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Instructor : Dr. Ludwig Huber
Product Id : 30383PACK

Overview: High Performance Liquid Chromatography is the most frequently used analytical tool for pharmaceutical and API testing laboratories. FDA and international agencies require HPLC equipment to be calibrated, qualified and tested to ensure accurate and reliable analytical results. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis.

The main challenge is to do the right testing in the right sequence. Attendees will learn how to develop qualification and test protocols from planning and setting specifications through installation, operational qualification to performance testing and reporting. .

For Easy Implementation, Attendees Will Receive:
  • SOP: Qualification of High Performance Liquid Chromatographs
  • SOP: Testing of High Performance Liquid Chromatographs

Areas Covered in the Session:
  • FDA and equivalent international requirements
  • Examples for recent 483s and Warning Letters
  • HPLC qualification according to USP <1058>
  • Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
  • Selecting parameters and acceptance limits for HPLC initial and on-going testing
  • Recommended test sequence for highest efficiency
  • Approach for existing systems
  • Approach for automated systems (incl. firmware/computer systems)
  • Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
  • Documentation requirements.

Who Will Benefit:
  • Laboratory managers and staff
  • Analysts in quality control laboratories
  • QA managers and personnel
  • Regulatory affairs
  • Training departments
  • Documentation department

Instructor : Anna Longwell
Product Id : 30383PACK

Overview: This presentation will describe the developing area of Health Care Software regulation in the US. It will explain the role of FDA, ONC (Office of the National Coordinator for Health Information Technology), and for wireless apps, the FCC. It will also describe expectations for software that is a device component, as well as standalone software that is a regulated medical device

Why should you Attend: Inadequate validation of software continues to be a leading component of device warning letters. Problems mainly include 1) Software that is a component of the manufacturing process (not necessarily a medical device, but like all device class II and III, manufacturing elements, subject to QSR’s), or 2) software that is a component or accessory of some Class III or Class II medical device (Itself a medical device, per FDA guidance).

Also, with the proliferation of numerous applications in the Health Care, some developers are still unsure whether or not their product is a medical device. Finally, even though some applications can meet the definition of a medical device, Guidance indicates that FDA is not going to regulate them. Can you tell which is which?

Areas Covered in the Session:
  • Who regulates software and why
  • How to tell if the software you are developing is a medical device
  • What does “enforcement discretion” mean and how does it apply to software
  • What are the expectations for software that’s an integral part of a device
  • What about software that is offered to analyze signal from a medical device, but is not a part of the device, has a different manufacturer and seller? (e.g., sequencer raw data from manufacturer A, can be analyzed by software from either software seller B or C, and translated using different interfaces from either B or C to the local LIMS
  • What about software used in the manufacturing process but not sold
  • Who is enforcing HIPAA, Patient privacy, for device software?
  • And what does Part 11 have to do with my software?

Who Will Benefit:
  • Code Developers working on Edical Applications
  • Regulatory Affairs Associates
  • Health Care Software Marketing Associates
  • QA associates for firms that are developing/revising Medical Software

Anna Longwellis currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Prior to establishing the firm, Ms. Longwell was VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billion/annum unit of BD engaged in global manufacture and sale of medical devices, consumer products and OTC drugs. In that context, she participated as regulatory expert in many pre-acquisition due diligence teams. Prior work experience included a division of BD investigating monoclonal antibodies as therapy, and Alza Corporation during the period when they pioneered combination products. She has been a visiting lecturer in food and drug law at the University of Santa Clara school of law, a visiting lecturer in food law at the Institute of Agribusiness, University of Santa Clara School of Business, a visiting lecturer in regulatory topics at the Haas School of Business, UC Berkeley, and the UC Santa Cruz Extension (UCSC), and an instructor for the Food and Drug Law Institute (FDLI) internship program at Catholic University, Washington DC. Currently, she is co-teaching a class in US Medical Device Regulation, winter quarters at UCSC. Ms. Longwell has coauthored a book chapter titled “Due Diligence Points to Consider” in the “Expert’s Guide to Healthcare Product Due Diligence” published by FDLI.

Ms. Longwell holds a bachelor’s degree in Chemistry from San Francisco College for Women (now USF), a Master’s degree in Physical Science from Stanford University, and a JD and MBA from The University of Santa Clara School of Law and School of Business, respectively. She is a current member of the California Bar (#166040) and the US Patent bar (#50629).

Instructor : Dr. Ludwig Huber
Product Id : 30383PACK

Overview: Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine.

