Overview: Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data.

Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented. This seminar will provide a good understanding on how to effectively prepare, conducts and document method validation experiments for FDA and ISO 17025 compliance.

Reference material for easy implementation:

• SOP: Validation of Analytical Methods
  
• Checklist: Validation of Analytical Methods
  
• 65-page Primer: Validation of Analytical Methods

Overview: Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance.

To ensure success and avoid those frustrating, embarrassing discussions of missing or doubtful data, laboratory personnel need to be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. According to the FDA, if it isn't written down, it didn't happen. As well, if it isn't written down clearly, it didn't happen either. GMP compliance (21CFR, Part 211 and Eudralex, Volume 4) requires the use of good documentation practices. These practices apply to all pharmaceutical manufacturing and support areas. Good Documentation Practices describe the required activities and steps to use when recording data and other handwritten entries. Personnel, who work with documentation must be informed of these requirements, recognize their significance to their job and be aware of the consequences of non-compliance. During this webinar, you will review agency and industry standard expectations of Good Documentation Practices plus see examples of these practices (both good and bad!) as they apply to the pharmaceutical laboratory.

Why Should You Attend:

• Discover what the FDA and EU regulations say about documentation
  
• Learn what your signature and/or initials mean on a document
  
• See how to handle and manage data entry and errors
  
• Review "Do's" and "Don'ts" of documentation practices
  
• Discuss rounding and limit expression determinations
  
• Recognize how to sign, date and label data and records
  
• Identify non-compliant documentation practices
  
• Demonstrate how to attach raw data to forms and lab notebooks
  
• Explore what FDA investigators actually look for during a lab inspection

Areas Covered in the Session:

• 21CFR and Eudralex references to documentation
  
• Correcting errors and omissions
  
• Dates and formats
  
• Meanings of initials and signatures
  
• Use of "NA"
  
• Comments and explanations
  
• Handling raw data (charts, strips, printouts)
  
• Blanks
  
• Entering numerical data
  
• OOS Documentation Expectations
  
• FDA Investigator strategies

Who Will Benefit:

• Chemists and Analysts
  
• Laboratory Technicians
  
• Laboratory Supervisors
  
• Laboratory Managers
  
• QA Auditors of Laboratory Documents
  
• Metrology personnel

Overview: Life sciences companies should regularly audit and assess computer systems for 21CFR Part 11 compliance, both their internal systems used in support of regulated GxP activities as well as systems used by their contract vendors for manufacturing, laboratory testing, drug safety and clinical studies. This is done routinely as self-assessment and inventory of existing systems, during the implementation of new systems, as during vendor qualification and periodic audits.

A methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory is presented, along with templates and forms attendees may modify for their own business.  Case studies are presented showing the outcomes for three regulatory inspections at companies conducted after following this methodology.

"Show me how you manage your computer systems in compliance with 21CFR Part 11." These words from an FDA or other regulatory inspector can send shivers down the spines of your Lab Managers, Information System Manager,  End Users and Quality Assurance Managers. This presentation will describe a process which has prepared several pharmaceutical companies to answer this question accurately, completely and to the great satisfaction of the inspectors. We will show how to inventory the site, assess the compliance risk of existing systems, implement new systems, remediate any non-compliance found, prepare SOPs and quality policies, collate the required documentation and train the staff. We will learn how to prepare and present a concise and comprehensive presentation to regulatory inspectors. Preparation and knowing in advance the expectations and required deliverables for a successful inspection is critical to your pharmaceutical, medical device, biotechnology or software company. Case studies are presented showing the outcomes for three inspections at companies following this methodology.

Areas Covered In the Session:

• 21CFR Part 11 Requirements
  
• Regulatory Inspections of Computer Systems
  
• Required Policies and Procedures
  
• Training
  
• Performing a Comprehensive Inventory: Team Effort
  
• System Inventory Assessment - Preliminary Risk Assessment
  
• Compliance Assessment - Compliance Risk Analysis, Gap Analysis and Corrective Actions
  
• Remediation Plans and Schedules
  
• Presenting to the Inspector
  
• Case Studies: Federal and State Regulatory Inspections

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 data systems will also benefit.

The employees who will benefit include:

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

Overview: This presentation will review a methodology for implementing Risk-Based Validation of test equipment, facilities and analytical instruments used in GLP, cGMP and GCP facilities.

A case study is presented for the construction qualification, relocation and new equipment installation for a cGMP facility. The cost and time savings associated with using risk-based validation will be presented. Over 3,000 systems or pieces of equipment were installed or relocated in a short time frame at a substantially reduced cost. A risk-based approach to validation was employed, dramatically reducing the cost and time for facility qualification.  Comments by regulatory inspectors will be discussed.

Why should you attend:
How much validation is enough?  How much is too much? When should you validate what system? Risk-based validation is the new and FDA-preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.

Overview: The analytical instruments and equipment used in GXP laboratories must be calibrated and qualified for use in regulated testing.

This includes quality control labs attached to cGMP facilities, GLP labs supporting animal toxicology studies and GCP labs supporting clinical trials. Additionally, labs supporting EPA studies are also regulated. This seminar will review the regulations that cover each environment and present simple and effective strategies for satisfying the requirements. The impact of USP <1058> on analytical instrument qualification will be reviewed and the newest regulation will be presented in a simple and understandable way. The interaction of calibration, qualification, method validation and equipment maintenance on laboratory compliance and data quality will be discussed.

Why should you attend:
The analytical instruments and laboratory equipment are easy targets for inspectors looking to cite observations of non-compliance.  Are yours ready for the internal QA and external regulatory inspectors?

Areas Covered in the Session:

• Regulatory requirements for analytical instrument qualification
  
• Calibration and Metrology Programs
  
• USP <1058>
  
• ICH Q2
  
• GXP
  
• Equipment and Instruments - similarities and differences

Who Will Benefit:This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. The employees who will benefit include:

• QC managers and personnel
  
• QA managers and personnel
  
• Information Technology managers and personnel
  
• Validation specialists
  
• Facility staff

Overview: Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use.

Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify test and document.

For easy implementation, attendees will receive:

• 4 SOPs
  
• User Requirement Specifications (URS) for analytical equipment
• Change control for analytical equipment
• Qualification of equipment
• Allocating Analytical Instruments to USP <1058> Categories
• Allocating Analytical Instruments to USP <1058> Categories

Areas Covered in the Session:

• Operational lab equipment requirements for calibration and qualification
  
• Most common inspection problems
  
• USP Chapter <1058>: Analytical Instrument Qualification
  
• Development of an effective equipment qualification master plan
  
• Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification
  
• Allocating equipment to qualification categories A, B and C
  
• Qualification and documentation requirements for each category
  
• Going through the category example list
  
• 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:

• QA managers and personnel
  
• Analysts and lab managers
  
• Analysts
  
• QA managers and personnel
  
• Regulatory affairs
  
• Training departments
  
• Documentation department
  
• Consultans

Overview: Complying with GLP regulations can increase the cost of a laboratory up to 30%. Companies or employees either don't know exactly what GLP really means, what procedures are required and how to implement GLP regulations.

Lack of GLP knowledge is also an inspection issue as training plans should include basic GLP knowledge for everybody working in a GLP environment This seminar will give a good understanding of GLP regulations and recommendations and tools for implementation.

For easy implementation, Attendees will receive the Labcompliance documents:

• Good Laboratory Practices and Current Good Manufacturing Practices: 120 pages e-book
  
• Gap Analysis/Checklist: Good Laboratory Practice Regulations
• SOP: Archiving GLP Data and Other Documents