Immediately following the 2012 PDA Annual Meeting, April 19th and 20th, PDA’s Training and Research Institute (PDA TRI) will be offering eight courses designed to complement what you’ve learned at the conference. Six of these courses have never been offered before! These courses will focus on Biotechnology and Bioprocessing, Sterile Dosage Forms, Manual Aseptic Processes, Process Validation and Verification, and more. Get the most out of your experience and receive a discount by registering for both the conference and one or more courses.

Reprocessing of Biopharmaceuticals

Location: JW Marriott Desert Ridge Resort, Phoenix, Arizona
Date: April 19, 2012
Duration: 1 Day
Time: 8:30 a.m. – 4:00 p.m.

Description

Occasionally, reprocessing of drug products becomes a necessary activity. There are both technological and regulatory issues which must be addressed when reprocessing becomes necessary. Reprocessing becomes more complicated when biotechnology-derived products are involved. This one day lecture course will provide guidance for the development and execution of reprocessing plans for these types of products. The issues and strategies which need to be considered will be discussed. Case-studies will be used during the course to provide practical examples of the application of the material presented. This course is based on a PDA Technical Report addressing the same subject.

This course will provide practical insights into both the regulatory and technological considerations which must be taken into consideration when reprocessing biotechnology-derived products. Participants will come away with an understanding not only of what the considerations are, but how to develop and implement reprocessing plans.

Who Should Attend

This course will be of value to process development, manufacturing, technical service and quality/regulatory affairs staff involved in planning, approving and executing reprocessing, including both managers and supervisors in these departments.

Objectives

Upon the completion of this course, you will be able to:

• Identify the pre and post-approval regulatory reporting considerations and requirements when planning reprocessing strategies for biotechnology-derived products
• Describe the contents of post-approval regulatory submissions for reprocessing of biotechnology-derived products
• Explain the difference between proactive and reactive reprocessing
• Discuss the requirements of investigations associated with reprocessing
• Create appropriate procedures governing reprocessing
• Apply the lessons learned from case studies of actual reprocessing activities to reprocessing operations in their jobs

Registration Fees

	Standard		Government / Health Authority / Academic
	Member	Non-Member	Member	Non-Member
Price on or before March 6, 2012	$895	$1,165	$600	$700
Price After March 6, 2012	$995	$1,295	$600	$700

Continuing Education

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #158 | ACPE #0116-0000-12-158-L04-P | 0.6 CEUs
Type of Activity: Knowledge

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Recommended Practices for Manual Aseptic Processes

Location: JW Marriott Desert Ridge Resort, Phoenix, Arizona
Date: April 19, 2012
Duration: 1 Day
Time: 8:30 a.m. – 4:00 p.m.

Description

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile during these operations. For large scale automated operations where operator interventions are infrequent, the verification of the ability of the process to produce sterile product is evaluated by the conduct of large scale automated media fills in a manner analogous to normal production.

Processes using all or partial manual procedures must also be evaluated by process verification testing. However, such manual operations present unique operational and evaluation challenges not generally encountered with automated operations. Manual aseptic processes rely heavily on individual operator proficiency. However, operational personnel and their activities are generally recognized as the greatest source of potential microbial contamination during manual aseptic processes. Reproducible human performance cannot be assumed over time.

These and other challenges posed by manual aseptic processing must be considered when designing the evaluation protocol. This course will provide a description of how to address the challenges posed in design, control and evaluation of manual aseptic processing. Topics such as personnel training and qualification, design of manual aseptic processes and evaluation of manual aseptic processing process simulations will be covered. The course is based on a PDA Technical Report addressing the same subject.

This course will provide valuable practical insights into the technological challenges associated with designing, operating and evaluating manual aseptic processing. Participants will come away with an understanding of how manual aseptic processes differ from automated ones, and what should be addressed as they work with manual aseptic processes in their own plants. They will also learn how process simulation testing to evaluate manual aseptic processing operation should be designed and carried out.

