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The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs). These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The lifecycle concept, new to these Guidances, link product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. These guidances also support process improvement and innovation through sound science and risk management. The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing.

Each facility, whether producing small or large molecules requires both an overall Site Validation Plan as well as specific validation plans to manage the multiplicity of validations required to confirm the successful manufacture of each of its products.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

This two day, interactive Seminar which provides a conduit to enhance your understanding of the Continued Process Verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.

Common questions asked by the users of Process Validation include;

  • How does one integrate these two different concepts (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge?
  • Do they exist independently of each other or do they complement each other to enhance, build and provide a product that neither alone could. Questions that may arise include where are cGMPs initiated?
  • To what extent must they be used? Since Stage 3 extends through commercial batch manufacturing, what happens to Phase 3?
  • Does it follow along or with Stage 3? Questions that exist include how one manages special situations to include viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests to include DNA and host cell protein.

These questions will be addressed within Stage 2 as presented here and include utilization of Process Validation and Phase 1, 2 and 3, where their Guidances blend and where they remain distinct. In particular, Stage 3.

Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.

Learning Objectives:

Why these FDA Guidance/EU Guidelines for Industry - Process Validation is so important to the pharmaceutical and biotechnology industry.

  • What FDA segments are included and excluded within the "NEW" Process Validation.
  • Where does the Process Validation commence.
  • What are the Three Stages and Where Do They Apply within the NEW Process Validation.
  • How Stage 1 integrates with Phase 1.
  • The Validation approaches that are included within this Guidance document.
  • The Statutory and Regulatory Requirements for Process Validation.
  • An Introduction tPhase 1 Guidance for Industry and Its Application within the "NEW" Process Validation.
  • The Phase 1 Investigational Drug Requirements -- What is and What is NOT Required.
  • General Considerations for Process Validation - Stage 2 Process Qualification.
  • Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2.
  • General Considerations for Process Validation - Stage 3 Continued Process Verification.
  • A Review of EU Annex 15 and its Comparison tFDA's Process Validation Guidance.

Who Will Benefit:

Those who will benefit from this seminar include

  • Product Development
  • Project Management
  • Regulatory Compliance
  • Quality Assurance
  • Quality Control
  • Manufacturing and Facilities professionals who are required to develop and participate in understanding issues surrounding Process Validation.
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Day 01(8:30 AM - 5:00 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction, Goals and Objectives, Definitions. Process Validation - Its Importance within the Drug Industry
  • Interaction of the Three Stages with Process Validation
  • Validation Approaches, cGMPs in Clinical Supply Manufacture, Special Manufacturing Situations within Phase 1
  • The Requirements of Phase 1 Investigational Drug Requirements
  • Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2
Day 02(8:30 AM - 4:30 PM)
  • General Considerations for Process Validation – Stage 2 Process Qualifications
  • Special Considerations for Process Validation – Stage 2
  • General Considerations for Process Validation – Stage 3 Continued Process Verification
  • A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance
  • Concurrent Release of Process Performance Qualification (PPQ) Batches
  • Analytical Methodology and Process Validation; Warning Letter examples
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Barry A. Friedman

Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.

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Local Attractions of Austria, Vienna

Schonbrunn Palace

Schonbrunn Palace

Schonbrunn Palace is a former imperial summer residence located in Vienna. The 1,441-room Baroque palace is one of the most important architectural, cultural, and historical monuments in the country. Since the mid-1950s it has been a major tourist attraction. The history of the palace and its vast gardens spans over 300 years, reflecting the changing tastes, interests, and aspirations of successive Habsburg monarchs. The Great Parterre of Schönbrunn is lined with 32 sculptures, which represent deities and virtues. The sculpted garden space between the palace and the Sun Fountain is called the Great Parterre. The French garden contains, among other things, a maze. The complex includes many more attractions: besides the Tiergarten, an orangerie erected around 1755, staple luxuries of European palaces of its type, a palm house is noteworthy. Western parts were turned into English garden style in 1828–1852. The area called Meidlinger Vertiefung to the west of the castle was turned into a play area and drill ground for the children of the Habsburgs in the 19th century. At this time it was common to use parks for the military education of young princes.

Belvedere Palace

Belvedere Palace

The Belvedere is a historic building complex in Vienna, Austria, consisting of two Baroque palaces (the Upper and Lower Belvedere), the Orangery, and the Palace Stables. The buildings are set in a Baroque park landscape in the third district of the city, on the south-eastern edge of its centre. It houses the Belvedere museum. The grounds are set on a gentle gradient and include decorative tiered fountains and cascades, Baroque sculptures, and majestic wrought iron gates. The various sections of the original orangeries annexed to the Marble Hall were returned to their original condition and now provide space for the new exhibition rooms. The magnificent Baroque state rooms – the Marble Gallery, the Golden Room, and the Hall of Grotesques – remain unchanged and are open to the public.

Prater

Prater

The Prater is a large public park in Vienna's 2nd district (Leopoldstadt). The Wurstelprater amusement park, often simply called "Prater", lies in one corner of the Wiener Prater and includes the Wiener Riesenrad Ferris wheel. On the grounds of modern-day Kaiserwiese, an attraction called "Venice in Vienna” was established in 1895 by Gabor Steiner. The area included an artificial lagoon to simulate the canals of Venice, Italy. In 2004, major renovations to the Wurstelprater began, and a new underground railway line was finished and brought into service on May 11, 2008, which includes three stops along the Prater. The Hauptallee (main avenue) is the main artery, lined with horse chestnut trees, closed to motorists and known to sports enthusiasts from the annual Vienna Marathon. The Wiener Prater is home to the Liliputbahn, a narrow gauge railway. Another unusual object to be found in the Wiener Prater is the Republik Kugelmugel (Republic of Kugelmugel), a spherical micronation. The Wiener Prater also houses a planetarium and the Prater Museum.

Vienna Ring Road

Vienna Ring Road

The Ring Road (German: Ringstraße) is a circular ring road surrounding the Innere Stadt district of Vienna and is one of its main sights. Constructed in the mid-19th century after the dismantling of the city fortification walls, its architecture is typical of the eclectic, historicist style called Ringstraßenstil (Ring Road Style) of the 1860s to 1890s. Known for its unique architectural beauty and history, it has also been called the "Lord of the ring roads", and is inscribed by UNESCO as part of Vienna's World Heritage Site. Sigmund Freud was known to take a daily recreational walk around the Ring. The Ringstraße has several sections. It surrounds the central area of Vienna on all sides, except for the northeast, where its place is taken by the Franz-Josephs-Kai, the street going along the Donaukanal (a branch of the Danube).

Kunsthistorisches Museum

Kunsthistorisches Museum

The Kunsthistorisches Museum (English: "Museum of Art History", also often referred to as the "Museum of Fine Arts") is an art museum in Vienna. Housed in its festive palatial building on Ringstraße, it is crowned with an octagonal dome. The term Kunsthistorisches Museum applies to both the institution and the main building. It is the largest art museum in the country. It was opened around 1891 at the same time as the Naturhistorisches Museum, by Emperor Franz Joseph I of Austria-Hungary. The two museums have similar exteriors and face each other across Maria-Theresien-Platz. The museum's primary collections are those of the Habsburgs, particularly from the portrait and armour collections of Ferdinand of Tirol, the collections of Emperor Rudolph II, and the collection of paintings of Archduke Leopold Wilhelm.

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