In addition FDA, USP and international agencies promote the QbD approach because it is expected that such performance based routine methods can be changed within the analytical target profile (ATP) without regulatory resubmission and approval. This seminar will give a good understanding of QbD for analytical methods and provide recommendations for implementation. .

For Easy Implementation, Attendees Will Receive:
  • SOP: Development and Validation of Analytical Methods through Quality by Design
  • Master plan - Template and examples: Development and Validation of Analytical Methods through QbD

Areas Covered in the Session:
  • General principles and key benefits of QbD
  • Regulatory background and trends: FDA, ICH Q8/9/10
  • The Application of QbD for analytical methods
  • Reasons for changing the way we validate methods
  • Comparison of the QbD process with ICH Q2 and USP <1225>
  • Benefits for method transfer and routine use
  • Using the lifecycle approach for method design, development and validation
  • Defining the Analytical Target Profile (ATP) and design space
  • Using the risk assessment prioritization matrix to select the test parameters
  • Multivariate experimental design to select the parameter range
  • The timeline for method design, validation and verification
  • Using the method in the routine: review, revalidation and change control
  • Recommendations for implementation

Who Will Benefit:
  • Method development groups
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Documentation department
  • Consultants

Instructor : Michael Brodsky
Product Id : 30383PACK

Overview: Many laboratories regard Quality Assurance, Quality Assessment and Quality Control as independent activities, others use the terms interchangeably, e.g. QA/QC. This demonstrates a lack of appreciation of the differences between Assurance, Assessment and Control, as well as the interrelationships, particularly between QA and QC. This has created confusion in the minds of many analysts with respect to understanding how QA and QC play separate, but related roles for achieving Quality Assurance in a Quality Management System (QMS). QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005.

Accreditation to international standards is being becoming the norm in the global analytical community. Although essentially voluntary, there are many jurisdictions that now require food and environmental laboratories to be accredited to ISO/IEC 17025 in order to participate in regulatory programs. This webinar will address not only how to develop a QMS that will affect the day to day operation of the laboratory, but also how to maintain it.

Why should you Attend: Many laboratories struggle with developing and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Once accreditation has been achieved many laboratories have difficulty maintaining the QMS as evidenced by the number of non-conformances cited during the subsequent biannual audits. Why do you want to become accredited? Where do you start? For laboratories that are already accredited, how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits? Getting there is relatively easy. Staying there is hard part.

Areas Covered in the Session:
  • Defining a Quality Management System (QMS)
  • Management Components of a QMS
  • Technical Components of a QMS
  • Method Selection, Validation and Verification
  • Ensuring analytical competency
  • Ensuring analyst competency

Who Will Benefit:
  • Laboratory Management/Supervision
  • Laboratory Quality Development
  • Laboratory Quality Management
  • Laboratory Quality Control
  • Analytical support

Instructor : Dan OLeary
Product Id : 30383PACK

Overview: The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".

The presentation illustrates the statistical concepts. The Global Harmonization Guidance document on process validation shows the application of statistical techniques. In particular, the guidance explains the use of design experiments (DOE) to establish process parameters and develop challenge points for the Operational Qualification (OQ) phase. The guidance explains the concepts of process capability showing the relationship between the process statistical characterization and the engineering specification transferred from design. Statistical Process Control (SPC) is an important technique in the Performance Qualification (PQ) phase of validation.

The presentation concludes by showing the strong relationship between validated processes and Risk Management. ISO 14971:2007 requires that production (and post-production) information go back to Risk Assessment to help complete the life cycle. Validated processes, where the manufacturer cannot fully verify the output, present a risk of product "escape". Statistical information of each lot from a validated process should be part of the Risk Management File.

Why You Should Attend:
If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material. This is the essence of the statistical approach.

This webinar presents the statistical approach that will help you validate your processes. Your team should attend this webinar if you cannot easily answer these questions.
  • Can you give the statistical rational for you verification sampling plans?
  • Can you state the desired and actual process capability you need to achieve?
  • Can you list the worst-case input parameter combination for your process?
  • Do you know how to determine challenge points for your process?
  • Have you set action limits for your process inputs?

Areas Covered In the Seminar:
  • QMS Requirements for Process Validation
    • FDA’s QSR (21 CFR §820.75)
    • ISO 13485:2003
  • The Statistical Process Model
    • Relating input to output
  • The Process Output
    • Sampling Inspection
    • Process Capability
  • The Process Input Parameters
    • Design of Experiments
    • The Challenge Points
  • Risk Management
    • Production Information
    • Validated Processes as High Risk

Who will benefit: People in the following roles can especially benefit from the knowledge in this webinar:
  • Quality Managers
  • Quality Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners

Instructor : John N. Zorich
Product Id : 30383PACK

Overview: The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias.