Who Should Attend

This course will be of value to operational personnel who design, carry out and evaluate manual aseptic processing; including personnel involved with compounding, filling, packaging, and quality assurance operations. Support staff, such as engineering and validation personnel will also benefit. The course will be suitable for supervisors and managers as well as personnel engaged in manual processing operations.

Objectives

Upon the completion of this course, you will be able to:

• Discuss the challenges associated with manual aseptic processing
• Describe the elements involved in the design of process simulation studies for manual aseptic processing
• Describe the elements involved in the design of process simulation studies for manual aseptic processing
• Explain the elements associated with training and qualification of personnel involved with manual aseptic processing
• Explain the differences to be considered when designing manual aseptic processing operations in unidirectional air flow and in isolators
• Apply the lessons learned to the design and conduct of manual aseptic processing operations in their jobs
• Design a protocol for the conduct of a process simulation test for manual processing

Registration Fees

	Standard		Government / Health Authority / Academic
	Member	Non-Member	Member	Non-Member
Price on or before March 6, 2012	$895	$1,165	$600	$700
Price After March 6, 2012	$995	$1,295	$600	$700

Continuing Education

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #216 | ACPE #0116-0000-12-216-L04-P | 0.6 CEUs
Type of Activity: Knowledge

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Biotechnology: Overview of Principles, Tools, Processes and Products

Location: JW Marriott Desert Ridge Resort, Phoenix, Arizona
Date: April 19-20, 2012
Duration: 2 Days
Time: 8:30 a.m. – 4:00 p.m.

Description

Biotechnology is the use of biological processes and components to provide useful products, services and tools for a variety of applications. It uses knowledge from a variety of disciplines such as molecular biology, biochemistry, chemistry, microbiology, chemical engineering and computing. This course is designed to provide biotechnologists and non-biotechnologists with a basic understanding of the theory, principles, techniques and potential of this rapidly moving field.

Topics covered include: scientific principles, overview of tools (recombinant DNA, genomics and gene arrays, proteomics, bioinformatics, etc.), biopharmaceutical product development, biomanufacturing strategies (protein expression, fermentation, cell culture, downstream processing and purification), and types of products and their applications in medicine. The course format includes a combination of lecture with interactive group discussions.

Who Should Attend

Managers, group leaders, supervisors, scientists and technicians from R&D and manufacturing units in biotech organizations who need an integrated overview of the field; Engineering/Validation and Quality Control/Quality Assurance staff persons moving into the biotechnology field; Career changers interested in learning the fundamentals of the biotechnology industry; Lawyers, architects and other individuals with limited background in biotechnology who work in biotech projects.

Objectives

Upon completion of this course, you will be able to:

• Define biotechnology and understand current applications of biotechnology and its products in the biopharmaceutical industry
• Discuss the fundamental tools and how they are used in biotechnology
• Explain the biopharmaceutical product and process development steps
• Describe the key steps in typical biopharmaceutical manufacturing processes

Faculty

Antonio Moreira, PhD, Vice Provost for Academic Affairs, University of Maryland Baltimore County

Registration Fees

	Standard		Government / Health Authority / Academic
	Member	Non-Member	Member	Non-Member
Price on or before March 6, 2012	$1,435	$1,705	$950	$1,050
Price After March 6, 2012	$1,595	$1,895	$950	$1,050

Continuing Education

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #279 | ACPE #0116-0000-10-279-L04-P | 1.2 CEUs
Type of Activity: Knowledge

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Implementation of Quality Risk Management for Commercial Pharmaceutical and Biotechnology Manufacturing Operations

Location: JW Marriott Desert Ridge Resort, Phoenix, Arizona
Date: April 19-20, 2012
Duration: 2 Days
Time: 8:30 a.m. – 4:00 p.m.

