ComplianceOnline

Raw material requirements in a cGMP environment are often overlooked as a company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion.

This highly interactive two day seminar on raw material requirements in a cGMP environment will:

  • Consider Health Canada, FDA, USP and EP requirements.
  • Examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2, 3 and commercial production.
  • Cover testing requirements during each phase and what may be optional (regulatory risk) until the product moves to its next phase.
  • Determine what options exist - even within a Phase 2 or Phase 3 testing framework.
  • Discuss compendial vs. non-compendial testing and how to respond when no method is available.
  • Discuss how a 90 percent vs. a 90.0 percent minimum purity analysis can delay initiation of testing.
  • Explore the number of lots required for testing before reduced testing might occur and why some companies don't accept this route.
  • Review the use of individual samples vs. composite samples for testing.
  • Explore ASQ testing to include how to choose attributes and sample size.

The objective of this two day seminar is to explore raw materials and their requirements – issues and solutions. It will also explore how water impacts the final product since water is the single largest raw material that is used within most processes. Another objective is to assure that your organization is maintaining itself within a cGMP compliance framework. Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.

Learning Objectives:

Upon completing this course on raw material requirements in a cGMP environment participants will:

  • Understand how various types of raw materials may impact the user.
  • Learn of the impact of raw materials in the timely production of a product.
  • Determine the single most used raw material in large molecule production and what it means to the user.
  • Find the sources of analyses assistance for raw materials.
  • Appreciate the requirements for Phase 1 through commercial manufacturing.
  • Initiation of additional testing -- when?
  • Examination of regulatory risk (ICH Q9).
  • Why use compendial testing in lieu non-compendial testing.
  • Testing requirements -- when is enough?
  • The impact of ASQ on sample size and attribute testing.
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who Will Benefit:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality Control
  • Microbiology
  • Document control specialists
  • R & D
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • The various raw materials and the user impact
  • Impact of raw materials in the timely production of a product
  • The impact of the single most used raw material in large molecule production and its impact upon the user
  • The regulatory requirements for Phase 1 through commercial manufacturing
  • The use of additional testing – does one only review the C of A
Day 02(8:30 AM - 4:30 PM)
  • The use of compendial testing in lieu of non-compendial testing – pros and cons
  • Regulatory risk (ICH Q9) with raw materials
  • Testing requirements – how to sample
  • Testing requirements – how to test
  • The impact of ASQ on sample size and attribute testing
  • Case Studies – Time to apply the previous two days
  • 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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Seminar One Registration

January 26-27, 2017, Orlando, FL
(Registrations till December 20, 2016 - $1599)
(Registrations till January 10, 2017 - $1699)
(Registrations after January 10, 2017 - $1899)

$2,099.00

Seminar One Registration (With 2 Nights Stay)

January 26-27, 2017, Orlando, FL

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Save $2,295.00

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January 26-27, 2017, Orlando, FL
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The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.


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Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Online using Credit card

$1,599.00

Seminar One Registration

March 13-14, 2017, San Francisco, CA
(Registrations till December 20, 2016 - $1599)
(Registrations till January 10, 2017 - $1699)
(Registrations after January 10, 2017 - $1899)




The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.


For discounts on multiple registrations, contact customer care at +1-888-717-2436.

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
2479 East Bayshore Road Suite 200
Palo Alto, CA 94303
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ customercare@complianceonline.com

Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

1

Orlando, FL
January 26-27, 2017

Hotel

The Citrus Club
255 S Orange Ave,
Orlando, FL 32801, USA

Tel:407-843-1080

How to Reach

General Driving Directions:

Driving directions from Orlando International Airport - 12.8 miles:
  • Head north on S Access Rd/Jeff Fuqua Blvd Continue to follow Jeff Fuqua Blvd
  • Keep left to continue on S Semoran Blvd Use the right lane to take the ramp to Downtown/Orlando Merge onto FL-408 W/Hwy 408 W
  • Keep left at the fork to stay on FL-408 W Use the right 2 lanes to take exit 11A for FL-15 toward Rosalind Avenue
  • Use the right lane to turn left onto E South St Turn right onto S Rosalind Ave
  • Turn left at the 3rd cross street onto E Pine St Turn left at the 3rd cross street onto S Orange Ave Destination will be on the left
Select hotels close to meeting venue:
  • 299 ft | 1 min walk | Grand Bohemian Hotel Orlando | 325 S Orange Ave, Orlando, FL 32801 | Marriott.com | (407) 313-9000 | $309/night
  • 0.2 mi | 5 min walk | Aloft Orlando Downtown | 500 S Orange Ave, Orlando, FL 32801 | aloftorlandodowntown.com | (407) 380-3500 | $200/night
  • 0.6 mi | 10 min walk | Courtyard at Lake Lucerne | 211 North Lucerne Circle West, Orlando, FL 32801 | orlandohistoricinn.com | (407) 648-5188 | $140/night
  • 0.3 mi | 7 min walk | Embassy Suites by Hilton Orlando Downtown | 191 E Pine St, Orlando, FL 32801 | embassysuites3.hilton.com | (407) 841-1000 | $209/night