The webinar ends with an explanation of how to combine all relevant uncertainty information into an "Uncertainty Budget" that helps determine the appropriate width of QC specification intervals (i.e., "guard-banded specifications"). Spreadsheets are used to demonstrate how to perform the methods described during the webinar.

Why should you attend: All manufacturing and development companies perform testing and/or inspection that involves measurements of products, components, and/or raw materials. The output of those measurements is compared to design or QC specifications, to determine whether or not the measurements "pass" those specifications.

However, all measurement processes have some inherent variability; that is, a given measurement will likely not be exactly equal to the true value, because of variation from a number of different sources. Some of those sources are: person to person, equipment to equipment, time to time, and calibration to calibration. How much trust to place in a given measurement can be quantified by determining the magnitude of each of those sources; in effect, the larger the uncertainty of the measurement (i.e., the greater the measurement variation, in comparison to the size of the design or QC specification interval), the lower the trust that should be placed in a given measurement. If the measurement uncertainty can be quantified, it can be applied to reduce the width of the design/QC specifications, so that the resulting "guard banded" specifications can be used without concern for measurement variation.

Areas Covered in the Session:
  • Fundamental Vocabulary & Concepts
  • Gage R&R (ANOVA method)
  • Gage Correlation
  • Gage Linearity
  • Gage Bias
  • Uncertainty Budgets and Guard-banded Specifications

Who Will Benefit:
  • QA/QC Supervisor
  • Process Engineer
  • Manufacturing Engineer
  • QC/QC Technician
  • Manufacturing Technician
  • R&D Engineer

Instructor : Jeff Kasoff
Product Id : 30383PACK

Overview: Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Areas Covered in the Session:
  • How to prepare for an FDA inspection
  • Development and contents of an SOP for FDA inspection
  • Personnel training before inspection
  • How to behave during an inspection
  • Limitations of scope of inspection
  • Response to investigation findings
  • FDA guidance documents used by their inspectors

Who Will Benefit: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
  • Executive/senior management
  • Regulatory management
  • QA management
  • Any personnel who may have direct interaction with FDA officials
  • Consultants
  • Quality system auditors

Instructor : Steven Walfish
Product Id : 30383PACK

Overview: This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.

Areas Covered in the Session:
  • How to collect a sample
  • What are the two types of error (Type I and Type II)
  • How to calculate sample sizes for variables data
  • How to calculate sample sizes for attribute data
  • Using confidence intervals on Cpk to calculate a sample size
  • Using binomial confidence intervals

Who Will Benefit:
  • Management
  • Research and Development
  • Regulatory Affairs personnel
  • Quality assurance/quality control personnel
  • Auditors and inspectors

Instructor : Leo Lagrotte
Product Id : 30383PACK

Overview: As an experienced FDA medical device investigator, many firms have failed to fully incorporate the requirements of 21 CFR 803 when establishing and implementing their reporting procedures.

This webinar will assist the medial device manufacturer with determining what FDA requirements must be incorporated into the procedures and the definitions of various terminology used in the regulation. The decision making process as to when a Medical Device Report (MDR) must be filed is the single most area where device firms fails to make rational or informed decisions.

Why should you Attend: Medical Device manufacturers are aware that if an end user reports an injury to them purported to be the result of a malfunction of their device, that they must report this incident with FDA. What they fail to always take into consideration are the other incidents that also require a Medical Device Report 3500A be filed with FDA.

Some medical device firms fail to properly establish Medical Device Reporting procedures to capture all the requirements in 21 CFR 803. Sufficient time will be provided for Q&A.

Areas Covered in the Session:
  • What should be included in your Medical Device Reporting Procedures
  • What is a Medical Device Report 3500A
  • What is eSubmitter
  • Definitions of Serious Injury
  • When to report to FDA
  • How to report to FDA
  • What can happen when you fail to report.

Who Will Benefit:
  • All Medical Device manufacturers regardless of Class of Medical Device

Leo Lagrotte Currently serves as a Senior Regulatory Consultant for Quality Solutions & Support, LLC, a consulting practice offering auditing, training and advising to small, medium and large Medical Device and Radiation Emitting Device manufacturers as a follow-up to 20 plus years’ experience with the FDA and USDA. Mr. Lagrotte’s previous regulatory service was preceded by military service as a commissioned Officer in the US Army, and twenty plus years as a civilian owner/operator of retail food establishments including bakeries, restaurants and catering.