Description

This course will provide detailed guidance for application and implementation of quality risk management principles throughout the product lifecycle, with emphasis on quality risk management application during commercial manufacturing, and integrating quality risk management into the Pharmaceutical Quality System. The course will build on the content and principles of ICH Q9, Quality Risk Management. The application of quality risk management will be discussed from a life-cycle approach, from pharmaceutical development to technology transfer, commercial manufacturing, product discontinuation, and will include materials management and contract services. Case study examples of quality risk management application will be given for different types of manufacturing operations such as biotech API manufacturing, drug product manufacturing, packaging and labeling. This course is based on PDA Technical Reports addressing these subjects.

Modern quality systems utilize the principles of quality risk management to strengthen the decision-making process and aid in allocating resources in a rational way. This course will demonstrate how to utilize these principles as applied to the manufacture of pharmaceuticals and biopharmaceutical products. The use of case studies will help ensure that course participants can apply these principles to a variety of manufacturing operations in their jobs.

Who Should Attend

Managers and supervisors in manufacturing, technology transfer, quality assurance and regulatory affairs will benefit from this course.

Prerequisites

A basic understanding of risk management principles will be helpful to participants in this course.

Objectives

Upon completion of this course, you will be able to:

• Describe when, where, and how to apply quality risk management throughout the product lifecycle with emphasis on commercial manufacturing
• Plan quality risk management activities
• Execute risk assessments and develop an overall strategy for the use of different risk assessment tools
• Establish a quality risk management policy and implement the essential elements for risk management in your organization
• Apply the principles learned to conduct risk management activities for a variety of product-related and operational decisions in your job

Faculty

Jeffrey Hartman, Validation Manager, Merck
Emma Ramnarine, Head, Global Quality Risk Management, F. Hoffman-LaRoche Ltd.

Registration Fees

	Standard		Government / Health Authority / Academic
	Member	Non-Member	Member	Non-Member
Price on or before March 6, 2012	$1,435	$1,705	$950	$1,050
Price After March 6, 2012	$1,595	$1,895	$950	$1,050

Continuing Education

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #224 | ACPE #0116-0000-12-224-L04-P | 1.2 CEUs
Type of Activity: Knowledge

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Sterile Pharmaceutical Dosage Forms

Location: JW Marriott Desert Ridge Resort, Phoenix, Arizona
Date: April 19-20, 2012
Duration: 2 Days
Time: 8:30 a.m. – 4:00 p.m.

Description

This introductory two-day course on sterile dosage forms will address clean room facilities, environmental monitoring and control, sterilization principles, manufacturing unit operations, aseptic filling, dosage form development, packaging & stability requirements, validation of aseptic processing and product specific validation, QA/QC for parenterals, and regulatory trends.

Who Should Attend

The course is designed to provide a broad overview for individuals working in sterile manufacturing, QA/QC, microbiology, formulation development, package engineering, and compliance training.

Objectives

Upon completion of this course, you will be able to:

• Describe product specific validation for parenteral dosage forms
• Discuss aspects of dosage form development, packaging and stability
• Describe the chemical composition of endotoxins, their toxic effects, source and testing procedures
• Summarize the current cGMP regulatory and inspection trends for parenteral manufacturing

Faculty

John Ludwig, PhD, Executive Director, Pfizer Inc.

Registration Fees

	Standard		Government / Health Authority / Academic
	Member	Non-Member	Member	Non-Member
Price on or before March 6, 2012	$1,435	$1,705	$950	$1,050
Price After March 6, 2012	$1,595	$1,895	$950	$1,050

Continuing Education

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #352 | ACPE #0116-0000-11-352-L04-P | 1.2 CEUs
Type of Activity: Knowledge

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Process Validation and Verification: A Lifecycle Approach

Location: JW Marriott Desert Ridge Resort, Phoenix, Arizona
Date: April 19-20, 2012
Duration: 2 Days
Time: 8:30 a.m. – 4:00 p.m.