Note: Room rates at listed hotels are based upon best available pricing at time of announcement. No room block at this time. We could potentially get a room block at a nearby hotel.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

2

San Francisco, CA
March 13-14, 2017

Hotel

Hilton San Francisco Airport Bayfront
600 Airport Blvd,
Burlingame, California, 94010, United States

Tel:+1-650-340-8500

How to Reach

General Driving Directions:

Driving directions from San Francisco International Airport – 4 miles:
  • Exit airport 101 South towards San Jose.
  • Take Broadway/Burlingame exit.
  • Take 2nd right to overpass to other side of freeway. 1st light, turn right.
  • Next light turn left onto Airport Blvd. Hotel is located in 1 mile.
Driving directions from San Jose International Airport – 32 miles:
  • Start out going Southeast on Airport Blvd.
  • Turn slight Left to CA-87/ Skyport Dr.
  • Merge onto CA -87 N. via the ramp to US-101 N.
  • Take US-101 N. Take Anza exit and turn right on Airport Blvd. Hotel is on the left.
Driving directions from Metropolitan Oakland International – 32 miles:
  • Exit airport and turn left onto Davis/CA-61.
  • Merge onto I-880 toward San Jose.
  • Take exit 27 toward CA-92 toward San Mateo/Half Moon Bay.
  • Cross the bridge and merge onto US-101 N. Exit Peninsula Ave, exit 417B. Left on Airport to the hotel.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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Testimonials

See What People Say About Us

The seminar was well coordinated and organized. I like how speaker point out to links for more details.

Quality Control,

Gilead Science

The interaction between the presenter and participant is great. ComplianceOnline.com provides useful courses and practical seminars.

QC Lab Supervisor,

Revance Therapeutics

One of my colleagues referred me to this seminar. The subjects are well chosen and presenter is very knowledgeable. I liked the session on "ASQ Sampling, Supplier Change Notifications".

QC Sr. Specialist,

Raw Material Support,

Bayer HealthCare LLC

I like the info provided about "Vendor Qualification Requirements".

Senior Associate,

Quality Assurance,

Arbutus Biopharma Corporation

I was looking for a good overview of the RM World and speaker provided in-depth knowledge about it. I liked all sessions of this seminar. Speaker is very knowledgeable.

Supervisor,

Laboratory Operations,

Upsher-Smith Laboratories, Inc.

I liked the case studies and presentation given on day 2 of seminar.

Director CMC,

Dermira, Inc.

Real world examples of warning letters are very useful.

Supplier Quality,

Sanofi Pasteur Inc.

Length of the program is appropriate and the support material are very useful.

Chemistry Specialist,

Bayer HealthCare LLC

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If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

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  • Exclusive stall at the entrance
  • A full page brochure advert
Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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Local Attractions of Orlando, FL

Walt Disney World Resort

Walt Disney World Resort

This massive, world-famous theme park includes Magic Kingdom Park, Disney - MGM Studios, Epcot, Disney's Animal Kingdom, Downtown Disney, and more.

Magic Kingdom Park

Magic Kingdom Park

Opened in October of 1971. One of the most famous theme parks in the world featuring Cinderella's castle with classic rides like Pirates of the Caribbean, Haunted Mansion, Space Mountain, Country Bear Jamboree, Hall of Presidents, etc. Frontierland, Tomorrowland, Liberty Square, Adventureland, and Fantasyland, Great for families with kids 10 and younger.

Universal Studios Orlando

Universal Studios Orlando

Theme studios park features Jaws, T2, Twister, Men In Black, etc. and various back lot sets used in the movies. CityWalk is an entertainment venue with many restaurants, night clubs, retails stores and a great party atmosphere. Movie theatre near the entrance. Also Hard Rock Cafe, Jimmy Buffet's Margaritaville, Emiril's, NASCAR Cafe.

Wet 'n Wild

Wet 'n Wild

Have a splashing good time at one of the country's premier water parks, offering rides for all ages.

Pointe Orlando

Pointe Orlando

Featuring open-air shopping, dining and entertainment, with more than 40 specialty retailers, delicious restaurants, and exciting entertainment.

Holy Land Experience

Holy Land Experience

The Living Bible theme park features a re-creation of ancient Jerusalem, craft shops, performances, food stands, and the Temple of the Great King.

Local Attractions of San Francisco, CA

Think Escape Party Bus

Think Escape Party Bus
San Francisco Bay Area

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.

Alcatraz Lunch Cruise

Alcatraz Lunch Cruise

The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

Luxury Catamaran Sailing Cruise

Luxury Catamaran Sailing Cruise

A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

City Kayak

City Kayak

City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

Think Escape Casino

Think Escape Casino Tour
San Francisco Bay Area

San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity

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