being prepared for one helps you prepare for the other, as well as for other requirements, such as breach notification. We will discuss how the regulations and standards work and their legal basis, as well as provide up-to-date information on any expected changes.

Attendees will learn what information is covered under the HIPAA and PCI rules and what are the ways the information should be protected, including the safeguards called for by HIPAA and PCI. They will learn what are the consequences of not protecting health and payment information and what to do if their information security is compromised. We'll talk about strategies to limit exposures under PCI and HIPAA, and what steps can be taken to help limit the scope of compliance for PCI by keeping payment card information off of your office networks. Attendees will find out what they can do to minimize the payment card information they keep, restrict where it goes and who in their organization needs it, and minimize their obligations under the standard.

Meeting any set of information security requirements always involves conducting a thorough risk analysis to make sure you haven't overlooked any weaknesses. We'll discuss what's involved and how it is the cornerstone of your compliance efforts.

Attendees will learn the way to devise policies and procedures that can work to meet multiple regulatory requirements and will learn the role of documentation in showing compliance and assisting in the information security management process. Having good policies provide the foundation of good practices and compliance - we will discuss a set of topics that should be covered in a good set of information security policies meeting HIPAA and PCI requirements.

Areas Covered in the Session:

* Health and payment information must be kept securely - learn what is required and what is a good way to attain compliance with multiple regulations
* HIPAA and PCI have many similarities, but some important differences as well. Keeping your information well controlled can help with both.
* Find out about how you can discover where payment card information is and is not needed, and how to keep it to a minimum so you can limit your exposure to the PCI requirements
* Do you know what to do if your information security is breached? Learn who needs to be notified and why.
* Learn about the latest changes and updates to the PCI Data Security Standard and how they impact you
* Find out how to create useful and effective security policies and how to document compliance with them.
* Learn what are the first steps to take in attaining compliance with these increasingly important requirements.

Who Will Benefit:

* Compliance director
* CEO
* CFO
* Privacy Officer
* Security Officer
* Information Systems Manager
* HIPAA Officer
* Chief Information Officer
* Health Information Manager
* Healthcare Counsel/lawyer
* Office Manager
* Contracts Manager

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Overview: This session will present the background of the regulations that call for information security risk analysis and show how it fits in to an overall information security management process. The risk analysis process will be presented within the context of the overall risk prioritization and risk mitigation process, using an example.

The Information Security Risk Analysis Process presented utilizes a non-technical approach, involving interviewing staff knowledgeable about operations and systems to discover how information is retained and moved, and reveal the risks inherent in such storage and transmission. Interview content is organized as departmental stories that are successively refined into process descriptions, lists of information in place or in motion, diagrams of information flows, and lists of information systems and flows to be assessed for risks. Risk issues and recommendations for each system or information flow can then be described and organized into a table that is used to define the risks and prioritize their mitigation, using a straightforward high-medium-low stratification of potential likelihood and impact for each risk issue, following the risk determination method identified in the preamble to the HIPAA Security Rule and guidance from the US Department of Health and Human Services. Areas of high risk, as identified by respected industry organizations, will be identified to ensure that the most significant risks are discovered and adequately prioritized.

The risk analysis process will be applied to a simplified example in order to relate the process to a real situation and drive home the usefulness of the process.

Areas Covered in the Session:

* Learn how to conduct an information security risk analysis suitable to aid in compliance with the HIPAA Security Rule and other information security regulations relevant to health information managers.
* Find out what the rules are that health care providers must follow, why they are important, and what the penalties are for not complying, including the new penalties for willful neglect of compliance, which begin at $10,000.
* See how the risk analysis requirement for meeting the privacy and security objective of meaningful use, necessary for federal funding, fits in with HIPAA compliance.
* Learn what steps to follow in the discovery and organization of information needed for the risk analysis.
* Find out what are the most significant risks a health care organization faces and how they can be mitigated.
* Learn a methodology for working through the risk analysis information to discover security strengths and weaknesses and develop a list of priorities for improving security compliance.
* Discover that staff need not be technicians in order to perform a useful risk analysis.
* Discover that a risk analysis can be useful for guiding decision-making for appropriate policies and procedures, and security investments.