His experience with the FDA commenced as an investigator in Florida District/Tampa Resident Post in 2001 conducting inspections of predominately food processing establishments including all HACCP programs, LACF and Acidified Foods then advancing to Medical Devices in 2003 with the Level II Certified Medical Device Investigator (one of forty-four nationally) in 2005 and Southeast Regional Electro-Optics Specialist for Lasers and UV devices both with medical and industrial application in 2004. He also served on the Medical Device Inspection Cadre and conducted over thirty-five foreign inspections of Medical Device, Laser, and X-Ray manufacturers. During the course of his duties with FDA, Mr. Lagrotte conducted over 500 Establishment Inspections domestically. Presently, Mr. Lagrotte’s focus is to assist the medical device and rad health community in meeting or exceeding compliance with all FDA regulations and Notified Bodies requirements for certifications, completing 510(k) and PMA submissions and responding to regulating officials as necessary on behalf of clients.

At FDA and USDA he received numerous national awards / recognition certificates for exemplary performance. In 2007, he was nominated by Florida District for the Patrick Pouzar Investigator of the Year Award for exceptional performance, integrity and reliability and the FDA Outstanding Service Award in 2011.

Instructor : Jonathan M. Lewis
Product Id : 30383PACK

Overview: Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.

Why should you Attend: If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:
  • How can your company be prepared for an FDA inspection?
  • How should your company respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
  • What can an FDA inspector legally ask for during an inspection and what can you refuse to show the investigator?

Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.

Areas Covered in the Session:
  • Define the steps necessary to prepare for an FDA inspection
  • Discuss details surrounding the management of inspections from announcement to close out meeting
  • Offer responses to FAQs regarding typical inspector requests during inspections
  • Define the methodology for responding to 483 and warning letters
  • Discuss common pitfalls to avoid during an inspection
  • Define the steps necessary to prepare for an FDA inspection
  • Discuss details surrounding the management of inspections from announcement to close out meeting
  • Offer responses to FAQs regarding typical inspector requests during inspections
  • Define the methodology for responding to 483 and warning letters
  • Discuss common pitfalls to avoid during an inspection
  • Define the steps necessary to prepare for an FDA inspection

Who Will Benefit:
  • Internal Auditors
  • Regulators
  • Legal Departments
  • Compliance Officers
  • Validation Managers
  • QC Managers
  • QA Managers

Instructor : Angela Bazigos
Product Id : 30383PACK

Overview: This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Why should you attend: Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Areas Covered in the Session:
  • Requirements for Excel Spreadsheets
  • FDA Part 11 Validation Guidance
  • Compliance Problems with Spreadsheets
  • Design Specifications for 21 CFR 11 compliance
  • How does the FDA Design and Use spreadsheets
  • Documentation for Part 11
  • Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

Who Will Benefit:
  • Quality Managers
  • Quality Engineers
  • Small business owners
  • Internal and external auditors
  • Management Reps
  • FDA inspectors
  • Consultants

Instructor : Angela Bazigos
Product Id : 30383PACK

Overview: This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by explanation on how to get from regulations to the SOP. Finally, Best Practices for creating, implementing and maintaining SOPs using a risk based approach and getting SOPs ready for inspection will be presented.

Why you should attend: Standard Operating Procedures (SOPs) are required by law for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. Worse, this often leads to many regulatory errors that first come to light during an FDA audit.
This webinar will show you how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

Areas Covered In the Session:
  • SOPs and their relation to the regulations
  • SOPs as part of the company's regulatory infrastructure
  • SOP on SOPs and how to ensure conciseness, consistency and ease of use
  • Risk Based approach on SOP Best Practices for creation and maintenance
  • Training on SOPs
  • Tools for SOP tracking and when is validation required
  • What the FDA looks for in SOPs during an inspection

Who will benefit:
  • Anyone that creates / maintains SOPs
  • VP, Director, Manager of any dept that writes SOPs or performs training
  • QA / QC
  • Regulatory Affairs

Instructor : Angela Bazigos
Product Id : 30383PACK

Overview: This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

Why you should attend: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company and the industry, and provide guidance on how your company can ensure that they have a successful inspection.

Areas Covered In the Session:
  • What is FDA's most current thinking related to computers and electronic records?
  • What are the inspection trends?
  • What are most frequent recent citations for Part11?
  • What are the most frequent deviations for computer system validation?
  • Under which circumstances can inspectors exercise enforcement discretion?
  • How important is risk based Part11 compliance?

Who will benefit:
  • Everybody using computers in FDA Regulated Environments
  • IT Manager and Staff
  • QA Managers and Personnel
  • Regulatory Affairs
  • Training Departments
  • Consultants
  • Validation Specialists

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