| Annual GMP Training - Exploring Good Manufacturing Practices Updates and FDA Regulatory Expectations
Live 2-Session Web Training Series
Instructor:
Dr. Barry A. Friedman | October 7 &14
1:20 p.m. - 3:45 p.m. EDT |
Dear colleague,
Annual Good Manufacturing Practices (GMP) updates are required by the FDA to assure facility personnel maintain a current understanding of regulatory requirements. These regulations utilize 21 CFR Parts 210/211 as the basis for understanding; however, many other documents, to include FDA's Guidance(s) for Industry, and various other policies, to include ICH Q8, Q9 and Q10, enhance the basis for these updates and regulatory expectations.
Register NowEarly Bird Deadline: Thursday, September 30, 2010 |
|
Learning Benefits:
- Where the FDA is headed under its new commissioner
- Learning how GMP compliance can enhance the efficiency of your organization
- Determining if your organization is meeting all six Quality System requirements
- How to use a Warning Letter to improve the Quality within your facility
- How a quick response to follow-up with training may not be the correct response to an FDA 483/Warning Letter
- An opportunity to learn how others are meeting cGMP needs during the "live" Question and Answer period
|
| Conducting Successful OOS/OOT Investigations for Analytical Testing
Live 3-Session Web Training Series
|
October 19 - 21 & 26
1:20 p.m. - 3:45 p.m. EDT |
Deficiencies of OOS investigations continue to be the major cause of warning letters in the pharmaceutical industry. The FDA requires that all out-of-specification results be investigated; therefore, an effective and compliant quality management system requires well-documented, thorough investigations for OOS. Key challenges for many companies are having a clear understanding of regulatory expectations on how to handle OOS and OOT. Lack of consistency around investigation and root-cause analysis processes will lead to error and expensive laboratory activities.
Read More...
Register Now Early Bird Deadline: October 5, 2010 |
|
Learning Benefits:
- Understand regulatory expectations for OOS investigations
- Define documentation system for reporting data
- Build ruggedness into the analytical procedures to prevent OOS
- Build compliance into the investigation processes to minimize OOS
- Define and monitor Corrective and Preventive Actions
|
| A Successful Approach to Writing Effective SOPs
Live 2-Session Web Training Series
Instructor:
|
October 22 & 29
1:20 p.m. - 3:45 p.m. EDT |
The development and writing of Standard Operating Procedures (SOPs) are an integral part of a successful quality system as it provides operating personnel with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or task. All GMP manufacturing sites must have appropriate SOPs in place that detail the regularly recurring work activities conducted and/or documented within an organization to ensure consistent conformance to technical and quality system requirements, as well as regulatory obligations. Poorly written SOPs are of limited value.
|
|
Learning Benefits:
- What makes an effective SOP
- Review the regulatory requirements and expectations for procedures
- How to collect information that should be used in a procedure
- Identify why some SOPs are difficult to understand, use and are not readily accepted by the users
- Examine the difficulties in writing and using procedures
- Discuss different formats, sections and styles for procedures
|
Registration Fees:
2-Session Series:
Early Bird
� Single Attendee: $299 USD
� Small Group (Max 5 Attendees): $550 USD
� Medium Group (6 to 12 Attendees): $1,125 USD
� Large Group (13 to 20 Attendees): $1,650 USD
After Early Bird Deadline
� Single Attendee: $330 USD*
� Small Group (Max 5 Attendees): $595 USD
� Medium Group (6 to 12 Attendees): $1,250 USD
� Large Group (13 to 20 Attendees): $1,850 USD
3-Session Series: Early Bird
� Single Attendee: $399 USD
� Small Group (Max 5 Attendees): $740 USD
� Medium Group (6 to 12 Attendees): $1,500 USD
� Large Group (13 to 20 Attendees): $2,225 USD
After Early Bird Deadline
� Single Attendee: $440 USD*
� Small Group (Max 5 Attendees): $795 USD
� Medium Group (6 to 12 Attendees): $1,700 USD
� Large Group (13 to 20 Attendees): $2,500 USD
For 21 attendees or more, please contact us for custom pricing. Group rates include 14 days access to the recording.
Kind Regards,
Ardy Heydari
Sr. Account Manager Tel: 1.877.937.1616. ext. 228 |
|
|
|
| |
Dr. Barry A. Friedman
Barry A. Friedman, PhD, is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology... |
|
Ms. Kim Huynh-Ba | |
Kim Huynh-Ba is the Founder and Technical Director of Pharmalytik (www.pharmalytik.com). Kim has twenty-two years of experience in various analytical areas of pharmaceutical development with a primary focus in stability sciences, and previously held positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. |
| | |
Mr. Kerry Potter
Mr. Kerry Potter gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, as well as internal and external public relations. |
|