Description

The FDA has updated its recommendations to the traditional process validation program to encompass a new lifecycle approach. This course is designed to explain and facilitate the implementation of Process Validation (PV) and Continued Process Verification (CPV) from a practical perspective. The three stages of process validation activities will be addressed, from the design stage through commercial production. Statistical methods will be discussed along with the stages where they are most commonly used. There will be application of modern risk management and quality system tools and concepts. Other topics include Process Analytical Technology (PAT), Technology Transfer and Scale-Up, and Documentation/Knowledge Management. This course is based on a PDA Technical Report addressing the same subject.

Expectations for what is required to demonstrate that a manufacturing process has been and remains in a state of validation have changed dramatically with the publication of FDA's Process Validation Guidance. This course will provide participants with the knowledge they need to ensure that process validation strategies and approaches are consistent with current regulatory and quality system thinking. Attendees will be able to apply these concepts when they return to their jobs.

Who Should Attend

This course will be of value to individuals responsible for the design, execution and evaluation of validation strategies and activities. This includes managers and supervisors in operations, validation, engineering, statistics, quality assurance and regulatory affairs.

Objectives

Upon completion of this course, you will be able to:

• Explain the progression of lifecycle activities
• Interpret the three stages of process validation
• Utilize risk assessment and management tools for the process validation lifecycle
• Demonstrate Continued Process Verification
• Utilize statistical analysis tools
• Apply the concepts learned to the design, implementation and evaluation of process validation and verification strategies and activities in their jobs

Faculty

Scott Bozzone, PhD, Sr. Manager in Quality Systems Technical Services – Validation, Pfizer, Inc.

Registration Fees

	Standard		Government / Health Authority / Academic
	Member	Non-Member	Member	Non-Member
Price on or before March 6, 2012	$1,435	$1,705	$950	$1,050
Price After March 6, 2012	$1,595	$1,895	$950	$1,050

Continuing Education

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #320 | ACPE #0116-0000-12-320-L04-P | 1.2 CEUs
Type of Activity: Knowledge

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Process Simulation Testing for Aseptically Filled Products

Location: JW Marriott Desert Ridge Resort, Phoenix, Arizona
Date: April 20, 2011
Duration: 1 Day
Time: 8:30 a.m. – 4:00 p.m.

Description

The goal of aseptic processing operations is to prevent the contamination of materials intended to be sterile during these operations. The verification of the ability of the process to produce sterile product is evaluated by the conduct of large scale automated process simulation testing (media fills). This course, which is based on a recently revised PDA Technical Report addressing the same subject, will address all the various elements required in the design and execution of a media fill, including personnel qualification, media selection and preparation, filling considerations, interventions, duration and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.

Process simulation testing is expected as part of a firm's quality system to ensure the sterility of products manufactured using aseptic processing techniques. Participants in this course will come away with an up to date understanding of current scientific and regulatory advances in the design, conduct and interpretation of process simulations. The knowledge they gain can be applied immediately to media fill operations in their own jobs.

Who Should Attend

This course will be of value to managers and supervisors involved in the design, operation, evaluation and approval of process simulation testing. This includes persons working in operations, quality assurance, microbiology, and regulatory affairs. Individuals in facility engineering will also benefit from attendance.

Prerequisites

Individuals taking this course should have a basic understanding of aseptic manufacturing operations. This is not a course designed to teach the basic fundamentals of aseptic processing.

Objectives

Upon the completion of this course, you will be able to:

• Identify the updated scientific and regulatory technology and expectations in the design, operation and interpretation of process simulations
• Discuss process simulation concepts and principles such as the number and frequency of simulations, worst case and risk assessment and ongoing evaluations
• Describe how to use risk management as it applies to aseptic processing simulations
• Discuss how process simulations can be applied to various types of aseptically processed products (lyophilized products and powders)
• Explain why environmental monitoring is an important element of process simulations
• Discuss the necessary documentation associated with process simulations
• Apply modern concepts to establish appropriate acceptance criteria for media fills, evaluate the results and as necessary investigate any failures and recommend appropriate corrective and preventive actions

