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

Overview: This presentation will cover the contents of the guidance that was given.

FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP.

Overview: When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

So far there have not been official guidance on what exactly is expected to maintain 'the validated state'. Now the USP is preparing for a general chapter and the FDA has released an official guidance on how to conduct and document method transfer. The guide has been developed for medicated feed assays but the principles can be applied to other methods. Now it is a good time to learn how to conduct and document method transfer for FDA compliance.

Overview: Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument 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 or re-qualify, test and document.  The  main reason is that unlike for analytical methods there are no clear standards for equipment qualification. This has changed. The USP has developed a new standard for analytical instrument qualification (AIQ).

Reference material for easy implementation:

• SOP: Analytical Instrument Qualification for <1058>
  
• SOP: Allocating Analytical Instruments to USP <1058> categories
  
• SOP: Procedures and deliverables for USP <1058> categories

Areas Covered in the Session:

• FDA and EU analytical instrument requirements
  
• Most common inspection problems
  
• Terminology, scope and principles of US chapter <1058>.
  
• AIQ and its relation to method validation, system suitability testing and quality control checks
  
• Essential steps for AIQ: DQ, IQ, OQ, PQ
  
• Purpose and contents of design qualification, installation qualification, operational qualification, performance qualification
  
• Allocation of instruments to the three categories A, B and C
  
• Procedures and validation deliverables for the three categories
  
• Recommendations for firmware and software validation
  
• Roles and responsibilities: QA, manufacturer, user
  
• Approach for automated systems (incl. firmware/computer systems)
  
• Qualification of existing systems
  
• Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
  
• Recommendations for effective implementation

Who Will Benefit:

• Laboratory Managers and Staff
  
• Analysts
  
• QA Managers and Personnel
  
• Regulatory Affairs
  
• Training Departments
  
• Documentation Department
  
• Consultants
  
• Validation Specialists
  
• Regulatory Affairs
  
• Training Departments
  
• Documentation Department
  
• Consultants

Overview: When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

So far there has not been an official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published a proposal for a general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. The new USP chapter will become official with USP 35. Now it is a good time to learn how to conduct and document method transfer. This seminar will give a good understanding of USP and FDA requirement and provide recommendations and tools for effective implementation.

Reference Material:

For easy implementation, attendees will receive

• SOP: Transfer of Analytical Methods
  
• Checklist: Transfer of Analytical Methods and Procedures
  
• Master Plan template and examples: - Transfer of Analytical Methods and procedures

Areas Covered in the Session:

• FDA and International expectations for method transfer
  
• Examples of FDA warning letters and how to avoid them
  
• The FDA Guidance on method transfer.
  
• The proposal for a new USP chapter <1224>: history, status, future
  
• Four approaches for analytical method transfer and testing
  
• Responsibilities of the transferring and receiving laboratory
  
• Developing a transfer plan and a pre-approval protocol
  
• Conducting comparative studies
  
• Criteria and approaches for risk based testing: what, when, how much?
  
• The importance and selection of acceptance criteria
  
• Dealing with technology transfer: validation requirements, regulatory notification.
  
• Method transfer from standard HPLC to UHPLC
  
• Most likely failures during method transfer
  
• Handling deviations from documented acceptance criteria
  
• Criteria for transfer waiver (omission of formal transfer)

Who Will Benefit:

• Analysts
  
• Lab Supervisors and Managers
  
• QA managers and personnel
  
• Analysts
  
• Consultants
  
• Teachers

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: 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 employees must follow good documentation practices.

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) 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 1-hour webinar, we will review the Good Documentation Practices plus demonstrate examples of these practices (both good and bad!) as they apply to the pharmaceutical arena.

Why you should attend: The Learning Objectives of this presentation include:

• Discover what the regulations say about documentation practices
  
• Learn what your signature and/or initials mean on a document
  
• See how to correct errors and omissions in data entry
  
• Learn "Do's" and "Don'ts" of documentation practices
  
• Learn how to attach raw data to records
  
• Review rounding and limit expression determinations

Areas Covered in the Session:

• 21CFR Part 211 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

Who Will Benefit:

• Production personnel (operators, supervisors)
  
• Laboratory personnel (chemists, technicians, supervisors)
  
• Batch record reviewers
  
• QA Auditors of Production and Laboratory Documents
  
• Validation, Engineering
  
• Maintenance personnel (mechanics, supervisors)
  
• Warehousing personnel

Overview: On July 8, 2010, the FDA announced to soon conduct a series of inspections related to 21 CFR Part 11.

FDA made it very clear that the focus of the inspections will on most critical issues the industry had with Part 11 in the past. The best way to find out what the issues are is to look at recent FDA 483 form inspectional observations and warning letters related to computer system validation and Part 11 compliance. Just from 2007-2010, there have already been more than 30 such warning letters, some with disastrous consequences for inspected companies. This seminar will give an overview of FDA inspection findings and recommendations on how to avoid them.

For easy implementation, Attendees will receive:

• Part 11 Checklist
  
• Computer System Validation Master Plan
  
• Case Studies
• How to avoid Part 11 related 483's and Warning Letters
• How to respond to Part 11 related 483's and Warning Letters
• 30 FDA Warning Letters from 2007 to 2010 (Web downloads)

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

Overview: The class will cover the understanding the properties of single test results and how they may be compared.

There are many problems that arise from a misunderstanding of the properties of single data sets and the problems are compounded when data sets are compared. The discussion will cover the misconceptions and present methods to allow proper comparisons, while considering the risks inherent in decisions based on analytical data.

Areas Covered in the Session:

• Averages and their properties that affect decision making.
  
• The proper way to compare averages.
  
• The selection of sample sizes with the attendant risks.
  
• The interaction of variation and sample sizes.
  
• How to compare the variation observed in two different data sets.
  
• How to make predictions of intervals for future data, and the use of these predictions for setting specifications.

Who Will Benefit:

• Workers in Quality Control Laboratories.
  
• Supervisors of workers who perform analytical testing.
  
• Managers who must make decisions based on analytical data.
  
• Planners who must make predictions of future performance based on current test data.
  
• Reviewers who must understand the relationships among analytical data.