Who Will Benefit:

* Compliance director
* CEO
* CFO
* Privacy Officer
* Security Officer
* Information Systems Manager
* HIPAA Officer
* Chief Information Officer
* Health Information Manager
* Healthcare Counsel/lawyer
* Office Manager
* Contracts Manager

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Overview: This webinar will provide an overview of process validation for devices and pharmaceuticals.

While most of the webinar will include FDA compliance requirements, there will be some International Standards Organization (ISO), European, and Canadian regulations included for exploration. After attending this webinar, attendees will have a greater perspective of process validation and its application to all medical products. They will better understand the importance of their role not only in maintaining the process but also in helping diagnosis and treatment of patients more consistent.

Why Should You Attend: Process Validation (PV) has been a widely discussed and debated "phenomenon" in FDA regulated industries for many years. Do you know what process validation is and how you would explain it to an "alien" from another industry? Now, this is not to mean that other industries do not practice process validation because they do. It is that in the manufacture of medical products, so much is at stake for the professional and their patient. It is imperative that medical products must perform consistently so that patients can be treated in a predictable manner to treat, cure, and diagnose disease.

Areas Covered in the Session:

* Defining IQ/OQ and validation and its role in maintaining product quality
* Roles and responsibilities in the validation process
* The process validation lifecycle from design to product discontinuation
* How about Process Analytical Technology (PAT)
* Similarities and Differences-Product and Process Design
* Similarities and Differences-Equipment and Facilities
* Similarities and Differences-Supplier and Component Consistency
* Protocol Approval Process for Installation & Operational Qualification and Process Validation
* Executing the Protocols
* Reviewing the Issue Protocols, Taking Appropriate Actions, and Writing the Report
* Revalidation

Who Will Benefit:

* Quality, quality control, regulatory, engineering, and manufacturing and IT staff working in the FDA regulated industry in the development and manufacture of medical products.
* Interdepartmental functions associated with scaling up and commercializing a new medical product
* Regulatory Affairs
* Companies manufacturing combination products
* Suppliers and software vendors, servicing the FDA regulated industries, who want to better understand the customer’s needs and requirements.

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Overview: Auditing an API CMO or any API supplier is a specialty that requires knowledge and experience that is gained through exposure to the unique attributes associated with API manufacturing.

API manufacturing has similar regulatory GMP expectations as drug products, but not identical in is specific requirements and application. The nature of API manufacturing and its usual purification processes all influence how an API process should operate. Knowing what the FDA expects and how these regulators apply API GMP is important to API purchasers and drug product firms. Reducing risk and protecting the quality of a Drug Product (DP) is critical to the DP firm's success. The webinar will focus on the Q7 and FDA GMP requirements, what are the key contractual requirements and what should be negotiated and documented within quality agreements with a CMO firm.

Why Should You Attend: Attending this webinar will help you identify what you need to know and examine during an audit of your CMO or API suppliers. The webinar leader will help you identify key regulatory and industrial issues associated with API manufacturing. You are purchasing more than a chemical or biological material. You are purchasing a material that can carry with it hidden risks if not properly examined and controlled. Such examination is not always productive if you rely simply on testing protocols. You need to learn where to look and what to focus on during any on-site audit. While understanding the applicable GMP is important, how to apply the GMP and what to establish with a CMO is critical to your supply chain.

Areas Covered in the Session:

* Examine key elements of an API audit
* Audit preparation
* The audit itself
o Opening Session
o Audit itself
o What to look for?
o Discussion of findings
o Suggestions and experience
* Closing Meeting
* Who should participate in audit
* Who should attend openning and closing sessions
* Audit Reports
* Follow-up Actions
* Agreed upon Schedules
* Follow-up Audits

Who Will Benefit:

* Supervisors and Managers in Manufacturing
* Supervisors and Managers in Quality
* Engineering
* Maintenance Supervisors and Managers
* Warehousing and Materials Management Supervisors and Managers

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00