Faculty

Harold Baseman, Principal of ValSource and Task Force Co-Leader of PDA Technical Report 22 (Revised 2011); Process Simulation for Aseptically Filled Products

Hal Baseman is Chief Operating Officer and Principal at ValSource, LLC, a 110 employee validation consulting and service firm. He has over 30 years of experience in pharmaceutical operations, validation and regulatory compliance. Hal has held positions in executive management and technical operations at several drug manufacturing and consulting firms. Hal is a member of the PDA Board of Directors, Co-Chair of the PDA Science Advisory Board, Co-Leader of the PDA Validation Interest Group, Co-Chair of the PDA Aseptic Process Simulation Technical Report #22 Task Force on Aseptic Process Simulation, and was Co-Chair of the PDA Risk Management Task Force responsible for writing Technical Report #44 on Quality Risk Management of Aseptic Processes. Most recently Hal co-chaired and led the PDA response to the FDA on draft Process Validation Guidance. Hal is a long time member of the PDA and its Training Research Institute faculty. He is a frequent presenter on subjects related to Quality Risk Management, Validation, and Aseptic Processing. Hal was recently awarded the 2009 James P. Agalloco Award for Excellence in Education. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.

Registration Fees

	Standard		Government / Health Authority / Academic
	Member	Non-Member	Member	Non-Member
Price on or before March 6, 2012	$895	$1,165	$600	$700
Price After March 6, 2012	$995	$1,295	$600	$700

Continuing Education

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #374| ACPE #0116-0000-12-374-L04-P | 0.6 CEUs
Type of Activity: Knowledge

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Investigating Microbiological Data Deviations

Location: JW Marriott Desert Ridge Resort, Phoenix, Arizona
Date: April 20, 2012
Duration: 1 Day
Time: 8:30 a.m. – 4:00 p.m.

Description

Out of Specification (OOS) test results are sometimes encountered during analytical testing of drug substances and products. Existing FDA guidance addresses the investigation of OOS test results, but is silent on the subject of data deviations encountered in microbiological testing. However, these are often encountered in pharmaceutical quality control laboratories. This course will provide a practical approach which may be applied globally for the investigation of microbiological data deviations.

The roles of manufacturing, the testing laboratory and Quality Assurance will be considered, and fundamental elements to be addressed in writing reports summarizing those investigations will be covered. Flowcharts, checklists and process flow diagrams will be utilized to illustrate the concepts presented. This course is based on a PDA Technical Report addressing the same subject.

This course will provide practical insights into both the regulatory and scientific considerations which must be taken into consideration when investigating microbiological data deviations. Participants will come away with an understanding not only of what the considerations are, but a practical approach of how to design and conduct investigations into microbiological test data which appears inconsistent with expectations and trends.

Who Should Attend

This course will be of value to quality control staff who conduct and assess the results of microbiological testing. It will also be of benefit for those quality control and quality assurance staff who conduct investigations into microbiological data deviations and write and approve reports of those investigations. Analysts, laboratory supervisors and managers and quality assurance staff will all benefit from attendance at this course.

Objectives

Upon the completion of this course, you will be able to:

• Identify microbiological test results which deviate from anticipated results and trends
• Explain the responsibilities of laboratory, manufacturing and quality assurance staff in preparing for, conducting, reviewing and documenting investigations into microbiological data deviations
• Describe the essential elements of reports of investigations into microbiological data deviations
• Discuss the benefits of flowcharts, checklists and process flow diagrams as they apply to the investigation process
• Apply the concepts learned in situations involving microbiological data deviations when necessary in their daily jobs.

Registration Fees

	Standard		Government / Health Authority / Academic
	Member	Non-Member	Member	Non-Member
Price on or before March 6, 2012	$895	$1,165	$600	$700
Price After March 6, 2012	$995	$1,295	$600	$700

Continuing Education

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #441 | ACPE #0116-0000-12-441-L04-P | 0.6 CEUs
Type of Activity: Knowledge

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